(57 days)
Transcutaneous Electrical Nerve Stimulation (TENS) devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.
Not Found
This document is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria, a specific study proving the device meets acceptance criteria, sample sizes for test sets or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance studies, or how ground truth was established.
Therefore, I cannot provide the requested table and details as the input document does not contain this type of information. It primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.
§ 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).