(194 days)
Transcutaneous Electrical Nerve Stimulation devices are used for the symptomatic relief and management of chronic intractable pain and for the symptomatic relief of acute post traumatic pain problems.
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This document is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device called "American Imex Premier Plus." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices for the indications for use stated in the enclosure (which is "symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems").
Since the document is a regulatory clearance letter and not a study report, it inherently cannot answer your specific questions related to acceptance criteria and study details.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).