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The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

The WL-2206 is the device which generates the small real-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.

This 510(k) summary does not contain the information required to populate the requested table and sections regarding acceptance criteria and a study proving the device meets those criteria. The provided document is a 510(k) Summary for a medical device (IF series True sine interferential stimulator) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study with specific acceptance criteria.

Specifically:

• No acceptance criteria or reported device performance are mentioned. The document states compliance with voluntary standards (ANSI/AAMI, EN 60601 series) and software verification, but these relate to safety and general electrical performance, not clinical efficacy or specific performance metrics that would typically have acceptance criteria.
• No study details are provided. The submission emphasizes that "verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device." However, no details about these specific tests, their methodology, sample sizes, ground truth establishment, or results are given.
• The document explicitly states that the device has the "same intended use and technological characteristics" as the predicate devices, implying that no new clinical performance claims or studies are needed to establish effectiveness beyond demonstrating substantial equivalence to existing cleared devices.

Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. This information is not present in the provided 510(k) summary.

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