(13 days)
The S21 Transcutaneous Electrical Nerve Stimulator (TENS) device is intended to by used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain by sending electrical impulses through the skin to the nerves lying directly beneath the skin surface. These impulses help to block the body's ability to send a pain message to the brain, thereby reducing the pain sensation. The S21 is a dual channel device that produces constant micro ampere currents with the selected envelopes, waveforms, frequencies, and polarity, with a maximum voltage of 30 volts.
The S21 is a dual channel device that produces constant micro ampere currents with the selected envelopes, waveforms, frequencies, and polarity, with a maximum voltage of 30 volts.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, comparative effectiveness studies, standalone performance, or ground truth establishment.
The document is a 510(k) premarket notification letter from the FDA regarding a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms that the device is substantially equivalent to a legally marketed predicate device and can proceed to market. The "Indications For Use" section describes the intended use of the device but does not include any performance metrics or study results.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or the detailed study information.
§ 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).