Search Results

• 1. RELAXATION OF MUSCLE SPASM.
• 2. PREVENTION OR RETARDATION OF DISUSE ATROPHY.
• 3. INCREASING LOCAL BLOOD CIRCULATION.
• 4. MUSCLE-RE-EDUCATION.
• 5. IMMEDIATE POST SURGICAL STIMULATION OF CALF MUSCLES TO PREVENT VENOUS THROMBOSIS.
• 6. MAINTAINING OR INCREASING RANGE OF MOTION.

SD-970EMS ELECTRICAL MUSCULAR STIMULATOR

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the "SD-970EMS Electrical Muscular Stimulator," indicating that the device has been determined to be substantially equivalent to a predicate device.

The letter mentions:

• Trade Name: SD-970EMS Electrical Muscular Stimulator
• Regulatory Class: II
• Product Code: IPF
• Indications For Use: Relaxation of muscle spasm, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, and maintaining or increasing range of motion.

It does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study (sample size, data provenance, expert numbers, adjudication methods, MRMC studies, standalone performance, ground truth types).
• Information on training sets or how their ground truth was established.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

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