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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.

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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.

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The ReGrasp is an electrical stimulation device indicated for the following uses:

Functional Electrical Stimulation (FES):

• Improvement of hand-function and active range of motion in patients with hemiplegia or upper limb paralysis due to stroke, traumatic or acquired brain injury, or C5 level cervical spinal cord injury.

Neuromuscular Electrical Stimulation (NMES):

• Maintenance and/or increase of range of motion
• Prevention and/or reduction of disuse atrophy
• Increase of local blood circulation
• Reduction of muscle spasms
• Muscle re-education

Not Found

This is a 510(k) clearance letter for the ReGrasp device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. A 510(k) clearance is based on demonstrating substantial equivalence to a predicate device, not on specific performance criteria derived from a clinical study as would be seen for a PMA.

Therefore, I cannot provide the requested information from the given document.

Ask a specific question about this device