(290 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.
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I am sorry, but this document does not contain the information required to answer your request. This document is a 510(k) clearance letter for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.
The information you are requesting, such as acceptance criteria, study details, sample sizes, expert qualifications, and ground truth methodologies, are typically found in the Premarket Notification (510(k)) submission itself, which is a much more detailed technical document submitted to the FDA. This letter is the FDA's response to that submission.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, qualifications of experts, adjudication methods for a test set.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used.
- The sample size for the training set or how its ground truth was established.
§ 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).