Toward standardized premarket evaluation of computer aided diagnosis/detection products: insights from FDA-approved...

Computer aided detection and diagnosis (CADe and CADx) products are an emerging branch of medical device industry. However, limited technical standard has been developed for product verification and validation. It will be helpful to investigate the current practice of preclinical and clinical evaluation of approved products and provide insights for future standardization.

Document review was conducted on 56 products approved by the United States Food and Drug Administration, including Summary of Safety and Effectiveness Data, 510(k) decision and de novo decision summaries. Key parameters describing product characteristics, preclinical studies and clinical studies were collected. Evaluation strategies for CADe/CADx products were analyzed and assessed.

Preclinical studies were widely adopted in the verification of CADe/CADx products. Standalone performance testing was a common procedure, but the selection of testing dataset and performance metrics showed significant variability and flexibility among manufacturers. Clinical studies were reported by all class III products and some class II products, and Multi-Reader Multi-Case design was commonly used. However, statistical analysis and presentation/interpretation of results was oftentimes incomplete. To resolve above issues, systematic development of standards of CADe/CADx is encouraged, which can be implemented at different aspects through the product lifecycle.