(261 days)
The MyOnyx System is intended for use as a powered muscle stimulation device for relaxation of muscle spasms and muscle re-education, prevention or retardation of disuse atrophy, maintaining or increasing range of motion, increasing local blood circulation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
The MyOnyx System may also be used for transcutaneous electrical nerve stimulation (TENS) and microcurrent electrical stimulation (MET) for the symptomatic relief of acute and chronic intractable pain.
The MyOnyx System is a multi-functional, palm-sized, 4-channel device with embedded firmware and accessories designed for use in physical therapy and rehabilitation under medical supervision. The system that is subject to this 510(k) provides pre-loaded programs and allows users to define programs for electrical muscle stimulation (EMS), transcutaneous electrical nerve stimulation (TENS), and microcurrent stimulation (MET).
Biofeedback and incontinence-related indications for use of the device have been cleared under K201014.
The device can send a gentle, clinician-adjustable electrical current to underlying nerves and muscles via off-the-shelf surface electrodes cleared by the FDA for this purpose. EMG signals may also be acquired using off-the-shelf, FDA-cleared surface EMG electrodes.
The device may be used for muscle and nerve stimulation in one of the following operating modes:
- . As a standalone device (autonomous mode); or
- . With the MyOnyx Mobile App running on an off-the-shelf tablet (remote control mode).
The device is operated via a graphical interface on an LCD screen and a capacitive touch pad with haptic and audio feedback. The connection to a tablet is wireless, via Bluetooth®. Visual, audio and voice feedback and prompts are provided to facilitate device operation.
Stimulation data are not recorded. When used in remote control mode, the device can record on the tablet root-mean-square (RMS) EMG signal data at 20 samples/s.
The device is powered by an internal rechargeable Li-ion polymer battery or via a medical grade power supply / battery charger. The internal battery offers up to 8 hours of autonomous device operation.
The MyOnyx System is a multi-functional, palm-sized, 4-channel device with embedded firmware and accessories designed for use in physical therapy and rehabilitation. It is intended for use as a powered muscle stimulation device and for transcutaneous electrical nerve stimulation (TENS) and microcurrent electrical stimulation (MET).
Here's an overview of the acceptance criteria and the study performance for the MyOnyx System:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provided details of verification and validation testing of system specifications, basic safety, and essential performance, conforming to recognized consensus standards.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Conformity to applicable basic safety and performance requirements (IEC 60601-1 / ES60601-1:2012) | Demonstrated conformity |
| EMC (Electromagnetic Compatibility) | Conformity of device emissions and device immunity to EM disturbances for use in a professional healthcare facility (IEC 60601-1-2:2014, 4th Ed.) | Demonstrated conformity |
| Basic Safety and Essential Performance of Nerve and Muscle Stimulators | Conformity of electrical stimulation programs to applicable requirements (IEC 60601-2-10:2012+A1:2016) | Demonstrated conformity |
| Basic Safety and Essential Performance of Electromyographs and Electrical Stimulators | Conformity of electrical stimulation programs to applicable requirements for accuracy of controls and protection against hazardous stimulation output (IEC 60601-2-40:2016) | Demonstrated conformity |
| Verification of Hardware Device Controls and Interfaces | Test results must meet or exceed hardware design specifications | Met or exceeded hardware design specifications |
| Usability | Conformity of the Usability Engineering Process and related outputs. Acceptance of the modified device by representative end-users operating the device as per accompanying instructions for use (IEC 60601-1-6:2010+A1:2013 in conjunction with IEC 62366-1:2015) | Demonstrated conformity and user acceptance |
| Software Life-Cycle Processes | Firmware development in conformity with requirements for Class B software ('Moderate Level of Concern') (IEC 62304:2006+A1:2015) | Demonstrated conformity |
| Stimulation Firmware Unit Testing | The device responds with expected outputs meeting software design specifications when supplied with predefined test inputs | Responded with expected outputs meeting software design specifications |
| Firmware and System-Level Functional Verification Testing | The device responds with expected outputs meeting software design specifications under anticipated use conditions and inputs | Responded with expected outputs meeting software design specifications |
| Electrical Muscle Stimulation (EMS) Parameters: | ||
| Frequency | 5 – 80 Hz, 5 Hz/step | Measured within specified range (Comparison to predicate: 1 – 150 Hz) |
| Pulse Width | 150 – 400 μs, 5 μs/step | Measured within specified range (Comparison to predicate: 50 – 300 μs) |
| Ramp-up/down | 0 – 9.9 s, 100 ms/step | Measured within specified range (Comparison to predicate: 0 – 6 s) |
| Pulse Amplitude (Output Current) | 0 – 100 mA, 1 mA/step (Regulated) | Measured within specified range (Same as predicate) |
| Max Current | 100 mA ± 20% @ 500 Ω; 39 mA ± 20% @ 2 kΩ | Measured within specified range (Comparison to predicate: 96 mA ± 20% @ 500 Ω; 105 mA ± 20% @ 1 kΩ) |
