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The Impulse HVG Stimulator can be used to treat and provide therapeutic relief for the following indications:

• relaxation of muscle spasm
• prevention or retardation of disuse atrophy
• increasing local blood circulation, and
• maintaining or increasing range of motion

The Impulse HVG has the same intended medical uses as the listed predicate device (PGS 3000).

Impulse HVG

I am sorry, but the provided text from the FDA 510(k) letter for the Impulse HVG does not contain the detailed information required to answer your request. The letter confirms substantial equivalence but does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Information on multi-reader multi-case (MRMC) studies or effect sizes.
6. Results of standalone algorithm performance.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The letter focuses on regulatory approval based on substantial equivalence to a predicate device (PGS 3000) for specific indications for use, but it does not detail the specific studies, performance metrics, or statistical analyses that would typically be found in a more comprehensive clinical or technical study report.

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