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• Specific indications: it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
• Clinical settings: should be used under the instruction or prescription by qualified health professionals prior to the applications of the device at home or hospital facilities.

Besmed various models of TENS, BE-550 / BE-660

The provided text is an FDA 510(k) clearance letter for Besmed various models of TENS, BE-550 / BE-660. The letter states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.

However, this document does not contain any information regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or details about any studies (standalone, MRMC, or otherwise) that would "prove the device meets the acceptance criteria."

The clearance is based on substantial equivalence to a predicate device, as explicitly stated: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

Therefore, I cannot provide the requested table or answer most of the questions because the information is not present in the provided text.

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