(82 days)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
Not Found
I apologize, but the provided text from the FDA 510(k) letter for the "Electronic Pulse Stimulator" does not contain information about acceptance criteria for device performance, nor details of a study proving the device meets such criteria.
The document is a standard FDA clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use. It outlines regulatory requirements and contact information, but it does not delve into the specifics of performance testing or clinical studies with the kind of detail you are requesting (e.g., sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance).
Therefore, I cannot provide the requested table or answer the specific questions about the study and acceptance criteria based on 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).