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Specific indications: used to apply an electrical current to electrodes on patient's skin at some limited ● positions to function as:

• Relaxation of muscle spasms;
• Prevention or retardation of disuse atrophy
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion.
  Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for . the treatment of medical diseases and conditions.

Home Care various models of Powered Muscle Stimulator, HT-329M1, HT-329M2, HT-329M3, and HT-329M4

The provided text is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria or a study proving device performance. This document is a regulatory approval notice, indicating that the Home Care Powered Muscle Stimulator (various models) is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC results from this document.

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