Clinical Evaluation of AI-Based Medical Devices

Artificial intelligence (AI) medical devices have high potential value in clinical applications and have received widespread attention from society. However, the history of design development and the clinical application of such products is relatively short, and manufacturers have less experience in registration and less understanding of clinical evaluation requirements. Even in some aspects, there are certain misunderstandings. By summarizing the international and domestic pre-market clinical evaluation requirements and experience, this chapter analyzes the design elements and bias control methods to provide suggestions and ideas for manufacturers to conduct a clinical evaluation scientifically.