(106 days)
The Medic4All Telemedicine System Model VMS-01 is intended to collect and transmit physiological information, such as non-invasive blood pressure, 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 provided text describes the "Medic4All Telemedicine System VMS-01" in the context of a 510(k) submission to the FDA. However, it does not include detailed acceptance criteria or a specific study proving the device meets quantitative performance metrics.
Instead, the document focuses on:
- Substantial Equivalence: Comparing the VMS-01 to predicate devices (Philips Medical Systems M3810A TeleMonitoring System and BL-Healthcare, Inc. Remote Care Management System) for intended use, indications, technological characteristics, and principles of operation.
- Performance Data (General): A general statement that "Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the telemedicine system. Testing involved EMC/Electrical safety; unit testing; integration testing; data integrity testing; usability testing; environmental testing; compatibility testing; performance testing, system testing, and load/performance testing for the whole telemedicine system. In all instances, the VMS-01 functioned as intended."
Therefore, many of the requested details about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, and expert involvement are not available in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific quantitative criteria not provided in the document. | "In all instances, the VMS-01 functioned as intended" for various testing activities (EMC/Electrical safety, unit testing, integration testing, data integrity testing, usability testing, environmental testing, compatibility testing, performance testing, system testing, and load/performance testing). |
Explanation: The document states that performance testing was conducted and the device "functioned as intended," but it does not specify what those "intentions" or quantitative criteria were (e.g., specific accuracy levels for blood pressure measurements, data transmission reliability percentages, etc.).
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set
- Adjudication method: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- MRMC study done: No. The device is a telemedicine system for collecting and transmitting physiological information, not an imaging device typically subject to MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone study done: The performance testing mentioned ("unit testing; integration testing; data integrity testing; usability testing; environmental testing; compatibility testing; performance testing, system testing, and load/performance testing") would likely encompass standalone performance aspects. However, a dedicated "standalone performance" study in the context of an AI algorithm is not explicitly detailed, nor is there mention of a specific algorithm (beyond a general "telemedicine system"). The device's primary function is data collection and transmission.
7. The type of ground truth used
- Type of ground truth: Not specified. For a system that collects physiological information like non-invasive blood pressure, the "ground truth" would typically refer to the accuracy of the measurements compared to a reference standard, or the reliability of data transmission. The document only generally mentions "data integrity testing" and "performance testing."
8. The sample size for the training set
- Sample size for training set: Not applicable based on the information provided. The VMS-01 is described as a telemedicine system for data collection and transmission, not an AI/machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- How ground truth for training set was established: Not applicable, as there's no mention of a training set for an AI/ML algorithm.
§ 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).