(30 days)
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:
| Acceptance Criteria (General Categories based on testing) | Reported Device Performance (Implied by Conclusion) |
|---|---|
| Design Specifications & Functional Performance | Sufficient performance for soft tissue dissection |
| Visual Inspections | Met visual specifications |
| Dimensional Inspections | Met dimensional specifications |
| Functional testing (Simulated use, Force measurements, Tensile testing) | Performed adequately in simulated use, force and tensile tests were within acceptable limits |
| Mechanical testing | Met mechanical performance requirements |
| Electrical testing | Met electrical performance requirements |
| Optical output testing | Provided adequate illumination |
| Safety and Regulatory Compliance | Compliance with relevant standards |
| Electrical Safety Testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6/IEC 62366-1) | Met electrical safety standards |
| Biocompatibility Testing (ISO 10993-1) | Demonstrated biocompatibility |
| Sterilization Validation (ISO 11135-1, ISO 14161) | Sterilization process validated |
| Packaging Validation (ISO 11607-1) | Packaging maintained sterility and integrity |
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.
§ 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.