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This TENS device is to be used for temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

The Counter Pain Therapy Device, Model P.T.S.-IV (K161537) is identical to the previous cleared version of the device with the same name (K132993). The purpose of this 510(k) submission is to seek different (expanded) Indications for Use. The only changes are in the 'Indication for Use Statement'.

The Counter Pain Therapy Device, Model P.T.S.-IV features two channels and seven (7) preset programs. The output of both channels can be adjusted individually for intensity in sixteen (16) steps and the treatment time is selectable from 20, 30 or 40 minutes. All features are well indicated by large icons on a backlit LCD screen for easy reading.

The device is powered by three (3) rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied for the device.

The Pain Therapy Device consists of the handheld main unit (controller), two pairs of self-adhesive electrodes, a plug-in charging unit (adaptor 120VAC to 5VDC) and two pairs of electrode cables.

This document describes the regulatory clearance (K161537) for the OTC TENS Device, Model PTS-IV. However, it explicitly states that no clinical tests were performed or relied upon to determine substantial equivalence for this specific submission because the device itself is identical to a previously cleared version (K132993), and the only change made was an expansion of the Indications for Use. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of clinical performance, cannot be fully provided from this document.

The document primarily focuses on non-clinical testing and substantial equivalence to predicate devices based on design, technological characteristics, and safety standards.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested details are not available:

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

• Acceptance Criteria: The document refers to meeting the requirements of recognized consensus standards for safety and performance. These standards are the acceptance criteria for non-clinical aspects.
• Reported Device Performance: The performance is stated in terms of compliance with these standards.

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 / Not provided for clinical performance. The document explicitly states: "Counter did not conduct, nor rely upon, clinical tests to determine substantial equivalence of the Pain Therapy Device Model P.T.S.-IV. vs. the predicates."
• For non-clinical testing, the "sample size" would refer to the number of devices tested to the standards. This specific number is not provided, only that "testing" was performed. The data provenance would be from internal company testing and third-party lab testing for standards compliance (e.g., electrical safety).

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. No clinical test set with human data and expert-established ground truth was used for this specific 510(k) submission. The regulatory decision was based on substantial equivalence to predicate devices and non-clinical engineering and safety testing.

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

• Not applicable. No clinical test set requiring adjudication 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 device is a Transcutaneous Electrical Nerve Stimulator (TENS device), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• Not applicable. The device is a TENS unit, not an algorithm. Its performance is inherent in its electrical output and mechanical operation, as demonstrated by compliance with engineering standards.

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

• For the non-clinical tests, the "ground truth" was established by the requirements of the international consensus standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) which define the acceptable limits and performance criteria for safety and electrical characteristics.
• For biocompatibility, the ground truth would be chemical/biological analyses demonstrating safety as per relevant biocompatibility standards for medical devices, which were part of the electrode's separate FDA clearance.
• For software, the ground truth was the expected functional specifications and safety requirements as defined internally and verified through testing.

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI that requires a "training set."

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

• Not applicable. As above, there is no training set for this type of device.

In summary:

This 510(k) cleared the OTC TENS Device, Model PTS-IV, by demonstrating substantial equivalence to a previously cleared version of the same device (K132993) and to another predicate device (K121757) for its expanded indications for use. The clearance was based entirely on non-clinical testing which confirmed the device's compliance with established safety and performance standards (IEC 60601 series). No clinical studies or human performance data were used for this submission, as the physical device itself had already been vetted in a prior submission, and the current submission only sought to expand its marketing claims (Indications for Use) based on existing equivalence.

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