(154 days)
The Cellfina™ 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 2 vears of observation.
The Cellfina System is 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 of manual surgical instruments and accessories. The Cellfina device consists of a powered cutting blade and a means for instrument guidance to control the depth, size and shape of the tissue release. The system consists of a sterile single use disposable kit and a non-sterile reusable motor module.
The provided text describes specific acceptance criteria and performance data for the Cellfina™ System, a device intended for the improvement of the appearance of cellulite.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Primary Endpoints) | Reported Device Performance (2-year follow-up) |
|---|---|
| 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 2 years after treatment. | The average improvement was 2.0 points (p60% of treated subjects as determined by independent physician assessment of subject photographs taken before and 2 years after treatment. |
| Freedom from Serious Adverse Events (SAE) directly attributable to the Cellfina™ System or procedure. | 100% of subjects were free from Serious Adverse Events (SAE) directly attributable to the Cellfina™ System or procedure. (Met) |
Additional Secondary Measures Achieved:
- Correct Selection by Independent Physician Assessment: Average rate of correct selection of blinded subject photographs (before and two years after treatment) was 98.1% (95% confidence limit of 94.5%).
- Noticeable Improvement (GAIS) and Marked Improvement: 100% of subjects had noticeable improvement by the Global Aesthetic Improvement Scale (GAIS). 52% were characterized as having marked improvement or better by independent physician assessment.
- Subject Satisfaction: 96% of subjects were either satisfied or very satisfied at the 2-year follow-up.
- Subject Reported Pain: Average pain on a 0-10 numerical rating scale was 4.5 for anesthesia delivery and 3.7 for tissue release. At follow-ups, 71% of subjects rated pain ≤ 3 at 3 days, and over 95% rated pain ≤ 3 thereafter. No subjects reported pain at the 2-year follow-up.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document indicates that "All subjects served as their own control" and mentions endpoints being achieved for "all subjects." However, the exact number of subjects in the pivotal clinical study (test set) is not explicitly stated in the provided text.
- Data Provenance: The study was a "prospective, multi-center, non-randomized open label, safety and effectiveness study." The location (country of origin) of the study centers is not specified, but it was conducted under IDE G120116.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: An "independent and blinded reviewer of the photographs" was used to verify effectiveness, and "independent physician assessment" determined the reduction in cellulite severity and grade improvement. The exact number of independent physicians/reviewers is not specified.
- Qualifications of Experts: The text refers to "independent physician assessment." No further details on their specific qualifications (e.g., specialty, years of experience) are provided.
4. Adjudication method for the test set
- The document mentions an "independent and blinded reviewer" for photographs to verify effectiveness. For the primary and powered secondary endpoints, "independent physician assessment" was used. The text does not explicitly detail an adjudication method (e.g., 2+1, 3+1) if there were multiple independent assessments or if there were disagreements. It implies a single "independent physician assessment" for each metric.
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 focusing on AI assistance for human readers was not mentioned. The study evaluated the effectiveness of the Cellfina System itself, not an AI assistant.
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 mentioned. The Cellfina System is a physical device that is used by physicians, and the study evaluated its direct clinical performance on patients.
7. The type of ground truth used
- The ground truth was established through expert consensus/assessment of clinical data. This included:
- Independent physician assessment of subject photographs (before and 2 years after treatment) for cellulite severity and grade improvement.
- Global Aesthetic Improvement Scale (GAIS) based on independent physician assessment.
- Subject-reported satisfaction and pain levels.
- Adverse event reporting.
8. The sample size for the training set
- The text does not mention a separate "training set" in the context of device development or any machine learning/AI models. The clinical study described is a pivotal trial evaluating the device's safety and efficacy.
9. How the ground truth for the training set was established
- As no "training set" (in the context of AI/machine learning) is described, this question is not applicable based on the provided text. The clinical study described served as the basis for demonstrating the device's effectiveness.
§ 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.