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The VelaShape is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.

The VelaShape treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted RF energy, and the mechanical manipulation is derived from massage and/or vacuum.

The provided text is a 510(k) summary for the VelaShape device, which is a reclassification and an updated version of a previously cleared device. The primary purpose of this 510(k) is to address an increase in RF power for the VelaShape, asserting it does not change the intended use or fundamental technology.

The document does not contain any information about acceptance criteria or a study proving that the device meets those criteria, as typically required for AI/ML device submissions. This 510(k) is for a physical medical device (VelaShape for body contouring/pain relief) and not an AI/ML diagnostic or therapeutic software device. Therefore, the requested information about acceptance criteria, sample sizes, ground truth, expert adjudication, or MRMC studies for an AI/ML device is not applicable and not present in the provided text.

The closest relevant information is a general statement from the manufacturer that "The modification of the increased RF power raises no new issues of safety or effectiveness." This is a regulatory assertion rather than a description of a performance study with acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text, as it pertains to a different type of medical device submission.

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