Performance evaluation methods for improvements at post-market of artificial intelligence/machine learning-based computer-aided detection/diagnosis/triage in the United States.

Computer-aided detection (CADe), computer-aided diagnosis (CADx), and computer-aided simple triage (CAST), which incorporate artificial intelligence (AI) and machine learning (ML), are continually undergoing post-market improvement. Therefore, understanding the evaluation and approval process of improved products is important. This study intended to conduct a comprehensive survey of AI/ML-based CAD products approved by the U.

Systematic analysis of the test design and performance of AI/ML-based medical devices approved for triage/detection/diagnosis in the USA and Japan.

The development of computer-aided detection (CAD) using artificial intelligence (AI) and machine learning (ML) is rapidly evolving. Submission of AI/ML-based CAD devices for regulatory approval requires information about clinical trial design and performance criteria, but the requirements vary between countries. This study compares the requirements for AI/ML-based CAD devices approved by the US Food and Drug Administration (FDA) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.