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TENS (Modes 1 and 6)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS (Modes 2, 3, 4 and 5)

To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

The Electrical Stimulator System delivers electric pulses to the user's body areas such as the back, neck, and foot through the electrodes. The portable and compact device has multiple modes of different pulse frequencies, including transcutaneous electrical nerve stimulation (TENS) and power muscle stimulation (PMS) that is also called Electrical Muscle Stimulation (EMS). It includes the operating elements of an ON/OFF button, intensity increase button, intensity decrease button, mode selection button, and can be attached and detached to electrodes.

The electrodes cleared include the electrode pads and electrode garments, which may be packaged separately and/or together with the subject device.

The associated accessories include: Arm Pad ( 34x56mm±2mmx2 ) * 1 Abdominal Pad(34x56mm±2mmx6) * 1 Gel Pad ( 34x56mm±2mm,produced by GMDASZ with K092546) * 8 USB Cable * 1 Operating Instruction * 1

The provided document is a 510(k) summary for an Electrical Stimulator System (K192201). It outlines the comparison of the proposed device to a predicate device and details the non-clinical tests performed to demonstrate substantial equivalence.

Based on the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate device (Electronic Pulse Stimulator, K153520) through compliance with recognized standards and comparable technical characteristics. The reported device performance is presented as its adherence to these standards and measurements of its electrical characteristics.

Here's a table summarizing the implicit acceptance criteria based on substantial equivalence and the reported performance:

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

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This means there was no "test set" in the sense of a clinical patient cohort. The tests performed were bench tests and non-clinical tests to verify that the proposed device met design specifications and was substantially equivalent to the predicate.

• Sample size: Not applicable in the context of human subjects or a clinical test set. For bench testing, sample size would refer to the number of units tested, which is not specified but would typically be a small number of devices to demonstrate consistent performance.
• Data Provenance: The tests were "bench tests" performed by the manufacturer (Gymmax Technology Shenzhen Co., Ltd. in PEOPLE'S REPUBLIC OF CHINA). The data is therefore from laboratory/engineering testing, not clinical data, and is retrospective for the purpose of the 510(k) submission.

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

Not applicable. As noted above, there was no clinical test set using human subjects to determine "ground truth" for clinical performance. The "ground truth" for substantial equivalence was established by demonstrating compliance with recognized standards and comparing technical specifications to the predicate device. This typically involves engineers and quality assurance professionals with expertise in medical device testing and regulatory compliance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as there was no clinical test set requiring human expert adjudication of results.

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

Not applicable. This device is an electrical stimulator, not an imaging analysis AI device. No MRMC study was conducted.

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

Not applicable. This device is not an algorithm for diagnostic interpretation. Its "performance" is its electrical output and safety, which was assessed in bench tests, effectively in a "standalone" manner (device operating alone without 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 submission is based on:

• Compliance with recognized industry standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993 series.
• Comparison to the predicate device's established safe and effective performance: The predicate device (K153520) serves as the benchmark for "substantial equivalence."
• Safety calculations and engineering analysis: Justification provided for differences in pulse width, maximum phase charge, and frequency range relies on calculations demonstrating continued safety within acceptable limits.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its design and performance are based on electro-mechanical principles and engineering, not machine learning.

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

Not applicable, for the same reason as point 8.

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