Computer-assisted skull identification system using video superimposition

This system consists of two main units, namely a video superimposition system and a computer-assisted skull identification system. The video superimposition system is comprised of the following five parts: a skull-positioning box having a monochrome CCD camera, a photo-stand having a color CCD camera, a video image mixing device, a TV monitor and a videotape recorder. The computer-assisted skull identification system is composed of a host computer including our original application software, a film recorder and a color printer. After the determination of the orientation and size of the skull to those of the facial photograph using the video superimposition system, the skull and facial photograph images are digitized and stored within the computer, and then both digitized images are superimposed on the monitor. For the assessment of anatomical consistency between the digitized skull and face, the distance between the landmarks and the thickness of soft tissue of the anthropometrical points are semi-automatically measured on the monitor. The wipe images facilitates the comparison of positional relationships between the digitized skull and face. The software includes the polynomial functions and Fourier harmonic analysis for evaluating the match of the outline such as the forehead and mandibular line in both the digitized images.     

Case study: Forensic analysis of a Samsung digital video recorder

In May 2007, a case of potential child abuse was reported to the hospital where the victim was under observation. The child had been in the hospital for several months and there was hope that a digital video recorder (DVR) may have recorded the maltreatment of a hospitalized child. Unfortunately the recordings could not be found on the device by hospital security employees. The DVR was given to digital forensic examiners in an effort to recover footage. This article details how the system was examined, describing the steps that were taken to obtain information and how the information was interpreted. The methods described in this article can be applied to other similar devices.     

一起非正常死亡案件中行车记录仪视频检验及启示

随着行车记录仪功能的不断丰富及智能化程度的提升,其工作模式变得越来越多样化。行车记录仪录制的行车视频直观地记录了车辆行驶途中发生的道路交通事故,为案件侦查提供证据和线索。本文通过总结一起非正常死亡案件中行车记录仪视频的检验过程,回顾利用影像技术、电子物证技术以及开展现场实验等技术方法进行综合检验,最终查明行车记录仪的工作模式,认定在案发时段行车记录仪没有录制声音,为明确案件性质提供了重要线索。作者在此案件中所使用的检验方法也为行车记录仪视频的检验工作提供了参考。     

录音剪辑检验的实验研究

目的寻找录音剪辑的检验方法。方法进行模拟仿真实验。分别用标准盒式录音机、微型录音机和MP3录制样本，再用物理剪辑、录音机具编辑、软件编辑等3种方法对样本进行剪辑，最后用VS3．0语音工作站进行检验。结果找到剪辑点痕迹特征在时域波形图、宽带语谱图、窄带语谱图上的反映。结论利用“语意连贯性检验”、“背景噪声图谱连贯性检验”、“突变声痕检验”等方法可以实现对录音剪辑的检验。     

Medical device reporting--FDA. Final rule

The Food and Drug Administration (FDA) is issuing a final rule that requires manufacturers and importers of medical devices, including diagnostic devices, to report to FDA whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned and that the device or any other device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. FDA is taking this action under the Medical Device Amendments of 1976. The final rule is intended to assure that FDA is informed promptly of all serious problems or potentially serious problems associated with marketed devices. FDA is the principal public health agency responsible for ensuring that devices are safe and effective. To carry out its responsibilities, the agency needs to be informed whenever a manufacturer or importer receives or otherwise becomes aware of information about device problems. Only if FDA is provided with such information will it be able to evaluate the risk, if any, associated with a device and take whatever action is necessary to reduce or eliminate the public's exposure to this risk. Depending on the facts and circumstances, these steps could include contacting the manufacturer or importer of the device and monitoring its voluntary actions to respond to the problem, initiating a consumer or user education program, or initiating regulatory action, such as injunction, seizure, or other enforcement action.     

The Average Direct Current Offset Values for Small Digital Audio Recorders in an Acoustically Consistent Environment

In this research project, nine small digital audio recorders were tested using five sets of 30‐min recordings at all available recording modes, with consistent audio material, identical source and microphone locations, and identical acoustic environments. The averaged direct current (DC) offset values and standard deviations were measured for 30‐sec and 1‐, 2‐, 3‐, 6‐, 10‐, 15‐, and 30‐min segments. The research found an inverse association between segment lengths and the standard deviation values and that lengths beyond 30 min may not meaningfully reduce the standard deviation values. This research supports previous studies indicating that measured averaged DC offsets should only be used for exclusionary purposes in authenticity analyses and exhibit consistent values when the general acoustic environment and microphone/recorder configurations were held constant. Measured average DC offset values from exemplar recorders may not be directly comparable to those of submitted digital audio recordings without exactly duplicating the acoustic environment and microphone/recorder configurations.     

