CPS: Small: A Framework for Validation and Monitoring of Robotic Surgery Systems

医院中复杂的外科手术越来越多地由机器人手术系统辅助，通常是应患者的要求。 这些系统可以大大提高外科医生的精度、范围和灵活性。 然而，它们强大的功能在硬件和软件方面都带来了相当大的系统复杂性。 如果发生故障，严重伤害的可能性很高，这就要求对这些网络物理系统的可靠性和安全性进行严格的评估和监测。在本研究项目中，正在开发一个框架，用于评估和监测机器人手术系统在开发、现场测试和一般部署过程中的可靠性和安全性。 建议的框架补充了现有的技术在早期阶段的验证，考虑到外科医生实际上如何使用机器人手术系统，它是如何受到操作条件的影响，以及它的可观察到的行为是如何与其硬件和软件dynamics.Before部署，该框架使用精确的模拟，以评估临床前的可靠性。部署后，该框架通过在线监测系统在外地的使用情况来收集数据，然后进行分析，以评估业务的可靠性和安全性。 所收集的数据还用于改进未来测试的模拟。该框架还旨在通过为系统维护后重新评估可靠性和安全性提供可行的基础来支持这些系统的上市后监督，所开发的工具和方法也将应用于其他医疗器械的安全性和可靠性验证，包括嵌入式软件和其他网络物理系统。

Complex surgical procedures in hospitals are increasingly aided by robotic surgery systems, often at the request of patients. These systems allow greatly increased precision, reach and flexibility to the surgeon. However, their powerful capabilities entail substantial system complexity in both hardware and software. The high probability of serious injuries should a malfunction occur calls for rigorous assessment and monitoring of the reliability and safety of these cyber-physical systems.In this research project, a framework for assessing and monitoring the reliability and safety of robotic surgery systems during development, field testing, and general deployment is being developed. The proposed framework complements existing techniques used in earlier phases of validation by taking into account how surgeons actually use a robotic surgery system, how it is affected by operating conditions, and how its observable behavior is related to its hardware and software dynamics.Before deployment, this framework uses accurate simulations to assess pre-clinical reliability. After deployment, the framework uses data collection through online monitoring of the system as it is being used in the field, followed by analysis to obtain assessments of operational reliability and safety. The collected data is also used to improve the simulations for future testing. The framework also aims to support post-market surveillance of these systems by providing a workable basis for reassessing reliability and safety properties after system maintenance.The developed tools and methods will also have applications in the validation of safety and reliability of other medical devices with embedded software and other cyber-physical systems in general.