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The FT610-B is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and lower extremities due to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication, it also provides a heat function intended to temporarily relieve minor aches and pains.

The subject device is a self-adhesive TENS device with 15 adjustable intensity levels for pain relief. Moreover, it also provides a heat function which can be used alone, or in conjunction with the TENS function simultaneously. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS selftreatment regime.

TENS device works by passing electrical currents over the skin via a set of gel pads. As a transfer medium, the gel pads are subject to natural wear and tear, and must be replaced when they stop providing sufficient contact or the main unit no longer sticks to the skin completely. Failure to replace the gel pad may lead to skin irritation as a result of heightened current density in particular areas.

This device is only compatible with the 50 mm x 56 mm gel pads which are the OTC medical device cleared by FDA under K132588, and come with the device.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device. It does not contain information about acceptance criteria and studies in the context of AI/ML device performance or clinical trials with human readers. Instead, it describes a substantial equivalence determination for a physical medical device (HIVOX OTC Electrical Stimulator, FT610-B) based on non-clinical testing and comparison to predicate devices.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes, data provenance, or number/qualifications of experts for a test set.
• Adjudication methods for a test set.
• MRMC comparative effectiveness studies or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set or how its ground truth was established.

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."

Instead, I can provide information based on the non-clinical testing for the physical device:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical Testing):

The document states that "All the test results demonstrate the subject device, HIVOX OTC Electrical Stimulator (FT610-B), meets the requirements of its pre-defined acceptance criteria and intended use". Specific numerical acceptance criteria are not detailed in the provided text, but the device performance was measured against recognized consensus standards and guidance documents.

Regarding the other points, the document explicitly states or implies they are not applicable:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of non-clinical device testing for substantial equivalence.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of expert consensus for AI/ML performance is not relevant here. Non-clinical tests typically involve engineers and technicians evaluating against technical standards.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical testing.
• 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. The device is a physical Transcutaneous Electrical Nerve Stimulator, not an AI/ML diagnostic or assistive tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, "ground truth" is typically defined by the specifications in the standards themselves (e.g., specific electrical output values, temperature limits, material properties).
• 8. The sample size for the training set: Not applicable. This device does not use a "training set" in the context of machine learning.
• 9. How the ground truth for the training set was established: Not applicable.

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