Abstract:Objective To analyze the clinical risks of robot software for endoscopic surgery, and study the corresponding safety and
effectiveness evaluation methods and evaluation key points. Methods Combined with the review experience of multiple applied
products, risk analysis according to software modules, performance evaluation was carried out around master-slave motion control,
and performance evaluation from the perspective of human-computer interaction. Results The evaluation key points of the product in
six aspects were given, including motion control, image processing, surgical instrument control, safety measures, network security,
artificial intelligence and decision-making assistance. Conclusion The safety and effectiveness evaluation of surgical robot software
should follow the idea of risk management, according to the basic principles of medical device safety and performance, and based on
the actual product current stage to formulate evaluation methods and evaluation standards. The evaluation methods and key points
can provide reference for product development, registration and technical review.
张晨光,陈敏. 内窥镜手术机器人软件安全有效性评价要点的探讨[J]. 中国医疗设备, 2022, 37(9): 14-18.
ZHANG Chenguang, CHEN Min. Discussion on Key Points of Safety and Effectiveness Evaluation of
Endoscopic Surgical Robot Software. China Medical Devices, 2022, 37(9): 14-18.