(620 days)
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
| Acceptance Criteria (Endpoint) | Reported Device Performance |
|---|---|
| Primary Safety Endpoint: No Unanticipated Adverse Device Effects (UADE) and no Serious Adverse Events (SAE) related to the device or procedure. | Achieved: No UADE and no SAE occurred in the study. |
| Primary Effectiveness Endpoint: Achievement of point average reduction in the (b)(4) as determined by independent physician assessment of subject photographs (Baseline-3 months). | Achieved: Average improvement was (b)(4) with a one-sided lower (b)(4) confidence limit of a point improvement (Baseline-3 months). |
| Powered Secondary Effectiveness Endpoint: Improvement of one grade or more in cellulite severity (none, mild, moderate, severe) in (b)(4) of treated subjects as determined by independent physician assessment of subject photographs (Baseline-3 months). | Achieved: (b)(4) of treated subjects had improvement of 1 grade with a lower two-sided (b)(4) confidence limit of (b)(4). |
| Secondary Effectiveness Measure (Photographic Selection): (b)(4) or higher average rate of correct selection by independent physician assessment of blinded subject photographs. | Achieved: Average rate of correct selection was (b)(4) with a lower two-sided (b)(4) confidence limit of (b)(4). |
| Secondary Effectiveness Measure (GAIS): Improvement in subject appearance according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent physician assessment of subject photographs. | Achieved: (b)(4) of subjects had noticeable improvement by the GAIS, and (b)(4) were characterized as having marked improvement or better. |
| Secondary Measure (Subject Satisfaction): Subject satisfaction with the appearance of their cellulite as rated on a (b)(4) scale at 3-month follow-up. | Achieved: Over (b)(4) of the subjects were either satisfied or very satisfied. |
| Additional Study Measure (Subject Reported Pain): Acceptable pain levels using a (b)(4) numerical rating scale (NRS). | Acceptable: On average, (b)(4) of subjects rated pain (b)(4) at 3 days, and over (b)(4) rated pain (b)(4) thereafter. The majority of pain was "aching" and occurred only with touch or pressure. |
| Biocompatibility: Device materials in patient contact meet ISO 10993-1 requirements. | Conforms to ISO 10993-1, with various materials certified ISO-10933-1 or USP Class VI compliant, and recognized biomaterials for blade and needle. |
| Shelf Life/Sterility: Sterilization process validated to AAMI/ISO 11135:2007 (SAL ≤ 10-5), and a 6-month shelf life established. | Complies with AAMI/ISO 11135:2007; 6-month shelf life verified through accelerated and real-time aging, and performance testing. |
| Electrical Safety: Device meets IEC 60601-1:2003. | Compliant. |
| Electromagnetic Compatibility: Device meets IEC 60601-1-2:2007. | Compliant (Class B). |
| Non-Clinical Performance: Bench and ex vivo testing show design specifications, durability, and mechanical integrity are met. | Successfully completed with multiple lots of aged and time-zero product; devices met pre-determined acceptance criteria. Ex vivo studies verified depth and area of tissue release. |
| Animal Performance: In vivo animal studies verify safety of release methodology and healing response. | Demonstrated minor bleeding, release plane within specification, and no necrotic areas. |
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.
§ 878.4790 Powered surgical instrument for improvement in the appearance of cellulite.
(a)
Identification. A powered surgical instrument for improvement in the appearance of cellulite is a prescription device that is used for the controlled release of subcutaneous tissue for improvement in the appearance of cellulite. The device consists of a cutting tool powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical testing must be performed to demonstrate that the device meets all design specifications and performance requirements, and to demonstrate durability and mechanical integrity of the device.
(2) In vivo evaluation of the device must demonstrate device performance, including the safety of the release methodology and blood loss at the treatment sites.
(3) All elements of the device that may contact the patient must be demonstrated to be biocompatible.
(4) Electrical safety and electromagnetic compatibility of the device must be demonstrated.
(5) The labeling must include a summary of in vivo evaluation data and all the device specific warnings, precautions, and/or contraindications.
(6) Sterility and shelf-life testing for the device must demonstrate the sterility of patient contacting components and the shelf life of these components.