P2802 - Standard for the Performance and Safety Evaluation of Artificial Intelligence Based Medical Device: Terminology
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The standard establishes terminology used in artificial intelligence medical device, including definitions of fundamental concepts and methodology that describe the safety, effectiveness, risks and quality management of artificial intelligence medical device. The standard provides definitions using the following forms, such as but not limited to literal description, equations, tables, figures and legends. The standard also establishes a vocabulary for the development of future standards for artificial intelligence medical device.
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