摘要
目的分析内窥镜手术机器人软件的临床风险,研究相应安全有效性评价方法和评价要点。方法结合多个产品的审评经验,按照软件模块进行风险分析,围绕主从运动控制进行性能评价,从人机交互角度进行性能评估。结果得出产品在运动控制、图像处理、手术器械控制、安全措施、网络安全、人工智能及辅助决策6个方面的评价要点。结论手术机器人软件的安全有效性评价应遵从风险管理的思路,按照医疗器械安全和性能基本要求,立足于产品现阶段实际制定评价方法和评价标准。评价方法和要点可以为产品研发、注册和技术审评工作提供参考。
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.
作者
张晨光
陈敏
ZHANG Chenguang;CHEN Min(Center for Medical Device Evaluation,NMPA,Beijing 100081,China)
出处
《中国医疗设备》
2022年第9期14-18,共5页
China Medical Devices
基金
国家重点研发计划(2019YFB1311504)。
关键词
手术机器人软件
性能要求
非临床研究
评价要点
surgical robot software
performance research
non-clinical studies
evaluation key points
