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510(k) Data Aggregation
(90 days)
THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS : - Relaxation of muscle spasms 1. - 2. Prevention or retardation of disuse atrophy - Increasing local blood circulation 3 . - Muscle re-education 4 . - Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis - Maintaining or increasing range of motion 6.
MEDS-3 NEUROMUSCULAR STIMULATOR
The provided text is a 510(k) clearance letter from the FDA for the MEDS-3 Neuromuscular Stimulator. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document states that the device is "substantially equivalent" to legally marketed predicate devices. This implies that the device was compared against existing, similar devices already cleared for market, rather than undergoing a de novo study with explicit acceptance criteria.
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(90 days)
SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN
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I am sorry, but the provided text does not contain any information about acceptance criteria for a device, a study that proves the device meets those criteria, or any of the detailed aspects like sample sizes, expert qualifications, adjudication methods, or specific study types.
The document is a clearance letter from the FDA regarding a 510(k) premarket notification for the "MEDS-3 Neuromuscular Stimulator." It primarily states that the device has been determined to be substantially equivalent to a legally marketed predicate device for the symptomatic relief of chronic intractable pain. It outlines the regulatory classification and general controls applicable to the device but does not include performance data, study designs, or acceptance criteria.
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