Clinical Performance Assessment Guidance

FDA has published a guidance, Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions, with recommendations for industry, systems and service providers, consultants, agency staff, and others on clinical performance assessment of computer-assisted detection (CADe) devices applied to radiology images and radiology device data. The document says that CADe devices are computerized systems that incorporate pattern recognition and data analysis capabilities intended to identify, mark, highlight, or in any other manner direct attention to portions of an image, or aspects of radiology device data, that may reveal abnormalities during interpretation of patient radiology images or patient radiology data by the intended user.

The guidance contains an Introduction, Scope, Rationale, Clinical Study Design, Study Population, Reference Standard, Reporting, and Appendix.