(86 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 3 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 an analysis of the provided text to extract the acceptance criteria and study details for "The Cellfina System":
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Endpoint/Measure) | Reported Device Performance at 3 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. | The primary endpoint was met: The average improvement was **2.0 points (p60% of treated subjects as determined by independent physician assessment of subject photographs. |
| Primary Safety Endpoint: 100% of subjects free from Serious Adverse Events (SAE) directly attributable to the Cellfina System or procedure. | The safety endpoint was met: 100% of subjects were free from Serious Adverse Events (SAE) directly attributable to the Cellfina System or procedure. |
| Additional Secondary Measure (Rate of Correct Selection): (Implicit, likely referring to identification of affected areas/response to treatment) | The average rate of correct selection was 97% with a 95% confidence limit of 92.6%. |
| Additional Secondary Measure (Noticeable Improvement by GAIS): | 100% of the subjects had noticeable improvement by the GAIS. |
| Additional Secondary Measure (Marked Improvement or Better by GAIS): | 56% were characterized as having marked improvement or better. |
| Additional Secondary Measure (Subject Satisfaction): Percentage of subjects either satisfied or very satisfied. | 93% of the subjects were either satisfied or very satisfied as evaluated by a 5-point Likert type scale. |
| Additional Secondary Measure (Pain Level): Percentage of subjects rating pain ≤3/10. | 71% of subjects rated pain ≤ 3/10 at 3 days, and over 95% rated pain ≤ 3/10 thereafter. There were no subjects who reported pain at the 3-year follow-up. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 55 subjects participated in the baseline assessment and treatment.
- Follow-up at 3 years: 45 subjects completed the 3-year follow-up.
- Data Provenance: The study was a "Prospective, multi-center, non-randomized open label, safety and effectiveness study." This indicates it was a prospective study, typically conducted in multiple clinical sites (country of origin is not explicitly stated, but often such trials for FDA approval are largely US-based unless otherwise specified).
- Imputation: For the 10 subjects lost to follow-up at 3 years, "last observation carried forward (LOCF)" was used for both primary and 1st secondary endpoints, and "multiple imputation" for the primary effectiveness endpoint.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The primary and secondary endpoints were determined by "independent physician assessment of subject photographs." The exact number of independent physicians (experts) is not specified in the provided text. Their specific qualifications (e.g., "radiologist with 10 years of experience") are also not detailed, beyond being "independent physicians."
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The adjudication method is not explicitly described in the provided text. It only mentions "independent physician assessment." This could imply a single independent assessor or a consensus method, but the specific process (e.g., if multiple physicians' assessments were averaged or if a tie-breaking mechanism was used) is not detailed.
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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 was not done. This study evaluates a device (The Cellfina System) for treating cellulite, not an AI or imaging diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this device is a powered surgical instrument, not an algorithm. The performance detailed here is for the physical device and procedure, with human physicians performing the assessment.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for effectiveness was established primarily through expert assessment/consensus based on photographs ("independent physician assessment of subject photographs").
- Safety was based on outcomes data (absence of Serious Adverse Events reported).
- Subject satisfaction and pain levels were based on patient-reported outcomes.
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The sample size for the training set:
- Not applicable. This study is for a medical device (a powered surgical instrument), not a machine learning model. There is no concept of a "training set" in this context. The clinical study described served as the validation and effectiveness study for the device itself.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for a medical device of this nature.
§ 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.