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The Erchonia® XLR8 is generally indicated:
a. as adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin
b. as an adjunct to liposuction procedures of the thighs, hips and stomach for reduction of pain associated with the recovery process
c. for the temporary reduction in post-surgery pain at 24 hours after surgery following bilateral breast augmentation surgery
d. as an adjunctive treatment of postoperative pain

The Erchonia® XLR8 (Model# HLS) is a low-level laser system that uses two semi-conductor diodes (visible red light), red: 640nm ±10. The Erchonia® XLR8 (Model# HLS) is a variable hertz device. The variable hertz feature of the Erchonia® XLR8 (Model# HLS) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® XLR8 (Model# HLS) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser. The Erchonia® Laser is applied externally and has proven through clinical trials to treat post-surgical pain associated with liposuction and breast augmentation surgery. The Erchonia ® XLR8 laser emits a 640-nanometer wavelength with a tolerance of ±10 nanometer, from each of the two laser 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

The document provided describes an FDA 510(k) premarket notification for the Erchonia® XLR8 laser, primarily focusing on expanding its indications for use. It states that the subject device (Erchonia® XLR8 Laser, Model# HLS) is identical to its predicate device (also Erchonia® XLR8 Laser, Model# HLS) previously cleared under K130996. Therefore, no new performance testing (bench, animal, or clinical) was conducted for this specific submission to demonstrate compliance with acceptance criteria for the expanded indication.

Instead, the submission relies on:

1. The substantial equivalence to the previously cleared predicate device, which itself had previously demonstrated substantial equivalence to another predicate (Erchonia EML Laser, K041139, K072206).
2. Supportive published literature on low-level laser therapy (LLLT) to justify the expanded indication for "adjunctive treatment of postoperative pain."

Given this context, the request for specific acceptance criteria and a study demonstrating the device meets those criteria for the current submission cannot be fully answered with new data from this document. The document explicitly states: "No new clinical data is being submitted in this 510(k) submission." and "No clinical study results are being submitted as part of this submission."

However, I can extract the information provided about the device and how the expanded indication is justified.

1. Table of Acceptance Criteria and Reported Device Performance

Since no new performance criteria or clinical study results are provided for this submission for the expanded indication, I will present the key performance characteristics that define the device and how its substantial equivalence to the predicate (which previously met acceptance criteria for its indications) is established. The "acceptance criteria" here implicitly refer to the proven safety and effectiveness of the identical predicate device and the general principles of LLLT supported by literature.

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

• Test Set Sample Size: Not applicable for this specific 510(k) submission, as no new clinical studies were conducted or submitted. The justification for the expanded indication relies on a review of published literature on low-level laser therapy (LLLT).
• Data Provenance: The document states that "Seven randomized controlled clinical trials published in scientific peer-reviewed journal publications were identified wherein low-level laser therapy (LLLT) was evaluated for its therapeutic ability to reduce post-operative pain following surgical procedures." The specific countries of origin for these studies are not mentioned, nor is whether they were retrospective or prospective.

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

• Not applicable for this submission. The ground truth for the efficacy of LLLT in reducing postoperative pain, if inferred from the cited literature review, would have been established by the authors, reviewers, and editors of the scientific journals in which those studies were published. No specific experts are mentioned as being involved in establishing a ground truth for a new test set in this 510(k).

4. Adjudication Method for the Test Set

• Not applicable for this submission, as no new clinical test set was used requiring adjudication.

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

• Not applicable. This device is a therapeutic laser, not an AI-assisted diagnostic or interpretive system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a therapeutic laser.

7. The Type of Ground Truth Used

• For the expanded indication, the "ground truth" is asserted based on outcomes data (reduction in postoperative pain) reported in seven randomized controlled clinical trials of low-level laser therapy (LLLT) published in scientific peer-reviewed journals. This is a general ground truth for the category of therapy, not a specific ground truth for the Erchonia® XLR8 in a new clinical study.

8. The Sample Size for the Training Set

• Not applicable for this submission. There is no mention of a training set as this is a medical device submission based on substantial equivalence and literature review, not a machine learning algorithm.

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

• Not applicable. (See #8).

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