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The Erchonia EVRL is intended to emit energy in the red and blue region of the spectrum, and is specifically indicated to treat mild to moderate acne.

The Erchonia EVRL is a compact, handheld device designed to reduce the appearance of mild to moderate acne. It emits visible blue light at a 405nm wavelength and red light at 640nm, both with a ±10nm tolerance.

The EVRL device provides a non-thermal and non-contact treatment, designed for use approximately one to three inches from the skin without direct contact. It features an intuitive touchscreen interface with a preset acne treatment protocol, activated by a press-to-start button for ease of operation. A built-in visual countdown timer and audible treatment indicator "beep" assist the user during treatment, and the device automatically powers off upon completion of the treatment cycle. The wavelength and power settings are factory-set and cannot be modified by the user.

The Erchonia EVRL has been classified by the FDA as a Class II device. The testing of the Erchonia EVRL device includes functional performance, electrical, safety and component verification, in accordance with the FDA QS requirement. The software incorporated into the operation of the Erchonia EVRL complies with FDA and ISO Software Development and Validation regulations.

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a. while using the red 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® EVRL (Model# EVRL) is a low-level laser system that uses two semi-conductor diodes (visible red and violet light), red: 630-650 nm and violet: 380-450 nm. The Erchonia® EVRL (Model# EVRL) is a variable hertz device. The variable hertz feature of the Erchonia® EVRL (Model# EVRL) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® EVRL (Model# EVRL) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser.

The Erchonia® EVRL (Model# EVRL) is indicated for use:

a. while using the red 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® Laser is applied externally and has proven through clinical trials to treat neck and shoulder pain with the red diode.

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 640 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 red 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 inout 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 Erchonia® EVRL (Model# EVRL) 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. The protocols consist of activating the lasers to emit predefined frequencies for a predetermined length of time.

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 .

The provided text describes a 510(k) premarket notification for the Erchonia® EVRL device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (the same model, K152196) and presents clinical data to support the device's expanded indication for use in relieving neck and shoulder pain.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission appear to be centered around demonstrating non-inferiority or superiority of the Erchonia® EVRL when using both red and violet diodes simultaneously for neck and shoulder pain, compared to the previously cleared red diode only application.

Study Details:

1. A table of acceptance criteria and the reported device performance: Included above.

2. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: 44 subjects completed the study for the investigational device arm. Data from 43 subjects from a previous 2001 trial served as the comparative "active control" (red diode only).
   • Data Provenance: The document does not explicitly state the country of origin. The study was conducted at "the investigator's test site." Given the FDA context and the company's address in Florida, USA, it's reasonable to infer a US-based study, but this is not explicitly stated. The present study was prospective, comparing its results to a retrospective re-analysis of a prior clinical trial (the 2001 trial).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The clinical study used patient-reported outcomes (Visual Analog Scale for pain, and satisfaction ratings) and objective physical measurements (Range of Motion) as its primary and secondary endpoints.

   • No external "experts" were used to establish ground truth in the sense of image annotation or disease diagnosis for a test set. The ground truth for this study was the patient's own perception of pain (VAS score) and measured physical range of motion.
   • The "investigator" is mentioned as administering the procedure, but their qualifications are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   The study design involved direct measurement of patient pain (VAS) and range of motion. There was no "adjudication" in the sense of multiple readers or experts reviewing data for consensus, as would be common in image-based diagnostic studies. The "ground truth" was directly reported by the patient or measured.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   No MRMC study was done. This study is not an AI-assisted diagnostic study involving human readers. It is a clinical trial assessing the effectiveness of a physical therapy device (low-level laser). Therefore, this question is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   No, this is not applicable. This device is a physical therapy laser, not an algorithm. Its performance is directly tied to its physical application by a user.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth was based on patient-reported outcomes data (Visual Analog Scale for pain, satisfaction ratings) and objective physical measurements (range of motion). The study criteria for "success" were a 30% or greater decrease in VAS rating.

8. The sample size for the training set:
   Not applicable. This document describes a clinical study for a medical device (laser), not a machine learning model; therefore, there is no "training set" in the AI/ML sense. The "training" for the device's effectiveness occurred through its design and empirical testing in clinical trials.

9. How the ground truth for the training set was established:
   Not applicable. See point 8.

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The Erchonia® EVRL laser is generally indicated: a. while using the red diode, 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.

Erchonia® EVRL laser

I apologize, but the provided text from the FDA 510(k) summary for the Erchonia EVRL laser does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria for medical imaging or AI applications.

The document is a letter from the FDA stating that the Erchonia EVRL laser is substantially equivalent to legally marketed predicate devices for its stated indications for use (temporary relief of minor chronic neck and shoulder pain, and treatment of moderate inflammatory Acne Vulgaris).

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance using the provided text. The information points you requested (e.g., sample size, expert qualifications, MRMC study, ground truth) are relevant to the evaluation of AI/imaging devices, but are not present in this regulatory correspondence for a laser therapy device.

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The Erchonia EVRL Laser is generally indicated:

• while using the red diode, for adjunctive use in providing temporary relief of a. minor chronic neck and shoulder pain of musculoskeletal origin, and
• b. while using the blue diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

Erchonia EVRL Laser

This is an incredibly difficult request, as the provided document is a 510(k) clearance letter from the FDA, not a study report or clinical trial results.

A 510(k) clearance signifies that the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device, essentially meaning it's as safe and effective as a device already on the market. It does not present the original study data, acceptance criteria, or performance metrics in the format requested.

Therefore, I cannot directly extract the detailed information requested regarding acceptance criteria and performance data for the Erchonia EVRL Laser from this specific document.

However, I can explain why I cannot provide the information from this document and what kind of document would contain it:

• Acceptance Criteria and Reported Device Performance (Table): This information would be found in a clinical study report submitted as part of the 510(k) application, or detailed within the substantial equivalence comparison to the predicate device. The clearance letter itself does not contain these details.

• Sample Size (Test Set) and Data Provenance: This would also be in the clinical study report. The 510(k) letter only indicates the clearance and the date it was received.

• Number and Qualifications of Experts for Ground Truth: This level of detail about ground truth establishment is specifically found within the methodology section of a clinical study report.

• Adjudication Method: Similar to the above, this would be described in the study's methods.

• MRMC Comparative Effectiveness Study: If such a study were performed, its design, methodology, and results (including effect size) would be elaborated in a separate study report. The 510(k) clearance letter does not include this. Given the device's indications, it's unlikely an MRMC study related to human readers would be highly relevant, as it's a laser for pain and acne, not an imaging diagnostic tool.

• Standalone Performance: The 510(k) clearance focuses on substantial equivalence. If standalone performance data was generated, it would be in a study report.

• Type of Ground Truth: The method for establishing ground truth (e.g., expert consensus, pathology, outcome data) would be detailed in the study report. For pain relief, ground truth might involve patient-reported pain scores or physician assessment. For acne, it might involve lesion counts or global assessment scales.

• Sample Size for Training Set: This is typically relevant for machine learning algorithms. While the Erchonia EVRL is a laser device (not explicitly an AI/ML device based on this document), if there were any AI components involved in its use or assessment, that data would be in an AI/ML specific technical report or a clinical study report.

• How Ground Truth for Training Set was Established: Again, this relates to AI/ML development and would be in a technical report or study protocol.

In summary, to answer your request comprehensively, I would need access to the full 510(k) submission, specifically the clinical study reports or summaries of the studies conducted to demonstrate substantial equivalence.

The provided document (K050672) is merely the FDA's decision letter.

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