(262 days)
TENS mode: It is used for temporary relief of pain associated with sore and aching muscles in the neck, joint, hip, hand, abdomen, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. EMS mode: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
Not Found
The provided text is an FDA 510(k) clearance letter for a TENS and EMS Stimulation device. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the document DOES NOT contain information about specific acceptance criteria and a study that proves the device meets those criteria, especially not in the context of an AI/ML medical device.
The document is a regulatory clearance for a physical device (TENS and EMS stimulator) and contains:
- The FDA's determination of substantial equivalence.
- Regulatory information and requirements for the manufacturer.
- The indications for use for the TENS and EMS modes.
Therefore, I cannot extract the requested information (table of acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details) from this document. This information would typically be found in a separate clinical study report or a more detailed submission document (which is not included in the provided text).
§ 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).