Medical devices: cardiovascular devices: reclassification of the arrhythmia detector and alarm. Final rule

The Food and Drug Administration (FDA) is reclassifying arrhythmia detector and alarm devices from class III to class II (special controls). This device is used to monitor an electrocardiogram (ECG) and to produce a visible or audible signal or alarm when an atrial or ventricular arrhythmia occurs. An atrial or ventricular arrhythmia occurs during a premature contraction or ventricular fibrillation. FDA is reclassifying this device based on new information contained in reclassification petitions regarding the device submitted by the Health Industry Manufacturers Association (HIMA) (now known as Advamed), Quinton Instrument Co., and Zymed Medical Instrumentation. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (the FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).     

Medical devices; reclassification of the shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is announcing that it is reclassifying the shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis intended to replace a shoulder joint from class III to class II (special controls). The agency is also announcing that it has issued an order in the form of a letter to the Orthopedic Surgical Manufacturers Association (OSMA) reclassifying the device. The special control that will apply is a guidance document entitled "Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis." The agency is classifying this device into class II because special controls, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls.     

Medical devices; retention in class III and effective date of requirement for premarket approval for three preamendments class III devices--FDA. Proposed rule; opportunity to request a change in classification

The Food and Drug Administration (FDA) is proposing to retain in class III, three preamendments class III medical devices, and is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for these devices. FDA believes that the suction antichoke device, the tongs antichoke device, and the implanted neuromuscular stimulator device should remain in class III because insufficient information exists to determine that special controls would provide reasonable assurance of their safety and effectiveness, and/or these devices present a potential unreasonable risk of illness or injury. The agency is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request the agency to change the classification of any of the devices based on new information.     

Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule

The Food and Drug Administration (FDA) is amending its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA). This final rule provides that a supplemental application submitted under certain FDA regulations is appropriate to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the drug, biologic, or device, as defined in other FDA regulations and guidance documents.     

Medical device reporting--FDA. Reproposal

The Food and Drug Administration (FDA) is issuing a revised proposal to require manufacturers and importers of medical devices to report to FDA whenever the manufacturer or importer has information that reasonably suggests, or a person alleges and the manufacturer or importer is aware of the allegation, that a device has caused or contributed to a death or serious injury or that a device has malfunctioned, if a recurrence of the malfunction is likely to cause or contribute to a death or serious injury. After FDA analyzes the results of its manufacturer complaint file inspection program, the agency will consider whether any reports in addition to those proposed in this rule are necessary and, if so, will propose additional reporting requirements.     

Medical devices; reclassification of polymethylmethacrylate (PMMA) bone cement. Final rule

The Food and Drug Administration (FDA) is announcing that it has reclassified the polymethylmethacrylate (PMMA) bone cement intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone from class III to class II (special controls). The agency is also announcing that it has issued an order in the form of a letter to the Orthopedic Surgical Manufacturers Association (OSMA) reclassifying the device. The special control for the device is a guidance document entitled "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement." The agency is reclassifying this device into class II because special controls, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls.     

Assignment of agency component for review of premarket applications--FDA. Final rule

The Food and Drug Administration (FDA) is promulgating a new regulation to describe how the agency will determine which component within FDA will have primary jurisdiction for the premarket review and regulation of: (1) A combination drug, device, or biologic product or (2) any drug, device, or biologic product where the center with primary jurisdiction is unclear or in dispute. This rule describes how to identify the agency's assigned review component which will, in most cases, eliminate the need for a sponsor to obtain approval from more than one FDA component for a combination product.     

