Division of Imaging and Applied Mathematics, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD 20993-0002, USA.
Acad Radiol. 2012 Apr;19(4):463-77. doi: 10.1016/j.acra.2011.12.016. Epub 2012 Feb 3.
This report summarizes the Joint FDA-MIPS Workshop on Methods for the Evaluation of Imaging and Computer-Assist Devices. The purpose of the workshop was to gather information on the current state of the science and facilitate consensus development on statistical methods and study designs for the evaluation of imaging devices to support US Food and Drug Administration submissions. Additionally, participants expected to identify gaps in knowledge and unmet needs that should be addressed in future research. This summary is intended to document the topics that were discussed at the meeting and disseminate the lessons that have been learned through past studies of imaging and computer-aided detection and diagnosis device performance.
本报告总结了 FDA-MIPS 联合成像和计算机辅助设备评估方法研讨会。研讨会的目的是收集有关科学现状的信息，并促进统计方法和研究设计方面的共识制定，以支持美国食品和药物管理局的提交。此外，参与者预计将确定知识差距和未满足的需求，这些需求应在未来的研究中得到解决。本总结旨在记录会议讨论的主题，并传播通过过去对成像和计算机辅助检测和诊断设备性能的研究中获得的经验教训。
