(60 days)
The Violet ZERONA® Z6 OTC is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.
The Violet ZERONA® Z6 OTC laser is designed for client's seeking noninvasive circumference reduction without invasive surgery. Violet ZERONA® Z6 OTC allows the patient to continue their daily activities without interruptions from surgery, pain, wounds or garments. The Violet ZERONA® Z6 OTC works by emulsifying adipose tissue which then releases into the interstitial space. The Violet ZERONA® Z6 was built on the clinical foundation of its predecessors, Zerona® and Zerona®-AD, and ZERONA® Z6 OTC, which were proven through clinical studies to be safe and effective in the application of circumference reduction.
The Erchonia Violet ZERONA® Z6 OTC is identical to the predecessor device, the Erchonia ZERONA® Z6 OTC cleared under K162578, with the differences being light output (visible violet compared to visible red) and duration of treatment administrations (20 minutes compared to 40 minutes, which is automatically programmed into the device). The Installation and Proper Use Reference Guide for use for the Erchonia® Violet ZERONA® Z6 OTC are identical to those for use of the predecessor laser, the Erchonia® ZERONA® Z6 OTC; consisting of the same device set-up and same treatment protocol involving 6 treatments occurring over 2 weeks: 3 treatments per week; each treatment every other day.
The Violet ZERONA® Z6 OTC emits a 405-nanometer wavelength with a tolerance of ±10 nanometer, from each of the six specially created and patented electronic diodes. Laser devices are typically constructed to emit a "spot" of light. The Violet ZERONA® Z6 OTC laser utilizes internal mechanics that collects the light emitted from the laser diode and processes it through a proprietary patented lens, and then redirects the beam with a line refractor. The laser applicator heads, each produce an output power of 23mW (± 2mW) measured. Laser diodes and adjustable laser arms are positioned no greater than 3-4 inches away from the client's target treatment areas.
The software incorporated into the operation of the Violet ZERONA® Z6 OTC complies with FDA and ISO Software Development and Validation regulations.
Here's an analysis of the acceptance criteria and the study proving device performance, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Pre-specified Success Threshold) | Reported Device Performance (Mean Change) | Device Performance vs. Criterion |
|---|---|---|
| Mean change in combined circumference measurements of -3.72 ± 5% inches (-3.53 to -3.91 inches) | -3.91 inches (95% CI: 3.26 - 4.56) | Exceeded lower boundary of -3.53 inches and fell within the acceptable range (-3.53 to -3.91 inches) |
| Safety: No adverse events | No adverse events reported or observed | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 25 subjects completed the study.
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was an "open-label single-arm design" clinical study, which implies it was prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This device focuses on biometric measurements (circumference reduction) rather than image interpretation or diagnosis. Therefore, there is no mention of "experts" being used to establish ground truth in the traditional sense of medical imaging or diagnostic devices. The ground truth (circumference measurements) would have been taken by trained study personnel using standardized methods. Their qualifications are not specified but are implied to be sufficient for accurate measurement taking.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this device does not involve subjective interpretations requiring adjudication by experts. Measurements would have been taken according to a defined protocol.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This study did not involve human readers interpreting cases with and without AI assistance. It was a clinical study evaluating the efficacy of a laser device for circumference reduction.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not directly applicable to this device, as it is a physical laser device applied to a patient, not an AI algorithm performing analysis. The study assessed the device's performance directly on human subjects.
7. Type of Ground Truth Used
The ground truth used was biometric measurements of body circumference (waist-hips-bilateral thighs circumference) taken directly from subjects at baseline and at the study endpoint.
8. Sample Size for the Training Set
This document does not describe the development or training of an algorithm in the traditional sense that would require a dedicated training set. The "clinical foundation" of the device was built upon predecessors, and this study served as a validation study for the new violet laser, comparing its performance to historical data from the red laser. The predicate device (Erchonia ZERONA® Z6 OTC) had a clinical study (K162578 and K143007) that involved 22 subjects (as seen in Table 1). This could be considered a comparative dataset, but not a "training set" for an algorithm in this context.
9. How the Ground Truth for the Training Set Was Established
As explained above, there isn't a "training set" in the context of an AI algorithm described here. The previous studies (K162578, K143007) that established the efficacy of the red laser (which the violet laser is compared against) would have established their ground truth through similar direct biometric measurements of circumference reduction on their respective subject cohorts.
§ 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.