Abstract: Artificial intelligence is a blooming branch of medical device. Its development and quality control all rely on high quality clinical data. Since there is no established standard or guidance yet, it is important to study how to build and utilize a dataset appropriately and scientifically, especially for the decrease of clinical trial expense. With reference to the current status of premarket review and related guidance in developed countries, this paper analyzes the role and requirement of datasets in the quality control of AI medical device, providing useful information for regulation agencies and the development of public datasets for AI.