(198 days)
The VelaSmooth, Shaper is indicated for temporary reduction of thighs circumferences.
The VelaSmooth, Shaper 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 510(k) summary for the VelaSmooth, Shaper device is very concise and primarily focuses on establishing substantial equivalence to a predicate device for the indication of temporary reduction of thigh circumferences. It does not contain the detailed information typically found in a clinical study report that would allow for a comprehensive description of acceptance criteria and the study proving it.
Specifically, the document does not provide the following information from your request:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document states: "Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences exit." This implies that a performance characteristic was assessed, but the details of what that characteristic was, how it was measured, and what the specific acceptance criteria were are not provided. The phrase "no significant differences" typically refers to substantial equivalence to a predicate device rather than meeting specific quantifiable performance metrics against pre-defined acceptance criteria in a standalone study.
Without access to the full 510(k) submission, which would likely contain a more detailed clinical summary or study report, it's impossible to answer most of your questions based only on the provided text. The summary provided is a high-level overview for regulatory filing, not a detailed scientific publication of a clinical study.
§ 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.