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The Cabochon System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 1 year of observation.

The Cabochon System is the same (identical) device as the legally marketed predicate and intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The release of subcutaneous tissue for improvement in the appearance of cellulite is a minimally invasive surgical technique by physicians using a variety of manual surgical instruments and accessories. The Cabochon device consists of a powered cutting blade and a means for instrument guidance to control the depth, size and shape of the area of the tissue release.

The Cabochon System is intended for long-term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 55 subjects.
• Data Provenance: Prospective, multi-center, non-randomized open-label safety and effectiveness study conducted in 3 US centers.

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

• The document implies that the ground truth for the primary and powered secondary endpoints (Cellulite Severity Scale and grade improvement) was established by independent physician assessment of subject photographs.
• The document also refers to independent physician assessment for the overall study success criteria, GAIS, and correct selection of photographs.
• The qualifications of these experts are not explicitly stated beyond being "independent physicians."

4. Adjudication method for the test set:

• The document mentions "independent and blinded review of the photographs." While it specifies "independent physician assessment," it does not explicitly state a formal adjudication method like 2+1 or 3+1 for discrepancies in evaluation. It is implied that the assessment contributed to the reported metrics.

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 was not done. The study evaluated the Cabochon System (a medical device for cellulite treatment) and its effectiveness, not an AI system.

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

• No, a standalone algorithm-only performance study was not done. The Cabochon System is a powered surgical instrument, not an AI algorithm. Its performance was evaluated through clinical trials involving human subjects, physicians, and their assessments.

7. The type of ground truth used:

• The ground truth was based on expert consensus/assessment (independent physician assessment) of subject photographs against established clinical scales (Cellulite Severity Scale, severity grades, Global Aesthetic Improvement Scale). It was observational and subjective assessment by experts.

8. The sample size for the training set:

• Not applicable. The Cabochon System is a physical medical device, not an AI algorithm that requires a training set in the conventional sense. The "training" for the device would involve physician training on its use, but this is not reflected as a data "training set" for an algorithm.

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

• Not applicable, as there is no mention of an algorithm or training set in the context of this device's regulatory submission.

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The Cabochon System is intended for the short-term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females.

The Cabochon System temporarily improves the appearance of cellulite by controlled release (cutting) of the subcutaneous tissue underneath the cellulite depressions or dimples. The release of subcutaneous tissue for improvement in the appearance of cellulite is a surgical technique currently performed by physicians using a variety of manual surgical instruments. The depth and specific area of release achieved with the manual surgical instruments are generally variable and user-dependent. The Cabochon System has been designed to provide added control over both the depth and area of release.

This document describes the De Novo Classification Request for the Cabochon System, a powered surgical instrument intended to improve the appearance of cellulite. Below is a summary of the acceptance criteria and the study that demonstrates the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 55 subjects.
• Data Provenance: Prospective, multi-center study conducted in 3 US centers.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Number of Experts: Three independent physician evaluators.
• Qualifications: The document states they were "independent physician evaluators," but does not explicitly detail their specific qualifications (e.g., years of experience or specialty like a radiologist). They were "individually trained, and monitored throughout the evaluation."

4. Adjudication Method for the Test Set

• The document describes a blinded evaluation process where "blinded before (baseline) and after photographs were provided side by side in randomized orientation (L-R)" to the three independent physician evaluators.
• The evaluators were asked to "identify the baseline and after photographs, rate the overall improvement... according to a Global Aesthetic Improvement Scale (GAIS)."
• The overall study success criteria involved statistically significant changes as determined by this independent physician assessment. While not explicitly stated as a consensus or majority vote (like 2+1 or 3+1), the independent assessment by three evaluators and the statistical analysis of their ratings served as the adjudication method for effectiveness endpoints. "All reliability and repeatability measures were met and validated the methodology."

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 in the context of comparing human readers with AI assistance. This device is a surgical instrument, not an AI diagnostic tool. The "readers" were human physician evaluators assessing photographs of patients treated by the device, not interpreting images or data generated by an AI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

• No, a standalone algorithm-only performance study was not done. The device is a physical surgical instrument; it incorporates no software or AI for standalone performance evaluation.

7. The Type of Ground Truth Used

• The ground truth for effectiveness was established through a combination of:
  • Expert Consensus/Independent Physician Assessment: Three independent physician evaluators assessed "blinded before (baseline) and after photographs" to determine perceived improvement in cellulite appearance and severity. They used a Global Aesthetic Improvement Scale (GAIS) and a 0-5 point Cellulite Severity Scale.
  • Subject Reported Outcomes: Subject satisfaction and subject-reported pain levels were also collected.
• For safety, the ground truth was based on reported adverse events (or lack thereof) monitored by a Data Safety Monitoring Board (DSMB).

8. The Sample Size for the Training Set

• The document mentions "Feasibility clinical testing... in 1 outside the US (OUS) and 1 US center where 56 subjects received treatment with the device with follow-up out to 1-year in the US site."
• "Data from the feasibility study was also used to develop an appropriate pivotal study."
• This suggests the 56 subjects from the feasibility study might have served as a "training set" in a broad sense, used to refine the device and study protocol before the pivotal study. However, this is not a "training set" in the context of machine learning, as the device does not employ AI.

9. How the Ground Truth for the Training Set Was Established

• Given that the "training set" refers to the feasibility study, the ground truth was likely established through similar means as the pivotal study:
  • Observation of safety events (adverse events).
  • Assessment of effectiveness endpoints (though possibly with different scales or methods, as it was used to "develop an appropriate pivotal study," implying refinement).
  • It is explicitly stated that "the effectiveness endpoints were achieved" in the feasibility study.

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