General and plastic surgery devices; effective date of requirement for premarket approval of the silicone inflatable breast prosthesis. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Final rule

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the silicone inflatable breast prosthesis, a generic type of medical device intended to augment or reconstruct the female breast. This device is made of a silicone shell that is inflated with sterile isotonic saline. Commercial distribution of this device must cease unless a manufacturer or importer has filed with FDA a PMA or PDP for its version of the silicone inflatable breast prosthesis within 90 days of the effective date of this regulation. This regulation reflects FDA's exercise of its discretion to require PMA's or PDP's for preamendments devices and is consistent with FDA's stated priorities and Congress' requirement that class III devices are to be regulated by FDA's premarket review. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.     

耳内窥镜检查和录像对外伤性鼓膜穿孔的诊断意义

探讨耳内窥镜和录像检查对外伤性鼓膜穿孔的诊断意义。采用Hopkin型不同角度耳内窥镜和录像机对114例的 117只耳因头面部外伤累及到鼓膜者进行检查与分析。结果显示 :外伤性鼓膜穿孔在鼓膜的 4个象限都有发生 ,呈梭形、三角形、裂隙形、不规则形和半月形 ,其中前下象限占 6 1 91% ;非外伤性鼓膜穿孔多位于鼓膜的中央或边缘 ,呈圆形和椭圆形。耳内窥镜和录像检查可以客观真实地显示外伤性和非外伤性鼓膜穿孔的形态特征 ,能为外伤性鼓膜穿孔的法医学鉴定提供客观依据     

Effective date of requirement for premarket approval for cardiovascular permanent pacemaker electrode. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the cardiovascular permanent pacemaker electrode. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the device. This action implements certain statutory requirements.     

Early adopters of the magical thinking cap: a study on do-it-yourself (DIY) transcranial direct current stimulation (tDCS) user community

Among currently available technologies, transcranial direct current stimulation (tDCS) is one of the most promising neuroenhancements because it is relatively effective, safe, and affordable. Recently, lay people have begun to build—or purchase—the tDCS device to use it at home for treatment or as a cognitive enhancer. The tDCS device is currently not covered by the existing regulatory framework, but there are still significant potential risks of misusing this device, and its long-term effects on the brain have not been fully explored. Thus, researchers have argued the need for regulations or official guidelines for the personal use of tDCS. However, until now, no systematic research on the do-it-yourself (DIY) tDCS user community has been done. The present study explores the basic demographic characteristics of DIY tDCS users as well as why and how they are using this device through a questionnaire survey, in-depth interviews, and a content analysis of web postings on the use of tDCS. This preliminary but valuable picture of the DIY tDCS user community will shed light on future studies and policy analysis to craft sound regulations and official guidelines for the use of tDCS.     

Orthopedic devices: reclassification of the hip joint metal/polymer constrained cemented or uncemented prosthesis. Final Rule

The Food and Drug Administration (FDA) is reclassifying the hip joint metal/polymer constrained cemented or uncemented prosthesis intended to replace a hip joint from class III (premarket approval) to class II (special controls). FDA is also [[Page 21172]] identifying the guidance document entitled "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis" as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is being undertaken based on new information regarding the device contained in a reclassification petition submitted by the Orthopedic Surgical Manufacturers Association (OSMA), under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 Amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Moderization Act of 1997 (FDAMA). FDA is also revising the device identification to accurately describe the device.     

Medical devices; reports of corrections and removals--FDA. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to establish procedures for implementing the reports of corrections and removals provisions of the Safe Medical Devices Act of 1990 (the SMDA) by requiring that manufacturers, importers, and distributors report promptly to FDA any corrections or removals of a device undertaken to reduce a risk to health posed by the device or to remedy a violation of the Federal Food, Drug, and Cosmetic Act (the act) caused by the device which may present a risk to health. FDA believes that this action is necessary to protect the public health by ensuring that the agency has current and complete information regarding those actions taken to reduce risks to health caused by the devices. Reports of such actions will improve the agency's ability to evaluate device-related problems and to take prompt action against potentially dangerous devices.     

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to general redelegations of authority from the Associate Commissioner of Regulatory Affairs to certain FDA officials in the Center for Devices and Radiological Health (CDRH). The redelegation provides these officials with authority to grant or deny certain citizen petitions for exemption or variance from medical device tracking requirements. This action is being taken to facilitate expeditious handling of citizen petitions. FDA is also issuing a conforming amendment to the medical device tracking regulations to make the regulations consistent.