(190 days)
Management and symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device named "TruWave," which is a transcutaneous electrical nerve stimulator (TENS) for pain relief. This type of document, while indicating regulatory approval, does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.
FDA 510(k) clearances are based on a determination of "substantial equivalence" to a legally marketed predicate device, not necessarily on new clinical studies demonstrating device performance against specific, pre-defined acceptance criteria in the same way a PMA (Pre-Market Approval) or novel device would require.
Therefore, I cannot extract the requested information (acceptance criteria, device performance table, sample sizes, ground truth details, MRMC study results, etc.) from the provided text. This information would typically be found in the 510(k) submission itself, accessible only through a Freedom of Information Act (FOIA) request or directly from the manufacturer, not in the public clearance letter.
§ 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).