(27 days)
The indications for use of this device are:
- 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.
- Maintaining or increasing range of motion.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "Vectorsurge 4 Interferential Therapy Unit." This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed.
However, this document does not contain the detailed information required to answer your specific questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trial data or detailed performance studies in the same way a Premarket Approval (PMA) application would. While some performance data is typically submitted as part of a 510(k), the FDA letter itself does not detail this information.
To answer your questions, one would need access to the full 510(k) submission document (K993821), which is not provided here.
Therefore, I cannot provide the requested information from the text you've given.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).