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TENS (For model EM-6000, EM-6100 & EM-6300) : intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS B/N/M/S1/S2 adjustable mode & TENS Modes P to P6 for EM-6300).

EMS (For model EM-6000, EM-6200 & EM-6300): intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS C/S/A adjustable mode & EMS Modes P7 to P12 for EM-6300).

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I am sorry, but the provided text does not contain any information about acceptance criteria for a medical device or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a TENS/EMS device, confirming its substantial equivalence to a predicate device. It discusses regulatory compliance and indications for use but does not detail performance acceptance criteria or specific study results to demonstrate those criteria are met.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.

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