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The Erchonia® GVL laser is generally indicated:

a. while using the green and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,

b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

The Erchonia® GVL (Model# GVL) is a low-level laser system that uses two semi-conductor diodes (visible green and violet light), green: 520 nm and violet: 405 nm ± 10. The Erchonia® GVL (Model# GVL) is a variable hertz device. The variable hertz feature of the Erchonia® GVL (Model# GVL) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® GVL (Model# GVL) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser.

The components of the device consist of:

An ultra-slim hand-held battery-operated control device with a docking station providing two laser diodes a 520 nanometer and a 405 nanometer. Each laser diode emits its wavelength with a tolerance of ±10 nanometer. The lasers are powered by an internal battery that is recharged using a separate inductive charging base powered by an external class II medical power supply. This configuration offers portability as well as consistency of power.

The internal battery powers the two specially created and patented electronic diodes with an output of 7.5mW ± 1mW green and <5mW violet non-convergent beam and is classified as a Class 2 laser in accordance IEC 60825-1 (Complies with 21CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50). The separate inductive charging base runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power.

A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The Erchonia® GVL (Model# GVL) as designed contains user protocols. The user protocols are defined and saved by the user in one of ten memory locations and can be changed at any time. User instructions are provided in the Erchonia® GVL Operation & Maintenance Manual for proper touchscreen interface operation for the user to set laser diode variable hertz and length of treatment time. There is no interface that allows the end user the laser power output (milliwatts) or the laser wavelength (nanometers).

The Acne protocol is factory set and cannot be altered by the end user.

The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons, work in conjunction with the component platform to ensure the device operates as intended.

The associated accessories include:

• Charging Base .
• Power Supply
• . Patient protective eyewear

This document describes the Erchonia® GVL device, which is an infrared lamp cleared for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin (using green and violet diodes simultaneously) and to treat moderate inflammatory Acne Vulgaris (using the violet diode). The device's substantial equivalency is based on a comparison to the Erchonia® EVRL (predicate device).

Here's the information about the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

For temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin:

Individual subject success was pre-established as a 30% or greater decrease in Visual Analog Scale (VAS) rating at endpoint relative to baseline.

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

The study was a single-group non-inferiority design.

• Test Set Sample Size: 43 subjects completed the study for the Erchonia® GVL device.
• Data Provenance: The document does not explicitly state the country of origin. The study was prospective, as it involved administering the Erchonia® GVL to new subjects. The comparative data for the predicate device (Erchonia® EVRL) was attained from a 2019 trial, which would also be considered prospective at the time it was conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the test set was based on self-reported Visual Analog Scale (VAS) pain ratings from subjects, not expert medical assessment for individual cases. Therefore, this section is not applicable in the traditional sense of medical image or diagnostic device evaluation.

4. Adjudication Method for the Test Set

The adjudication method for the test set (regarding pain relief) was based on individual subject self-reporting of VAS pain ratings, with success defined as a 30% or greater decrease from baseline. There was no mention of an expert adjudication panel.

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

No, an MRMC comparative effectiveness study was not done. The study was a non-inferiority clinical study comparing the device to a previously established predicate device's clinical trial results. The outcome measure (VAS pain rating) is a subjective patient-reported outcome, not an interpretation by multiple readers.

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

This is a physical medical device (laser system), not an algorithm or AI system for diagnosis or interpretation. Therefore, a standalone (algorithm only) performance study is not applicable. The performance evaluated was the direct effect of the device on patients.

7. The Type of Ground Truth Used

The ground truth used for the pain indication was patient-reported outcomes, specifically the change in Visual Analog Scale (VAS) neck and shoulder pain ratings.

8. The Sample Size for the Training Set

The document describes a clinical study for the Erchonia® GVL device. This study is a non-inferiority clinical trial to demonstrate effectiveness, not a study for training an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The clinical data from the Erchonia® EVRL 2019 trial (n=44) and the Erchonia® PL2000/EVRL (K012580, K152196) (n=43) serve as comparative effectiveness data from prior studies, not training data for the subject device's approval.

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

As noted above, there is no "training set" in the machine learning sense for this device. The comparative data (from previous trials for the Erchonia® EVRL and PL2000) also used patient-reported outcomes (VAS pain ratings) as their ground truth for establishing effectiveness.

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