Code of Federal Regulations Title 21. Food and Drugs § 21.892.2070 Medical image analyzer

(i) A detailed description of the image analysis algorithms including a description of the algorithm inputs and outputs, each major component or block, and algorithm limitations.

(ii) A detailed description of pre-specified performance testing methods and dataset(s) used to assess whether the device will improve reader performance as intended and to characterize the standalone device performance. Performance testing includes one or more standalone tests, side-by-side comparisons, or a reader study, as applicable.

(iii) Results from performance testing that demonstrate that the device improves reader performance in the intended use population when used in accordance with the instructions for use. The performance assessment must be based on appropriate diagnostic accuracy measures (e.g., receiver operator characteristic plot, sensitivity, specificity, predictive value, and diagnostic likelihood ratio). The test dataset must contain a sufficient number of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, concomitant diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and imaging equipment.

(iv) Appropriate software documentation (e.g., device hazard analysis;  software requirements specification document;  software design specification document;  traceability analysis;  description of verification and validation activities including system level test protocol, pass/fail criteria, and results;  and cybersecurity).

(i) A detailed description of the patient population for which the device is indicated for use.

(ii) A detailed description of the intended reading protocol.

(iii) A detailed description of the intended user and user training that addresses appropriate reading protocols for the device.

(iv) A detailed description of the device inputs and outputs.

(v) A detailed description of compatible imaging hardware and imaging protocols.

(vi) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (e.g., poor image quality or for certain subpopulations), as applicable.

(vii) Device operating instructions.

(viii) A detailed summary of the performance testing, including:  test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.