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The PBI MyoVision 3G WireFree™ Systems are indicated to provide the clinician with EMG activity, skin temperature, angles of the patient's motion information during therapies that include muscle relaxation training and re-education.

The MyoVision 3G WireFree™ System consists of handheld scanner devices which receive and transmit signals to a system hub. The data from the devices is displayed on a personal computer.
The MyoVision 3G WireFree™ System is designed to measure and visually present physiological signals corresponding to muscle activity (surface EMG), range of motion, and maps of heat generated by the human body. This device is intended to provide the clinician with a patient's EMG activity, skin temperature, and range of motion during therapies that include muscle relaxation training and re-education.
The MyoVision 3G WireFree™ System consists of four (4) physiological parameter scanners, a system hub, and proprietary application software. The four scanners are the
static surface EMG scanners (ScanVision™),
dynamic surface EMG scanner (DynaVision™),
range of motion inclinometers (FlexVision™), and
thermograph (ThermoVision™).
Data collected by the scanners is wirelessly transmitted to a computer via a system hub (either SoloVision™ or PhysioMonitor™) for data processing, data storage, and visual display. The wireless feature provides for data collection efficiency and ease of use. The proprietary application software was developed and validated by Precision Biometrics, Inc. (PBI).

The provided document (K123399) by Precision Biometrics Inc. for their MyoVision 3G WireFree™ System does not include acceptance criteria or a study that directly proves device performance against specific acceptance criteria in the manner typically seen for AI/ML-enabled devices.

This submission is a 510(k) Premarket Notification for a diagnostic electromyography device, which relies on demonstrating substantial equivalence to a legally marketed predicate device (Fasstech, Insight Millennium III (K023209)). The summary focuses on technological character differences and non-clinical performance data to support this equivalence.

Here's an analysis based on the information provided, specifically addressing the questions concerning acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail metrics for device performance in the document. The submission focuses on compliance with established standards (like those from AAMI, IEC, ISO) and demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: Instead of specific performance metrics against acceptance criteria, the document states: "Performance testing per standardized methods and PBI test protocols for bench data was conducted and provides support that the MyoVision 3G WireFree™ System is substantially equivalent to currently marketed predicate devices." And "Non-clinical performance test protocols and results demonstrate that, in consideration of its intended use, the design, labeling, and packaging of the MyoVision 3G WireFree™ System is compliant with all applicable standards."
  • No numerical performance data (e.g., accuracy, sensitivity, specificity, or error rates) are reported for the device's functions (EMG activity, skin temperature, range of motion).

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not applicable or not reported. The document describes "bench data" and "non-clinical performance test protocols," implying testing was conducted on the device hardware and software against standards, not on a clinical test set of patient data.
• Data Provenance: Not applicable, as there's no mention of a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. There is no mention of a human-adjudicated test set or ground truth established by experts.

4. Adjudication method for the test set

• Not applicable. No test set requiring adjudication is mentioned.

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. This device is an electromyography, range of motion, and thermography system that measures physiological signals directly. It's not an AI/ML-enabled device designed to assist human readers in interpreting complex images or data in a comparative effectiveness study scenario.

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

• Not explicitly stated for an "algorithm only" performance because the device's function is to collect and display physiological signals. Its performance is measured by the accuracy and reliability of these measurements against established standards, not by an algorithm's classification accuracy. The "proprietary application software" was "developed and validated by Precision Biometrics, Inc.," but details of this validation are not provided in terms of standalone performance metrics.

7. The type of ground truth used

• For the non-clinical performance, the "ground truth" would be established by the specifications and measurement ranges defined by the standards (e.g., ANSI/AAMI EC12:2006 for ECG electrodes, IEC 60601-1 for safety and essential performance, IEC 60601-2-40 for electromyographs). The device's measurements would be compared against these standard requirements, rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set of data.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/ML device that requires a training set of data with established ground truth.

Summary of the Study:
The study described is a set of non-clinical performance tests conducted per standardized methods and PBI test protocols for bench data. These tests aimed to demonstrate that the MyoVision 3G WireFree™ System (hardware and software combined for signal acquisition and display) is compliant with applicable standards (e.g., ANSI/AAMI, IEC, ISO) and is substantially equivalent to the predicate device (Fasstech, Insight Millennium III). The document explicitly states, "Clinical data was not necessary to support that the MyoVision 3G WireFree™ System is substantially equivalent to the currently marketed predicate device."

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