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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.

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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:

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.

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