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SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN

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I am sorry, but based on the provided text, I cannot provide details on the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a Neuromuscular Stimulator. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information. However, it does not contain any information about specific acceptance criteria, study methodologies, sample sizes, expert qualifications, ground truth establishment, or performance metrics for the MEDS-4 Neuromuscular Stimulator itself. The document is primarily an administrative approval notice, not a detailed technical report of a clinical study.

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THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS :

• 1 . Relaxation of muscle spasms
• 2. Prevention or retardation of disuse atrophy
• 3. Increasing local blood circulation
• 4 . Muscle re-education
• Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis
• Maintaining or increasing range of motion 6.

MEDS-4 NEUROMUSCULAR STIMULATOR

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "MEDS-4 Neuromuscular Stimulator." It confirms that the device is substantially equivalent to legally marketed predicate devices and lists the indications for use.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information based on the input text. The 510(k) clearance letter focuses on regulatory approval based on substantial equivalence to existing devices, not on a detailed presentation of performance study results against specific acceptance criteria.

Ask a specific question about this device