Clinical Performance Assessment: Considerations for CADe Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions
On 22nd January 2020, FDA published a guidance for premarket approval (PMA) and premarket notification (510(k)) submissions for Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data.
This guidance document provides recommendations regarding clinical performance assessment of computer-assisted detection (CADe) devices applied to radiology images and radiology device data. 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 device data by the intended user.