(75 days)
The Medic4All Telemedicine System Model VMS-01 is intended to collect and transmit physiological information, such as weight, via standard telephone lines or the internet to local or remote computer systems for use by the patient or a healthcare professional.
Medic4All's VMS-01 telemedicine system (VMS-01) is a wireless telephonic/internet-based physiologic monitoring system, designed for care of patients requiring periodic monitoring. It is designed for interactive, remote, physiological data measurement, transmission, processing, storage and display of data. Additionally, the system allows optional verbal and video conferencing between a care giver and a patient through common telephone lines or the internet and optional hardware.
The Medic4All Telemedicine System VMS-01 is a device intended to collect and transmit physiological information, such as weight, via standard telephone lines or the Internet to local or remote computer systems for use by the patient or a healthcare professional.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| EMC/Electrical Safety | Functioned as intended | |
| Unit Testing | Functioned as intended | |
| Integration Testing | Functioned as intended | |
| Data Integrity Testing | Functioned as intended | |
| Usability Testing | Functioned as intended | |
| Environmental Testing | Functioned as intended | |
| Compatibility Testing | Functioned as intended | |
| Performance Testing | Functioned as intended | |
| System Testing | Functioned as intended | |
| Load/Performance Testing | Functioned as intended |
2. Sample size used for the test set and the data provenance:
The provided 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for any of the performance tests. The document broadly states "Verification and validation testing activities were conducted."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the 510(k) summary. The device's primary function is data collection and transmission, not diagnostic interpretation that would typically require expert ground truth.
4. Adjudication method for the test set:
This information is not provided in the 510(k) summary. Given the nature of the device (data collection and transmission), adjudication methods typically associated with diagnostic image or signal interpretation are unlikely to be relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improved with AI vs without AI assistance:
A multi-reader multi-case (MRMC) comparative effectiveness study was not applicable and not done. This device is a telemedicine system for data transmission and does not involve AI for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone performance evaluation of the "algorithm" (the system's functionality) was conducted. The document states "In all instances, the VMS-01 functioned as intended" for various tests including unit testing, integration testing, data integrity testing, and performance testing. This suggests the system itself was evaluated for its ability to perform its stated functions independent of a human interpreting its output for diagnostic purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device would be its ability to accurately collect and transmit physiological information. For instance, for "data integrity testing," the ground truth would be that the transmitted data matches the collected data without alteration or loss. For "performance testing," it would be that the system operates within expected parameters (e.g., speed, reliability). The document does not specify the exact methods for establishing this ground truth for each test category, but it implies direct verification of the system's operational correctness.
8. The sample size for the training set:
This information is not provided. The VMS-01 is described as a "wireless telephonic/internet-based physiologic monitoring system" and its design focuses on data measurement, transmission, processing, storage, and display. There is no indication of machine learning or AI components that would typically require a training set in the context of diagnostic interpretation.
9. How the ground truth for the training set was established:
This information is not provided and is likely not relevant, as there is no mention of a "training set" in the context of machine learning or AI for diagnostic purposes for this device.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).