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Avéli is indicated for temporary reduction in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating benefits through three months of observation.

Avéli is a sterile, single-use manual instrument that cuts fibrous tissue (septa) beneath moderate to severe cellulite for temporary reduction in the appearance of cellulite in the buttocks and thigh areas of adult females. The device consists of a handle and a distal end. The handle houses components used to actuate the moving parts at the distal end of the device. The distal end of the device is advanced into subcutaneous tissue through a small incision to a procedure location. An integrated light source provides illumination and allows the user to track and advance to the procedure location. The distal end of the device contains a blunt link and a sharpened link forming a distal hook. When the handle is moved in a retrograde fashion, the distal hook next to a fibrous septum captures the septum resulting in tugging. The user feels the resistance, confirming that a septum under a cellulite depression has been identified. The user then engages a sharpened link to be exposed at the distal end of the device. The user applies additional retrograde motion to sever the fibrous septum, and then retracts the sharpened link and the blunt link into the device, allowing removal without further tissue capture. The step is repeated for each visible cellulite depression.

The manufacturer, NC8, Inc. (now Revelle Aesthetics, Inc.), performed a clinical study to evaluate the safety and effectiveness of the Avéli device for the treatment of cellulite. The study involved a prospective, non-randomized, multi-center design across nine investigational sites.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: The text states "All participants served as their own control." While the exact number of participants is not explicitly given as a single number for the "test set" in the context of an algorithm, it refers to the participants in the pivotal clinical study. The study included "females between the ages of 26 and 54 with moderate to severe cellulite and BMI between 19 and 30." The images of these participants collected before and 3-months after the procedure would constitute the data used for evaluation.
• Data Provenance: The study was a "prospective, non-randomized, multi-center study conducted to evaluate the safety and effectiveness of Avéli." The text does not specify the country of origin, but given the FDA submission, it is highly likely it was conducted in the United States or followed international standards acceptable to the FDA. The data is prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Three (3)
• Qualifications of Experts: "Independent, blinded physician evaluators." (Further specific qualifications like years of experience or specialty, e.g., dermatology, plastic surgery, are not provided).

4. Adjudication method for the test set

• The text describes the effectiveness evaluation as being "determined by three independent, blinded physician evaluators." This implies a form of consensus or independent grading from multiple readers. However, a specific adjudication method (e.g., 2+1, 3+1, majority vote if there were discrepancies, or average score) is not explicitly stated. It just says it was "determined by" the three evaluators.

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, an MRMC comparative effectiveness study involving AI assistance for human readers was not done. This study evaluated the effectiveness of the device (Avéli) in treating cellulite, not an AI algorithm assisting human readers. The evaluators assessed patient photographs to determine the device's efficacy.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No, a standalone algorithm performance study was not done. The primary effectiveness endpoint was based on human evaluators assessing photographs, which is a human-in-the-loop assessment of the device's effectiveness, not an algorithm's.

7. The type of ground truth used

• The ground truth for effectiveness was based on expert consensus/opinion from physician evaluators assessing before and after photographs, specifically the "mean change (improvement) in the Cellulite Severity Score (CSS)." The "Cellulite Severity Score" itself is a clinical assessment tool.

8. The sample size for the training set

• The document does not mention a training set or any machine learning/AI component for which a training set would be required. The clinical study described is for the Avéli device itself, which is a manual surgical instrument, not an AI-powered diagnostic or treatment planning system. Therefore, the concept of a "training set" for an algorithm is not applicable here.

9. How the ground truth for the training set was established

• As there is no mention of an algorithm or training set, this information is not applicable to the provided text.

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