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Aveli is indicated for long-term reduction in the appearance of cellulite in the buttocks and thigh areas as supported by clinical data demonstrating treatment benefits through one year of observation. Avéli is also indicated for soft tissue dissection during general and plastic surgical procedures.

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. Avéli also dissects soft tissue in general and plastic surgical procedures. 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 Blade and a Blocker forming a Hook. When the Handle is moved in a retrograde fashion, the Hook captures the nearby septa or other soft tissue resulting in tugging. The user feels the resistance, confirming that septa under a cellulite depression or other treatment area 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 soft tissue. The user then retracts the Blocker into the device, allowing removal without further tissue engagement. The user can verify all appropriate soft tissue has been released by passing through the area again with the Hook. The step is repeated for each visible cellulite depression or other surgical area.

The provided text describes the Avéli device, which is indicated for long-term reduction in the appearance of cellulite and for soft tissue dissection. The 510(k) submission (K232153) is to expand the indications of use to include soft tissue dissection during general and plastic surgical procedures.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the expanded indication of "soft tissue dissection during general and plastic surgical procedures" in the same format as a table with reported device performance against specific numerical targets.

Instead, it lists types of verification testing conducted to support the substantial equivalence determination for this expanded indication. The conclusion states that "Performance test data demonstrates sufficient performance for soft tissue dissection." This implies that the device met internal design specifications and performance requirements for the soft tissue dissection function.

Here's a summary of the types of performance testing that serve as the basis for demonstrating compliance for the soft tissue dissection indication:

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the sample sizes used for the various non-clinical verification tests (e.g., number of devices tested for functional, mechanical, or electrical tests). It only lists the types of tests performed.

The document also does not provide any information about the provenance of data (e.g., country of origin, retrospective or prospective) for these non-clinical tests. These are typically internal lab tests conducted by the manufacturer.

For the initial indication of "long-term reduction in the appearance of cellulite in the buttocks and thigh areas," the text states it is "supported by clinical data demonstrating treatment benefits through one year of observation." However, details on this clinical data (sample size, provenance, study design) are not provided within this document specifically for the cellulite indication. This submission focuses on the expanded indication for soft tissue dissection which is supported by non-clinical testing for substantial equivalence to a predicate device.

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 document. The tests described are non-clinical verification tests, which typically involve laboratory measurements and assessments against engineering specifications, rather than expert-derived ground truth in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not provided. Given that the tests listed are non-clinical engineering and performance tests, an "adjudication method" in the sense of resolving disagreements among expert reviewers of test data is not typically applicable or described in this type of summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No MRMC comparative effectiveness study is mentioned for the expanded indication of soft tissue dissection. The review pathway is based on substantial equivalence to predicate devices through non-clinical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The Avéli device is a powered surgical instrument used by a human operator, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable. The performance is inherently human-in-the-loop.

7. The Type of Ground Truth Used

For the expanded indication of soft tissue dissection, the "ground truth" for the non-clinical tests is represented by the design specifications, performance requirements, and relevant international standards (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility, ISO 11135-1 for sterilization) that the device was tested against. The tests verify that the device performs as intended and meets these established engineering and regulatory benchmarks.

For the cellulite indication, the ground truth would likely have been based on clinical assessment of appearance reduction (e.g., by investigators or independent evaluators) as stated by "clinical data demonstrating treatment benefits." However, the details of this ground truth establishment are not provided here.

8. The Sample Size for the Training Set

No training set is mentioned in the context of this device. The Avéli is a physical surgical instrument, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for this device.

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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

Study Details

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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).

7. 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.

8. 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.

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