(113 days)
The Vela smooth, Shaper is indicated for the relief of minor muscle aches and pain. Relief of muscle spam Temporary improvement of local blood circulation. Temporary reduction in the appearance of cellulite.
The Vela smooth, Shaper treatment is based on the simultaneous application of heat to the tissue with light energy at a controlled Infrared wavelength, conducted RF energy, and mechanical manipulations of the skin.
This 510(k) summary does not contain the detailed information required to fill out the table and answer all the questions. The provided document is a summary of safety and effectiveness, and the FDA letter approving the device based on substantial equivalence to predicate devices. It does not include information about specific acceptance criteria or a detailed study proving the device meets those criteria in the way a clinical trial report would.
Here's what can be inferred from the document and why other information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Relief of minor muscle aches and pain: | Not explicitly stated in terms of specific metrics or percentages. The device is "indicated for the relief of minor muscle aches and pain." |
| Relief of muscle spasm: | Not explicitly stated in terms of specific metrics or percentages. The device is "indicated for the relief of muscle spasm." |
| Temporary improvement of local blood circulation: | Not explicitly stated in terms of specific metrics or percentages. The device is "indicated for temporary improvement of local blood circulation." |
| Temporary reduction in the appearance of cellulite: | Not explicitly stated in terms of specific metrics or percentages. The device is "indicated for temporary reduction in the appearance of cellulite." |
Explanation for missing data: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical trial results with specific performance metrics against pre-defined acceptance criteria. The "Indications for Use" section lists the intended benefits, but doesn't quantify "relief," "improvement," or "reduction" with specific percentages or scales.
2. Sample size used for the test set and the data provenance:
- Sample size: Not available in this document.
- Data provenance: Not available in this document. (Retrospective/prospective, country of origin)
Explanation: A 510(k) summary doesn't typically include details about the sample size or provenance of data from specific clinical trials unless it's a new clinical indication requiring such data. The submission relies on the established safety and effectiveness of the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not available in this document.
- Qualifications of experts: Not available in this document.
Explanation: This information would be present in a detailed study report, particularly for subjective outcomes like cellulite appearance. It's not part of a 510(k) summary focused on substantial equivalence.
4. Adjudication method for the test set:
- Not available in this document.
Explanation: Adjudication methods (like 2+1 or 3+1) are specified in clinical trial protocols when multiple readers or experts assess outcomes. This is not included in a 510(k) summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, nor would it be relevant for this type of device and submission.
- Effect size: Not applicable.
Explanation: This device is a physical therapeutic device (Vela smooth, Shaper) that uses heat, light, RF energy, and mechanical manipulation. It is not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
Explanation: As mentioned above, this is a physical therapeutic device, not an algorithm or AI system.
7. The type of ground truth used:
- Not explicitly stated. However, for the indications listed (muscle aches, spasm, blood circulation, cellulite appearance), the "ground truth" would likely involve subjective patient self-reports for pain/spasm, objective measures for blood circulation (e.g., Doppler), and subjective assessments (e.g., visual grading, photographic comparison) perhaps by a clinician or panel for cellulite appearance.
Explanation: Since this is a 510(k) based on substantial equivalence, the "ground truth" for the predicate devices' effectiveness would have been established through clinical observations and measurements over time, rather than a single, easily defined ground truth like pathology for a diagnostic device.
8. The sample size for the training set:
- Not applicable.
Explanation: This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable.
Explanation: This device is not an AI/machine learning model, so there is no "training set" or ground truth establishment for a training set.
§ 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.