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The Erchonia® Emerald (Model # SHL) Laser is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) up to 40 kg/m².

The Erchonia® Emerald (Model#: SHL) is low-level laser system that uses ten (10) semi-conductor diodes (visible green-light) 522nm to 542nm. The Erchonia® Emerald (Model#: SHL) has been classified by the FDA as a Class II device and a Class II Laser in accordance with IEC 60825-1 (Complies with 21 CFR 1040.10 and 21 CFR 1040.11 by laser notice #50. The performance parameters and intended use of the Erchonia® Emerald (Model#: SHL) are compliant to the internationally recognized safety testing standards for medical devices. The Erchonia® Emerald (Model#: SHL) device includes functional performance, electrical, safety and component verification, in accordance with the FDA QS requirement, validated annually through ISO 13485 and MDSAP audits. The software incorporated into the operation of the Erchonia® Emerald (Model#: SHL) complies with FDA and ISO Software Development and Validation regulations.

The components of the device include a mobile base that plugs into the wall, using a hospital grade power cord, equipped with a medical-grade transformer. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to mains power. Four (4) antistatic wheels that enable ease for maneuverability. 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 laser diodes can only be on or off; there is no user interface that allows the end-user to alter the laser diode output. The protocol is factory set and cannot be altered by the end-user. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the laser head assembly that is attached to the adjustable main arm utilizes internal mechanics that collects the light emitted from each of the ten (10) laser diodes that rotate in a spiraling circle pattern that is totally random and independent of the other diodes. The laser head assembly can be manually adjusted for positioning the lasers 3-4 inches from the patient's skin to deliver treatment for body contouring. The device laser head assembly can be moved vertically (raised or lowered) over the subject for proper height placement of lasers for treatment. The device laser head assembly can be moved horizontally (left or right) over the patient for proper placement of lasers for treatment. The device laser head assembly has two adjustable outside laser arms with each arm housing two (2) laser diodes that can be moved in and out for proper positioning to the patient for accurate treatment distance.

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 provided text describes the Erchonia Emerald (Model # SHL) Laser, a low-level laser system intended for non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) up to 40 kg/m².

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Erchonia Emerald Laser are based on its substantial equivalence to predicate devices, which were proven safe and effective through clinical trials. The reported device performance is therefore inferred from the performance of these predicate devices.

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

The submission explicitly states: "Erchonia Corporation did not perform a clinical study for the indication for use proposed in this premarket notification. Substantial equivalence is based on the primary predicate device, the Erchonia® SHL Laser (Model# SHL) K142042, as well as the secondary predicate device, the Erchonia® Zerona™ 2.0 Laser (Model# GLS) K123237."

Therefore, there is no new test set data generated for the Erchonia Emerald device itself to directly prove its acceptance criteria. The data provenance is from the clinical trials conducted for the predicate devices. The document does not specify the sample sizes or country of origin for the predicate device studies.

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

Since no new clinical study was conducted for the Erchonia Emerald, this information is not available in the provided text. The ground truth for the predicate devices' clinical trials would have been established by clinical outcomes and measurements, typically interpreted by qualified medical professionals.

4. Adjudication Method for the Test Set

As no new clinical study was performed for the Erchonia Emerald, there's no adjudication method described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done for the Erchonia Emerald Laser as no new clinical study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a physical laser system, not an algorithm, so the concept of a "standalone algorithm" performance study is not applicable.

7. Type of Ground Truth Used

The ground truth for the performance claims is based on the clinical outcomes data from the clinical trials performed for the predicate devices (Erchonia® SHL Laser K142042 and Erchonia® Zerona™ 2.0 Laser K123237). These trials demonstrated the safety and effectiveness of those devices in reducing body circumference.

8. Sample Size for the Training Set

As this is a physical medical device and not an AI/ML algorithm that requires a "training set" in the computational sense, this concept is not applicable. The device's design and operation are based on established scientific principles of low-level laser therapy and its equivalence to previously cleared devices.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this device. The efficacy and safety are established via substantial equivalence to predicate devices that underwent clinical trials.

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