(58 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 through five years of observation.
The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The system consists of a sterile, single-use, disposable kit (CK1) and an electromechanical, non-sterile, 50-use motor module (CM1).
Here's a breakdown of the acceptance criteria and study details for The Cellfina System, based on the provided text:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Endpoint) | Reported Device Performance at 5 Years |
|---|---|
| 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 (5 years) after treatment. | The mean improvement was 1.8 points (p60% of treated subjects as determined by independent physician assessment of subject photographs taken before and 5 years after treatment. |
| Primary Safety Result: 100% of subjects free from Serious Adverse Events (SAE) directly attributable to the Cellfina System or procedure at 5 years. | 100% of subjects were free from Serious Adverse Events (SAE) directly attributable to the Cellfina System or procedure at 5 years. (Met) |
| Additional Measures: Mean overall rate of correct selection (likely referring to identification of improvement by independent assessors)100% of subjects had noticeable improvement by the GAIS (Global Aesthetic Improvement Scale)35% of subjects characterized as having "Much Improved" or "Very Much Improved" by GAIS78% of subjects either "Satisfied" or "Very Satisfied"No subjects reported pain in the treatment area using an 11-point numerical rating scale at the 5-year follow-up visit. | The mean overall rate of correct selection was 92.8% with a lower 95% confidence limit of 86.3%. **(Achieved/Acceptable)**100% of the subjects had noticeable improvement by the GAIS. **(Achieved/Acceptable)**35% were characterized as having Much Improved or Very Much Improved. **(Achieved/Acceptable)**78% of the subjects were either Satisfied or Very Satisfied. **(Achieved/Acceptable)**No subjects reported pain in the treatment area using an 11-point numerical rating scale at the 5-year follow-up visit. (Achieved/Acceptable) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
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Sample Size for Test Set:
- 55 subjects participated in the baseline assessment and treatment.
- Follow-up progressively decreased: 3 Day (55), 14 Day (54), 1 Month (54), 3 Month (55), 6 Month (52), 1 year (50), 2 year (52), 3 year (45), 5 year (37). The primary and secondary endpoints are reported at 5 years, so the effective sample size for the long-term evaluation is 37.
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Data Provenance:
- Study Design: Prospective, multi-center, non-randomized open label, safety and effectiveness study.
- Country of Origin: Not explicitly stated in the provided text, but "multi-center" implies it was conducted at several clinical sites.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- The text refers to "independent physician assessment" for determining the Cellulite Severity Scale and classifying improvement. However, it does not specify the number of physicians or their specific qualifications (e.g., years of experience, specialty).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- The text states "independent physician assessment." It does not explicitly describe an adjudication method like 2+1 or 3+1 (where multiple readers might assess independently and then a tie-breaker or consensus is used). It implies individual independent assessments were used to determine the Cellulite Severity Scale and photographic improvement.
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 comparing human readers with AI assistance was not done. The Cellfina System is a physical medical device (powered surgical instrument) for treating cellulite, not an AI-powered diagnostic or assistive tool. The assessments described are of the device's clinical efficacy on patients, conducted by physicians.
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. As mentioned, The Cellfina System is a physical medical device, not an algorithm or AI. The study evaluated the device's performance in patients.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for effectiveness was primarily established by independent physician assessment of subject photographs, utilizing a Cellulite Severity Scale and classifying improvement grades.
- For safety, it was based on outcomes data regarding the absence of Serious Adverse Events (SAE) attributable to the device or procedure.
- Additionally, patient-reported outcomes (GAIS, satisfaction, pain levels) were also collected as secondary measures.
8. The sample size for the training set
- The provided document describes a clinical study to evaluate the performance of the Cellfina System. It does not mention a "training set" in the context of an algorithm or AI model development. Therefore, no information is available on a "training set sample size" as this device is not an AI/ML product.
9. How the ground truth for the training set was established
- Since the device is not an AI/ML product, there is no "training set" or "ground truth for the training set" as would be applicable to such products. The clinical study described is for evaluating the device's clinical performance directly.
§ 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.