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The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities and for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The Healy device is a single channel wearable electrotherapy device that is designed to alleviate temporary and chronic muscle and joint pain on multiple body locations. It delivers microcurrent therapy through the simple and convenient use of the dedicated iOS or Android App, or on product controls. Reusable, selfadhesive and contouring electrodes allow for discreet and convenient placement on multiple pain locations on the body. The system contains one unit, which is rechargeable and is attached to the electrode via cables. The electrode can then be applied to intact skin at the desired location for therapy and pain relief. Control of the Healy system is completed through the available App or on product controls.

The provided text is a 510(k) summary for the Healy device, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Omron Avail, Model PM601, K172079) rather than providing detailed acceptance criteria and a study proving the device meets those criteria.

However, based on the information provided, we can infer some details related to acceptance criteria and the underlying studies.

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

The document doesn't present a specific table of acceptance criteria with corresponding performance metrics like a typical clinical trial report. Instead, it relies on demonstrating equivalence to a predicate device by comparing various technological characteristics and performance parameters. The "acceptance criteria" can be interpreted as demonstrating that the device's characteristics are either "No Difference", "Similar", or if different, that the differences "do not raise new questions of safety or effectiveness" when compared to the predicate device.

Here's an aggregated summary table based on the "Substantial Equivalence Comparison Table" and "Output Comparison" in the provided text. The "Acceptance Criteria" column reflects the implicit criteria used for substantial equivalence, i.e., that the device characteristics should be comparable to the predicate. The "Reported Device Performance" is the value for the Healy device. The "Outcome/Compliance" indicates whether the Healy device was found to be acceptable in comparison to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe any clinical study with a "test set" in the context of typical AI/software performance validation involving human data. The submission is a 510(k) for a TENS device, and the "performance data" section states, "All necessary non-clinical testing was conducted on the Healy device to confirm that the device performs as intended." This primarily refers to bench testing, electrical safety, EMC, and software validation.

Therefore, there is:

• No reported sample size for a test set.
• No clinical data provenance (country of origin, retrospective/prospective).

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

Not applicable. As no clinical "test set" based on human data or expert review was used for performance evaluation, no experts were needed to establish ground truth. The evaluation focused on engineering and software validation.

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

Not applicable. No expert-adjudicated test set was used.

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 is not an AI/imaging device. The Healy device is a transcutaneous electrical nerve stimulator, and the submission does not mention any AI component or human reader assistance.

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

This question is typically relevant for AI/software devices. The "standalone" performance here relates to the device's physical and electrical functioning. The document states that "non-clinical, bench testing included performance verification to confirm acceptable performance of device features and functions" and "It was functionally tested and found to be in compliance with the specification." This implies standalone testing of the device's electrical and software functions.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" was established by engineering specifications, international standards (IEC, EN), and regulatory guidance. For example:

• Electrical safety tests against IEC 60601 series standards.
• EMC tests against IEC 60601-1-2 and EN 301 489-1 & 17.
• Software validation against EN 62304, EN ISO 13485, EN ISO 14971, EN 62366 and FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices.
• Performance parameters (voltage, current, frequency, etc.) were compared against the predicate device's specifications and relevant safety limits (e.g., current density limit of 2mA/cm2 from IEC60601-2-10).

8. The sample size for the training set

Not applicable. The Healy device is a hardware medical device (TENS) with associated software for control. The provided documentation does not describe an AI/ML component that uses a "training set" in the typical sense for learning or pattern recognition.

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

Not applicable, as no training set for an AI/ML component is mentioned or relevant to this submission.

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