Search Results
Found 1 results
510(k) Data Aggregation
(105 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Endpoint: Achievement of ≥1 point average reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 1 year after treatment. | **Average improvement was 2.0 points (p60% of treated subjects as determined by independent physician assessment of subject photographs taken before and 1 year after treatment. |
| Additional Secondary Measures: | |
| - Average rate of correct selection by independent physician assessment of blinded subject photographs taken before and 1 year after treatment. | - 99% accurate selection. (Achieved or Acceptable) |
| - Percentage of subjects with noticeable improvement in the Global Aesthetic Improvement Scale (GAIS) and percentage characterized as having marked improvement or better by independent physician assessment of blinded subject photographs taken before and 1 year after treatment. | - 100% of subjects had noticeable improvement in GAIS. |
| - 72% were characterized as having marked improvement or better. (Achieved or Acceptable) | |
| - Percentage of subjects satisfied or very satisfied at the 1-year follow-up, as evaluated by a 5-point Likert type scale. | - 94% of subjects were either satisfied or very satisfied. (Achieved or Acceptable) |
| - Subject reported pain on a 0-10 numerical rating scale. | - Pain for anesthesia delivery: 4.5. |
| - Pain for tissue release: 3.7. | |
| - Follow-up pain: 71% of subjects rated pain ≤ 3 at 3 days; over 95% rated pain ≤ 3 thereafter; no subjects reported pain at 1 year. (Achieved or Acceptable) | |
| Primary Safety Endpoint: Freedom from serious adverse events attributable to the Cabochon procedure or device for all subjects (100%). | Achieved for all subjects (100%). (Met) |
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.
Ask a specific question about this device
Page 1 of 1