(47 days)
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.