(132 days)
The Vevazz LED can be used to provide the non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
The Vevazz is a non-invasive red-light system. The device is a moderately complex device that consists of a base unit that plugs into 120 VAC or 240 VAC main power with Ground (earth) and a 2 amp 250 VAC Fuse. The base unit can support up to 16 large LED paddles and 4 small LED paddles. The connections on the base are female phono jacks that are low voltage having a maximum electrical output of 16 VDC @ .5 amps for a total of 8 Watts per port. The large paddles consist of 28 LEDs in a series/parallel electrical connection that has a cord with a male phono jack. Small paddles consist of 4 LEDs and have matching electrical characteristics as the large paddles. Each LED produces 50 mw/cm2 of light energy with a wavelength of 650 nm; +/- 25 nm uniformly over the treatment area without producing hot spots. Treatment time is preset to 7 minutes for non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
Acceptance Criteria and Study for Vevazz LED
This document outlines the acceptance criteria and the study conducted to demonstrate the Vevazz LED device's performance for the non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the Vevazz LED device was demonstrated through substantial equivalence to a predicate device, the Photonica Professional (K160880). The key performance metric was the "combined circumferential reduction of the waist, hips, and thighs" after a single treatment session.
| Acceptance Criterion | Reported Device Performance (Vevazz LED) | Predicate Device Performance (Photonica Professional) |
|---|---|---|
| Substantial equivalence to predicate device in achieving combined circumferential reduction of waist, hips, and thighs. | Average combined circumferential reduction: 2.5 inches (from a single 28-minute treatment session) |
100% of patients had clinically significant results, losing at least 1.0 inch.
Breakdown by Gender:
- Males (13 patients): 1 5/8 inches
- Females (64 patients): 2 2/5 inches
Breakdown by Study Site (average inch loss across 4 sites):
- Site A (8 patients): 3 4/7 inches
- Site B (16 patients): 1 2/3 inches
- Site C (23 patients): 2 1/2 inches
- Site D (30 patients): 2 1/6 inches
Minimum inch loss observed: 1 inch
Maximum inch loss observed: 7 1/2 inches | Average combined circumferential reduction: 3.5 inches (from one 32-minute treatment) |
| Treatment time | 28 minutes (four 7-minute exposures) | 32 minutes (four 8-minute treatments) |
| Safety: No device-related adverse events | No device-related adverse events were reported. | Not explicitly stated for predicate in provided text, but assumed to be safe as per FDA clearance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 77 patients (64 female, 13 male)
- Data Provenance: Retrospective analysis of existing treatment records from multiple private practice locations in the USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not specify the number of experts used or their qualifications for establishing ground truth measurements in the retrospective analysis. It notes that "measurements were taken in exact accordance with the Photonica Male Measurement Guide. Female Measurement Guide. Male Measurement Form, and Female Measurement Forms as were used in the clinical trials upon which the predication was approved." This suggests reliance on pre-established measurement protocols rather than independent expert adjudication for the retrospective data.
4. Adjudication Method for the Test Set
- The document does not explicitly state an adjudication method (such as 2+1, 3+1). The nature of the retrospective analysis of existing records suggests that measurements were likely taken by clinic staff following standardized protocols at the time of patient treatment, rather than an independent adjudication process for the study itself.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
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No, an MRMC comparative effectiveness study was not done. This study was a retrospective analysis of the Vevazz LED's performance, with a direct comparison of its numerical results (average inch loss) to previously published results from the predicate device (Photonica Professional). It does not involve human readers evaluating cases with or without AI assistance.
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Effect Size of Human Readers with AI vs. without AI Assistance: Not applicable, as this was not an MRMC study comparing human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone study was done in the sense that the Vevazz LED device itself (without direct human interpretive aid for results) was evaluated for its efficacy. The "performance" being measured is the physical effect of the device on patients (circumferential reduction), not an interpretation of images or data by an algorithm.
7. The Type of Ground Truth Used
- Outcomes Data (Clinical Measurements): The ground truth was established by direct clinical measurements of circumferential reduction (in inches) of the waist, hips, and thighs taken before and immediately after treatment. These measurements were performed using self-tensioning tape measures and adhered to specific measurement guides established for the predicate device's clinical trials.
8. The Sample Size for the Training Set
- The document describes a retrospective analysis of an existing device (Vevazz LED) to demonstrate its performance against a predicate. There is no mention of a "training set" in the context of machine learning or AI algorithms, as this is a physical medical device. The 77 patients' data constitutes the "test set" or clinical evidence for the device's efficacy.
9. How the Ground Truth for the Training Set Was Established
- Since there was no "training set" in the context of an AI/ML algorithm, this question is not applicable. The "ground truth" for the performance evaluation was established through direct pre- and post-treatment physical measurements of patients using standardized protocols.
§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.