Cha Jackie S, Fuller Patrick, Ball Matthew, Samreen Sarah, Sylla Patricia, Stefanidis Dimitrios
Department of Industrial Engineering, Clemson University, Clemson, SC, USA.
Department of Industrial & Systems Engineering, University of Wisconsin - Madison, Madison, WI, USA.
Surg Endosc. 2025 Jul 17. doi: 10.1007/s00464-025-11897-w.
Robotic-assisted surgery (RAS) has transformed surgical practice, offering improved ergonomics, enhanced visualization, and improved dexterity. However, as new RAS technology and systems are developed, stakeholders including surgeons, hospital administrators, and regulators face challenges in evaluating system features and selecting appropriate platforms. Thus, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Robotics Committee aimed to develop a tool for assessing robotic surgery systems.
Using a literature review and iterative feedback from SAGES robotic committee members, the relevant categories and corresponding specific metrics for evaluation of RAS systems were first defined. The final tool included categories and metrics agreed upon by > 80% of committee members. To determine the applicability and usability of this tool, the tool was applied to the evaluation of FDA-cleared robotic systems in the US and any needed changes were implemented.
The SAGES Tool for Assessing Robotic Surgery Systems (STARSS) that is a structured evaluation framework designed to facilitate the comparison of RAS systems was developed. The tool includes metrics spanning seven categories: General Information, Software Information, Hardware Information, Usability, Safety Features, Ergonomic Capabilities, and Training and Certification. Its application to Food and Drug Administration (FDA)-cleared RAS platforms is presented.
STARSS enables systematic comparison of RAS systems by capturing technical capabilities, workflow integration, safety considerations, ergonomic support, and training infrastructure. It highlights both strengths and gaps in current platforms and can help guide clinical adoption, procurement decisions, research, and future system development.
机器人辅助手术(RAS)已经改变了外科手术实践,提供了更好的人体工程学设计、增强的可视化效果以及更高的灵活性。然而,随着新的RAS技术和系统不断发展,包括外科医生、医院管理人员和监管机构在内的利益相关者在评估系统功能和选择合适平台时面临挑战。因此,美国胃肠和内镜外科医师协会(SAGES)机器人委员会旨在开发一种评估机器人手术系统的工具。
通过文献综述以及SAGES机器人委员会成员的反复反馈,首先定义了评估RAS系统的相关类别和相应的具体指标。最终工具包含了超过80%的委员会成员认可的类别和指标。为了确定该工具的适用性和实用性,将其应用于对美国食品药品监督管理局(FDA)批准的机器人系统的评估,并进行了任何必要的修改。
开发了SAGES机器人手术系统评估工具(STARSS),这是一个结构化的评估框架,旨在促进RAS系统的比较。该工具包括涵盖七个类别的指标:一般信息、软件信息、硬件信息、可用性、安全功能、人体工程学能力以及培训和认证。展示了其在食品药品监督管理局(FDA)批准的RAS平台上的应用。
STARSS通过获取技术能力、工作流程整合、安全考量、人体工程学支持和培训基础设施,能够对RAS系统进行系统比较。它突出了当前平台的优势与不足,有助于指导临床应用、采购决策、研究以及未来系统开发。