(42 days)
Relaxation of muscle spasms; 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 text is an FDA 510(k) clearance letter for a device named "Prelivia" (Product Code: IPF, Regulation Number: 21 CFR 890.5850, Regulation Name: Powered muscle stimulator).
This document does not contain any information about:
- Acceptance criteria and reported device performance through testing.
- Sample sizes for test or training sets.
- Data provenance.
- Number of experts and their qualifications used for ground truth.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements for marketing the device. The "Indications for Use" section lists the intended therapeutic applications of the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The requested information regarding the performance study and its methodology is not present in this FDA clearance letter.
§ 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).