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Powered Muscle Stimulator

• · To temporarily increase local blood circulation in healthy leg muscles.
• · To stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS

• · For temporary relief of pain associated with sore and aching muscles in the lower extremities (legs) due to strain from exercise, normal household duties and work activities.

The FlowKeepers® is a portable, battery powered device and delivers electrical stimulation through the skin to the muscles. It provides low frequency (0.1 Hz) muscle stimulation with rectangular, bipolar, biphasic pulses, and operates in a range which balances between comfort and effective contractions. There is a control unit with power buttons and LED flasher.

The provided text describes a 510(k) premarket notification for the FlowKeepers® device, a powered muscle stimulator. The FDA's review assesses substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of quantitative acceptance criteria that the device must meet in terms of performance metrics (like sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance testing" section describes compliance with electrical and safety standards, rather than clinical performance metrics.

The comparison table provided (pages 5-6) highlights the technological characteristics of the FlowKeepers® and its predicate devices, implying that similarity in these characteristics, combined with compliance to safety standards, is the basis for acceptance.

| Feature / Standard | Acceptance Criteria (Implied by Predicate Equivalence & Standards) | Reported Device Performance (FlowKeepers®) |
|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indications for Use (Powered Muscle Stimulator) | Temporarily increase local blood circulation in healthy leg muscles; Stimulate healthy muscles to improve/facilitate muscle performance. | Meets these indications. |
| Intended Use/Indications for Use (TENS) | Temporary relief of pain associated with sore and aching muscles in the lower extremities (legs) due to strain from exercise, normal household duties, and work activities. | Meets these indications. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Edition 3: 2007-03. | "functioned as intended and the results observed were as expected." |
| Electrical Safety (General) | Compliance with IEC 60601-1-8:2006 & A1:2012. | "functioned as intended and the results observed were as expected." |
| Electrical Safety (Home Healthcare Environment) | Compliance with IEC 60601-1-11 Edition 1.0 2010-04. | "functioned as intended and the results observed were as expected." |
| Electrical Safety (Programmable Systems) | Compliance with IEC 60601-1-4. | "functioned as intended and the results observed were as expected." |
| Electrical Safety (Nerve and Muscle Stimulators) | Compliance with IEC 60601-2-10 Edition 2.0 2012-06. | "functioned as intended and the results observed were as expected." |
| Waveform | Similar to predicate (Pulsed symmetrical biphasic and bipolar). | Pulsed symmetrical biphasic and bipolar. |
| Max Output Voltage, Current, Pulse Duration, Frequency, Net Charge, Max Phase Charge, Current Density, Power Density | Parameters within acceptable range to not adversely impact safety or effectiveness, similar to other cleared devices (K160508). | Max output voltage: 166V@500Ω, 252V@2kΩ, 290V@10kΩ. Max output current: 332mA@500Ω, 126mA@2kΩ, 29mA@10kΩ. Pulse Duration: 150 µs +150 µs ±10%. Frequency: 100mHz ±10%. Net Charge per Pulse: 0 @500Ω. Maximum Phase Charge: 2.25 @500Ω. Maximum Current Density: 0.789 mA/cm²@500Ω. Maximum Power Density: 0.00177 mW/cm²@ 500Ω. |

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

The document does not describe a test set or clinical study with human subjects for evaluating the FlowKeepers® device's effectiveness in terms of its stated indications (e.g., increasing local blood circulation, stimulating muscles, or pain relief).

The "Performance Testing" section refers to non-clinical tests (Electromagnetic compatibility, electrical safety, and other performance testing) conducted in accordance with specified IEC standards. These are likely bench tests and laboratory evaluations rather than tests on human subjects.

Therefore:

• Sample size for test set: Not applicable, as no human subject test set is described for performance evaluation.
• Data provenance: Not applicable. The data provenance would be from laboratory/bench testing, not patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Since no human clinical data is presented for performance evaluation, there is no need for experts to establish ground truth for a test set. The validation is against engineering and safety standards.

4. Adjudication Method for the Test Set:

Not applicable, as no human clinical test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document explicitly states "non-clinical tests" were conducted. There is no mention of a clinical study, an MRMC study, or any comparison of human readers with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

No. The FlowKeepers® is a physical medical device (powered muscle stimulator), not an algorithm or AI. The performance testing revolves around the device's adherence to electrical and safety standards.

7. Type of Ground Truth Used:

The ground truth used for the "performance testing" described are the specifications and requirements defined within the cited IEC and UL standards (e.g., limits for electromagnetic emissions, electrical safety parameters, performance under various environmental conditions). The device passed these technical standards.

For demonstrating substantial equivalence, the "ground truth" is the performance and safety profile of the predicate devices, which the FlowKeepers® is compared to technologically.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that would require a "training set." The testing described is for a hardware device.

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

Not applicable. No training set is involved.

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