(66 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 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, 15-use motor module (CM1).
The provided text is related to a 510(k) summary for the Cellfina System and discusses an extension of shelf life and labeling changes. It repeatedly refers to the predicate device (K150505) for clinical trial data and other non-clinical tests. Therefore, the details regarding acceptance criteria and the study proving the device meets those criteria are primarily found by referencing the K150505 submission, which is not fully included in this document.
However, based on the information provided in the current document (K153677) and the references within it, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The provided document (K153677) is a Special 510(k) for a shelf-life extension and labeling changes. It states that the clinical effectiveness and safety data from the predicate device (K150505) are applicable. Thus, the acceptance criteria for the effectiveness of the device are derived from the clinical data demonstrating "long term improvement in the appearance of cellulite... up to 2 years of observation" as stated in the Indications for Use.
For the specific changes submitted in K153677 (shelf-life extension), the acceptance criteria are related to the stability and performance of the device after aging. The document states:
| Acceptance Criteria (for K153677, focusing on shelf-life) | Reported Device Performance (from K153677) |
|---|---|
| CK1 disposable kit shelf life stability | "ship testing, simulated use, structural integrity, verification of physical characteristics and primary functionality on 12 month aged product demonstrates that the CK1 disposable kit is stable out to 12 months of shelf life." |
| Compliance with electrical safety standards | "The subject device... was tested to IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) and was found to be in compliance with the requirements of this standard." |
Note on Clinical Performance from Predicate Device (K150505) as inferred from Indications for Use:
| Acceptance Criteria (for device effectiveness as per K150505) | Reported Device Performance (Inferred from Indications for Use) |
|---|---|
| Long term improvement in the appearance of cellulite | "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 years of observation." |
2. Sample size used for the test set and the data provenance
The current document (K153677) does not provide this information directly as it refers to the predicate device (K150505) for "in-vivo evaluation (clinical trial data)". For the shelf-life extension, the "test set" for performance evaluation consists of "12 month aged product" for the CK1 disposable kit. The sample size for this testing is not specified. The data provenance for the clinical trial would be available in the K150505 submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the K153677 document, as it defers to the predicate device (K150505) for clinical data. The clinical trial data for the original device approval would have involved assessments by qualified medical professionals (e.g., dermatologists, plastic surgeons) to determine the improvement in cellulite appearance.
4. Adjudication method for the test set
This information is not explicitly provided in the K153677 document. The adjudication method for assessing clinical outcomes (e.g., improvement in cellulite appearance) would have been specified in the clinical trial protocol referenced in the K150505 submission.
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
This is not applicable. The Cellfina System is a powered surgical instrument for treating cellulite, not an AI-assisted diagnostic or imaging device used by "readers." Therefore, a MRMC study involving "human readers" and "AI assistance" would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The Cellfina System is a physical device used by a physician (human-in-the-loop) to perform a surgical procedure. It is not an algorithm performing a task without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical effectiveness of the device (as inferred from K150505 via the Indications for Use), the ground truth for "improvement in the appearance of cellulite" would likely be based on:
- Expert assessment: Clinical evaluators (e.g., physicians) making subjective and/or objective assessments of cellulite severity before and after treatment.
- Patient outcomes data: Patient satisfaction and self-assessment of their cellulite appearance.
- Possibly photographic evidence: Standardized photographs evaluated by blinded experts.
For the shelf-life extension (K153677), the ground truth is based on engineering and performance testing to ensure the device components meet specifications after aging.
8. The sample size for the training set
This is not applicable in the context of an algorithm training set, as the Cellfina System is a medical device for direct treatment, not an AI/ML model being trained. If "training set" refers to the subjects in the original clinical study (K150505), that information is not provided here.
9. How the ground truth for the training set was established
Not applicable for the same reasons as point 8.
§ 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.