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

Electrical Muscle Stimulation (EMS):
The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

Not Found

I am sorry, but the provided FDA 510(k) Clearance Letter for the "OTC 4-Channel Rechargeable TENS Unit" (K251429) does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a clearance letter, which means the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It focuses on the regulatory aspects of the clearance, such as:

• Device name and regulation
• Regulatory class and product code
• Substantial equivalence determination
• General controls and additional controls applicable to the device
• References to FDA guidance documents and regulations (e.g., Quality System regulation, UDI Rule)
• Contact information for the FDA

Specifically, the document does NOT include:

1. A table of acceptance criteria and reported device performance: This type of data would typically be found in the actual 510(k) submission, not the clearance letter.
2. Sample size used for the test set and data provenance: Again, this is detailed information from the testing portion of the submission.
3. Number of experts and their qualifications for establishing ground truth: Not mentioned in this regulatory letter.
4. Adjudication method: Not applicable or mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results: This applies to AI/CAD devices, and the TENS unit is a physical device, so such a study would not be relevant.
6. Standalone (algorithm only) performance: Not applicable for a TENS unit.
7. Type of ground truth used: Not applicable or mentioned.
8. Sample size for the training set: Not applicable for a TENS unit (unless it incorporates some form of adaptive AI, which is not indicated here).
9. How the ground truth for the training set was established: Not applicable for a TENS unit.

The provided text only states the Indications for Use for the TENS and EMS functions. To find the specific performance data and acceptance criteria, you would need to access the full 510(k) submission (if it were publicly available in that format, which it generally is not for the detailed technical reports). The clearance letter confirms that the FDA reviewed such data and found it adequate for substantial equivalence, but it does not reproduce that data.

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