Catalog of Regulatory Science Tools to Help Assess New Medical Devices
This regulatory science tool is a lab method for building a 5G network testbed to assess data transmission of medical device functions using 5G connectivity.
Technical Description
Testbed as a Regulatory Science Tool (TRUST) is a design model for building 5G network testbeds (hardware, software, and mixed solutions) to assess data transmissions of medical device functions with 5G connectivity [1]. With this tool, users (e.g., medical device manufacturers, test labs) can convert their particular device testing needs into salient testbed characteristics along with recommended procedures and options to:
- plan and configure test setup profiles for replicating 5G network scenarios,
- coordinate and automate test procedures among discrete testbed components, and
- monitor and measure medical device and 5G network status for verifying the device performance through end-to-end 5G connectivity.
TRUST also identifies the minimum 5G system components needed to test a device under application-relevant scenarios and outlines how to select and customize testbed components to meet testing needs. The modular functional panels provide users with options of controlled hardware, software, and environmental configurations that enable the replication of 5G connectivity setup and verification of test results by different users at their own sites. The user can refer to the provided comparison tables to determine the features of the 5G network needed for testing and evaluate implementation options to meet target requirements on modeling accuracy of 5G connectivity profiles, test efficiency under multi-factor network conditions, and overall cost.
Intended Purpose
TRUST enables the user to design customized 5G testbeds used for evaluating performance of 5G-enabled device functions to inform medical device benefit-risk assessment. This tool outlines design considerations in testbed organization, implementation options, and customization for device-specific testing needs. This tool can help medical device innovators efficiently evaluate their emerging products and equip regulators with an approach to assess the validity of submitted evaluation data.
Testing
Tool utility was demonstrated by developing a custom, realistic 5G testbed for a specific use case involving 5G-enabled medical extended reality (MXR) [1]. In this example, a 5G testbed developed using TRUST was applied to evaluate key 5G system functions/features, verify end-to-end 5G network link configurations and capabilities, and characterize 5G-enabled medical device transmission patterns. The design model identified the key system components (entities, interfaces, and control and measurement approaches) for building a 5G testbed to evaluate the MXR device under test (DUT). An 5G user equipment (UE) setup example was illustrated for introducing the DUT’s traffic into the designed 5G testbed. The in-parallel DUT data streams were also captured and characterized with corresponding traffic patterns to assess the service transmission requirements on the emulated 5G end-to-end connection.
Limitations
- TRUST does not establish or imply acceptable medical device 5G connectivity risk.
- TRUST does not establish test acceptance criteria
- TRUST does not define device requirements or specifications for users. The designers should refer to their device specifications and corresponding evaluation needs to identify and customize the testbed profile following the general principles outlined in this tool.
- Users should verify functions of deployed network entities and interfaces (including hardware and simulated/emulated components) based on relevant 3GPP technical specifications.
- The test data presented in the TRUST demonstration for an MXR use case [2] was specific to the tested equipment and devices and should not be used to draw conclusions about the general performance and connectivity behavior of 5G networks or 5G-enabled devices.
Supporting Documentation
Full description of the 5G testbed design framework including system architecture, implementation options and principles, and the demonstration are provided in the article below:
Y. Liu and M. O. Al Kalaa, "Testbed as a RegUlatory Science Tool (TRUST): A Testbed Design for Evaluating 5G-Enabled Medical Devices," in IEEE Access, vol. 11, pp. 81563-81576, 2023, doi: 10.1109/ACCESS.2023.3299242. Details on application of TRUST to an MXR application use case can be found here:
C. Y. Cheng, Y. Liu, M. Johnson, R. M. Beams, and M. O. Al Kalaa, “Assessing 5G Connectivity in Medical Extended Reality (MXR) Applications: A Testbed Approach, “ in Proc. IEEE Healthcom’23, pp.33-38, Chongqing, China, Dec. 15-17, 2023.
Contact
Tool Reference
- In addition to citing relevant publications please reference the use of this tool using RST24ES03.1