Liu Yongkang, Al Kalaa Mohamad Omar
Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration, Silver Spring, MD, USA.
IEEE Access. 2023;11:81563-81576. doi: 10.1109/access.2023.3299242.
The fifth-generation (5G) cellular communication technology introduces technical advances that can expand medical device access to connectivity services. However, assessing the safety and effectiveness of emerging 5G-enabled medical devices is challenging as relevant evaluation methods have not yet been established. In this paper, we propose a design model for 5G testbed as a regulatory science tool (TRUST) for assessing 5G connectivity enablers of medical device functions. Specifically, we first identify application specific testing needs and general testing protocols. Next, we outline the selection and customization of key system components to create a 5G testbed. A TRUST demonstration is documented through a realistic 5G testbed implementation along with the deployment of a custom-built example use-case for 5G-enabled medical extended reality (MXR). Detailed configurations, example collected data, and implementation challenges are presented. The openness of the TRUST design model allows a TRUST testbed to be easily extended and customized to incorporate available resources and address the evaluation needs of different stakeholders.
第五代（5G）蜂窝通信技术带来了技术进步，可扩大医疗设备对连接服务的接入。然而，评估新兴的支持5G的医疗设备的安全性和有效性具有挑战性，因为相关评估方法尚未建立。在本文中，我们提出了一种5G测试平台的设计模型，作为评估医疗设备功能的5G连接支持因素的监管科学工具（TRUST）。具体而言，我们首先确定特定应用的测试需求和通用测试协议。接下来，我们概述关键系统组件的选择和定制，以创建一个5G测试平台。通过一个实际的5G测试平台实施以及为支持5G的医疗扩展现实（MXR）部署一个定制的示例用例，记录了TRUST演示。展示了详细配置、示例收集数据和实施挑战。TRUST设计模型的开放性使TRUST测试平台能够轻松扩展和定制，以整合可用资源并满足不同利益相关者的评估需求。
