Standardization for Summative Usability Testing of Surgical Robots

Summative usability testing is a crucial step in ensuring the safety and usability of robotic-assisted surgical devices and considered as part of premarket verification and validation. Its standardized implementation relies on the coordinated support of the "test plan-test process" framework. With reference to general standards, this paper focuses on the summative usability testing of such devices, systematically analyzing core elements and experimental rationale during the test. In terms of test plan, this paper discusses particular issue with risk management and pass criteria according to clinical application scenario of robotic-assisted surgical devices, which follows medical device registration requirement. This paper provides technical support for the standardized implementation of summative usability testing for such devices, help reduce product launch risks, and promote the high-quality development of the industry.