The recommended practice promotes quality management activities for datasets used for artificial intelligence medical device(AIMD). The document highlights quality objective for dataset responsible organizations. The document describes control of records during the life cycle of datasets, including but not limited to data collection, annotation, transfer, utilization, storage, maintenance, update, retirement and other activities. The document emphasizes special consideration for the dataset quality management system, including but not limited to responsibility management, resource management, dataset realization and quality control.
Working Group Details
Standard for the Performance and Safety Evaluation of Artificial Intelligence Based Medical Device: Terminology
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.