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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:

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.

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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

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.

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The Medic4All Telemedicine System Model VMS-01 is intended to collect and transmit physiological information, such as glucose levels, 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.

Here's an analysis of the provided 510(k) submission for the Medic4All Telemedicine System VMS-01, focusing on acceptance criteria and study data:

Acceptance Criteria and Device Performance for Medic4All Telemedicine System VMS-01

Based on the provided K061502 510(k) summary, the device is a telemedicine system for collecting and transmitting physiological information. The performance data focuses on the functional integrity and reliability of the system rather than clinical efficacy or accuracy in diagnosing specific conditions.

1. Table of Acceptance Criteria and Reported Device Performance

It is important to note: The provided document does not specify quantifiable acceptance criteria (e.g., "data transmission success rate > 99%") or detailed performance metrics. The statement "In all instances, the VMS-01 functioned as intended" serves as the general reported performance against implied criteria for each test category.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective). The descriptions are general statements about various types of "verification and validation testing activities."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The provided document does not mention using experts to establish ground truth for a test set. The validation activities described (EMC/Electrical Safety, unit testing, integration testing, etc.) are engineering and system validation tests, not clinical performance studies requiring expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

As no expert adjudication for a clinical test set is mentioned, there is no adjudication method described.

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 improve with AI vs without AI assistance

No MRMC comparative effectiveness study (human readers with/without AI assistance) was conducted or reported in this 510(k) submission. This is a telemedicine system for data transmission, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The "performance data" section describes standalone functional testing of the system components and the whole system (e.g., unit testing, integration testing, data integrity testing, load/performance testing). This is algorithm-only in the sense that the system's technical operation was evaluated independently. However, it's not a standalone clinical performance study in the way it might be for a diagnostic AI.

7. The Type of Ground Truth Used

For the functional and reliability testing described (EMC/Electrical Safety, unit, integration, data integrity, usability, environmental, compatibility, performance, system, load/performance testing), the "ground truth" would be established by:

• Engineering specifications and design documents: Whether the system outputs match expected values, whether data is transmitted without corruption, whether modules integrate correctly.
• Standards compliance: For EMC/Electrical Safety, testing against industry and regulatory standards.
• User feedback/defined requirements: For usability testing, whether the system meets pre-defined usability criteria.

It is not clinical ground truth like expert consensus, pathology, or outcomes data, as this device primarily focuses on data collection and transmission functionality.

8. The Sample Size for the Training Set

This device is not an AI/machine learning model that requires a "training set" in the typical sense. It is a telemedicine system composed of hardware and software components. Therefore, no training set sample size is applicable or mentioned.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

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