| Max Voltage | 50 Vpp ± 5% @ 500 Ω; 78 Vpp ± 5% @ 2 kΩ | Measured within specified range (Comparison to predicate: 48 Vpp ± 20% @ 500 Ω) |
| Max Charge per Pulse @500 Ω | 80 μC | Measured within specified limit (Predicate not stated) |
| Max Power Density @500 Ω | 0.027 W/cm² | Measured within specified limit (Predicate not stated) |
| Surface EMG Specifications: | ||
| EMG Accuracy | ±3% | Measured within specified accuracy |
| Transcutaneous Electrical Nerve Stimulation (TENS) Parameters: | ||
| Frequency | 2 – 150 Hz, 1 Hz/step up to 20Hz, 5 Hz/step above 20 Hz | Measured within specified range (Comparison to predicate: 1 – 150 Hz) |
| Pulse Width | 50 – 250 µs, 5 µs/step | Measured within specified range (Comparison to predicate: 50 – 300 μs) |
| Pulse Amplitude (Output Current) | 0 – 100 mA, 1 mA/step (Regulated) | Measured within specified range (Same as predicate) |
| Max Current | 100 mA ± 20% @ 500 Ω; 39 mA ± 20% @ 2 kΩ | Measured within specified range (Comparison to predicate: 96 mA ± 20% @ 500 Ω; 105 mA ± 20% @ 1 kΩ) |
| Max Voltage | 50 Vpp ± 5% @ 500 Ω; 78 Vpp ± 5% @ 2 kΩ | Measured within specified range (Comparison to predicate: 48 Vpp ± 20% @ 500 Ω) |
| Max Charge per Pulse @500 Ω | 50 µC | Measured within specified limit (Predicate not stated) |
| Max Power Density @500 Ω | 0.031 W/cm² | Measured within specified limit (Predicate not stated) |
| Microcurrent Electrical Nerve Stimulation (MET) Parameters: | ||
| Frequency | 0.5 Hz (fixed) | Measured at fixed frequency (Comparison to predicate: 1 - 150 Hz) |
| Pulse Width | 500 ms (fixed) | Measured at fixed pulse width (Comparison to predicate: 2 - 200 ms) |
| Pulse Amplitude (Output Current) | 600 µA (Regulated) | Measured at fixed amplitude (Comparison to predicate: 0 - 700 µA) |
| Max Current | 600 μA ± 20% @1 kΩ | Measured within specified range (Comparison to predicate: 760 μA ± 20% @500 Ω) |
| Max Voltage | 0.30 Vpp ± 5% @ 500 Ω | Measured within specified range (Comparison to predicate: 0.36 Vpp ± 20% @ 500 Ω) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical or performance data for AI/ML algorithms. The performance data section refers to "verification and validation testing of system specifications, basic safety and essential performance" conducted in conformance with recognized consensus standards. These are typically engineering and bench tests, not evaluations involving human subjects or clinical data in the way a diagnostic AI might be.
The provenance of data for these non-clinical tests would typically be from the manufacturer's internal testing labs. The document does not provide details on country of origin for any data or whether it was retrospective or prospective, as these are not relevant for the type of testing described (which is not a clinical study on diagnostic accuracy).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the provided document. The evaluation of the MyOnyx System primarily focused on engineering and performance standards (e.g., electrical safety, EMC, software reliability, usability) rather than clinical accuracy or diagnostic capabilities requiring expert-established ground truth. No experts for ground truth establishment are mentioned.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used in clinical studies or studies evaluating the accuracy of AI algorithms against a reference standard with human expert disagreement. The tests described are engineering validations against predefined specifications and regulatory standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence for this device type. The clinical literature supports the safety and clinical utility of the stimulation modes for the stated indications for use." Therefore, an MRMC comparative effectiveness study was not conducted or reported.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, in essence, the majority of the reported "Performance Data" represents a standalone evaluation of the device's technical specifications and compliance with standards. The tests such as "Electrical safety," "EMC," "Basic safety and essential performance of nerve and muscle stimulators," "Verification of hardware device controls and interfaces," "Software life-cycle processes," and "Stimulation firmware unit testing" are all evaluations of the device's inherent performance as an algorithm-driven system or hardware.
The usability testing (IEC 60601-1-6 / IEC 62366-1) involves human interaction but evaluates the device's interface and the safety of that interaction, not the diagnostic or therapeutic performance in a "human-in-the-loop" clinical decision-making context with an AI.
7. The Type of Ground Truth Used
For the engineering and performance tests, the "ground truth" is defined by the technical specifications outlined in the relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2) and the internal hardware and software design specifications of the MyOnyx System. The device's outputs and functionalities are measured and compared against these established technical criteria and limits.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of AI/ML or a clinical study. The device contains "embedded firmware" and "pre-loaded programs," which implies pre-determined algorithms and settings rather than adaptive AI models that undergo continuous training with a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no mention of a "training set" for an AI/ML algorithm within the provided document. The device uses pre-programmed logic for its stimulation modes.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).