Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions

This guidance document provides FDA’s recommendations on clinical performance assessments to support premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices applied to radiology images and radiology device data. This guidance applies to CADe devices, including when a CADe device is part of a combined system, such as the detection portion of combined computer-aided detection and diagnostic devices. The recommendations are intended to promote consistency and facilitate efficient review of clinical performance assessments in CADe 510(k) submissions.