(282 days)
This device is restricted to sale or use by or on the order of a physician licensed in the state in which he or she is practicing. It is to be used solely for the symptomatic relief of chronic intractable pain.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called "MICRO-II MICROCURRENT TENS." This type of document is a regulatory approval, not a scientific study report. It states that the device is "substantially equivalent" to legally marketed predicate devices.
Therefore, this document does not contain the information requested regarding:
- Acceptance criteria and reported device performance.
- Details of a study proving the device meets acceptance criteria.
- Sample sizes, data provenance, number/qualifications of experts, adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used or how it was established for training or testing.
- Training set sample size.
The document's purpose is to grant market clearance based on substantial equivalence, implying that the device performs similarly to existing, approved devices, rather than presenting novel performance data from a new study against explicit 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).