Evidence map›Paper›PMID 37691998›Full record

ArticleIEEE access : practical innovations, open solutions2023

Testbed as a RegUlatory Science Tool (TRUST): A Testbed Design for Evaluating 5G-Enabled Medical Devices.

Yongkang Liu, Mohamad Omar Al Kalaa

Abstract read
In one paragraph

Article in IEEE access : practical innovations, open solutions, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Yongkang LiuOffice of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration, Silver Spring, MD, USA.
Mohamad Omar Al KalaaOffice of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration, Silver Spring, MD, USA.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

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.

Indexed as

5G mobile communicationbiomedical equipmentBiomedical informationtesting

Identifiers

PMID37691998
PMCPMC10483486

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.