(88 days)
Avéli is indicated for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating treatment benefits through one year of observation.
Avéli is a sterile, single-use manual instrument that releases fibrous tissue (septa) beneath cellulite for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females. The device consists of a Handle and a Distal End. The Handle houses components used to actuate the moving parts at the distal end of the device. The Distal End is advanced into subcutaneous tissue through a small incision to a procedure location. An integrated light source provides illumination and allows the user to track and advance to the procedure location. The Distal End contains a Blocker forming a Hook. When the Handle is moved in a retrograde fashion, the Hook next to fibrous septa captures the septa resulting in tugging. The user feels the resistance, confirming that septa under a cellulite depression have been identified and then exposes the Blade at the Distal End. The user pushes the skin distally with the free hand while maintaining the device stable or applies additional retrograde motion with the device to release the fibrous septa. The user then retracts the Blocker into the device, allowing removal without further tissue engagement. The user can verify all contributing septa have been released by passing through the area again with the Hook. The step is repeated for each visible cellulite depression.
Here's a summary of the acceptance criteria and study details for the Avéli device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: No unanticipated adverse device effects (UADE), related serious adverse events (SAE), nor severe adverse events at 30 days. | Achieved. No device-related SAEs at 30 days. Three adverse device effects (ADEs) occurred in two participants: extended incision, skin laceration, and small scar from laceration, which are typical for this mechanism. Most common AEs were ecchymosis (86.8%), tenderness (51.5%), pain (38.2%), induration (36.8%), and numbness (17.6%), generally mild and transient. |
| Effectiveness: Mean change (improvement) in the Cellulite Severity Score (CSS) is more than 1 for the study population at 3 months. | Achieved. The primary effectiveness endpoint was met, demonstrating a clinically significant improvement in the appearance of cellulite. CSS evaluations at 6 and 12 months showed durability through one year. |
| Durability: Treatment benefits sustained through one year of observation. | Demonstrated through CSS evaluations and clinical data showing long-term reduction in the appearance of cellulite for one year. |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: 74 participants.
- Data Provenance: Prospective, multi-center study conducted across nine (9) investigational sites in the US and Australia.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Three (3) independent physician evaluators.
- Qualifications: The text states they were "independent physician evaluators." Further specific qualifications (e.g., years of experience, specialization) are not provided in the document.
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Adjudication method for the test set:
- The three independent physician evaluators were "individually trained, and monitored throughout the evaluation." They were provided blinded before (baseline) and after photographs side by side in randomized orientation (L-R) and asked to identify baseline/after photos and rate improvement using GAIS and CSS. The document states "All reliability and repeatability measures were met at 3 months and validated the methodology." This implies a consensus or agreement was reached amongst the evaluators, but the specific adjudication rule (e.g., majority vote, specific statistical agreement threshold) 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. This was a clinical study evaluating the device's effectiveness in patients, with independent physician evaluators assessing photographs of those patients. It was not an MRMC study comparing human readers with and without AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. The Avéli device is a manual surgical instrument. The study evaluated its clinical performance in patients, with human physician evaluators assessing the outcomes. There is no mention of an algorithm or AI component.
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The type of ground truth used:
- Expert Consensus/Independent Assessment: The primary effectiveness endpoint was determined by "independent, blinded physician evaluators comparing baseline and 3-month photos" using the Cellulite Severity Score (CSS) and Global Aesthetic Improvement Scale (GAIS).
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The sample size for the training set:
- The document describes a pivotal clinical study and does not mention a separate "training set" for an algorithm. The 74 participants were part of the clinical study to evaluate the device itself.
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How the ground truth for the training set was established:
- Not applicable, as no algorithm training set is described. The clinical study's ground truth was established by independent physician evaluators as detailed above.
§ 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.