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The enlighten III laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

1064 nm:
The 1064 nm wavelength of the enlighten III laser system is indicated for:

• treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI)
• tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)

532 nm:
The 532 nm wavelength of the enlighten III laser system is indicated for:

• treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III
• tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III

670 nm:
The 670 nm wavelength of the enlighten III laser system is indicated for treatment of benign pigments with Fitzpatrick skin types I-III.

The enlighten III laser system is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce multiple laser wavelengths and pulse widths (1064 and 532 nm: 750 ps and 2 ns; 670 nm: 660 ps).

The laser, power supplies, and control electronics are housed inside a console equipped with a touchscreen control panel. The laser treatment parameters are selected using the control panel. Laser emission is activated by depressing a footswitch. An articulated arm with rotational mirror knuckles delivers the laser beam from a laser head inside the console to a handpiece. The handpiece is equipped with an optical zoom assembly that determines the spot size of the laser beam on the treatment surface. The beam of a low-power diode laser is also transmitted through the arm to provide an aiming beam.

Here's an analysis of the acceptance criteria and study proving the device's performance, based on the provided text:

Device: enlighten III Laser System
Indications for Use (670 nm wavelength): Treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with pre-defined numerical targets. Instead, the study aims to demonstrate safety and efficacy, implicitly establishing that a certain level of improvement and safety is acceptable for market clearance. Based on the study results, the implied acceptance criteria for efficacy appears to be achieving statistically significant lightening (>50% improvement) and high patient satisfaction for the treatment of benign pigmented lesions. Safety is assessed by the absence of serious adverse events and good tolerability.

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

The study was a prospective clinical study. The document does not specify the country of origin of the data, but it is a US FDA 510(k) submission, suggesting the study likely took place in the US or followed international standards acceptable to the FDA.

• Total Enrolled: 48 subjects with Fitzpatrick skin types I-III and benign pigmented lesions.
• Cohort 1: 25 subjects with 32 subject-treatment-areas. (For analysis, a dataset of 25 observations was created by randomly selecting one treatment area per subject, 100 times).
• Inter-cohort subjects: 3 additional subjects with 5 subject-treatment-areas.
• Cohort 2: 20 subjects with a single subject-treatment-area.
• Completed Study: 46 subjects.

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

• Number of Experts: Three independent dermatologists.
• Qualifications: "Independent dermatologists" – further specific qualifications (e.g., years of experience) are not provided in the document.

4. Adjudication Method for the Test Set

The adjudication method involved a "blinded assessment of improvement (clearing)" completed by the three independent dermatologists. The description provides details on consistency:

• For Cohort 1, reviewers were consistent (kappa of 0.874) and accurate (kappa of 0.833) in identifying baseline and post-treatment photographs. 78% of photographs were scored identically or within one grade difference.
• For Cohort 2, reviewers were consistent (kappa of 1.0) and accurate (kappa of 1.0). 95% of photographs were scored identically or within one grade difference.
• Overall (presumably for all data by the three reviewers), scores were an exact match in 16% of BPL photographs, and within one grade difference in 79% of photographs.

This indicates an expert consensus approach, implicitly averaging or considering the predominant score for analysis given the high consistency. It isn't a strict "2+1" or "3+1" where a specific number of agreements is required; rather, the agreement level itself is reported as favorable.

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

No, an MRMC comparative effectiveness study was not done. The study evaluated the standalone performance of the enlighten III laser system for lesion clearing and safety, not how human readers' performance improved with AI assistance.

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

This study is for a laser system (medical device), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" as it applies to AI/software is not relevant here. The laser system itself is the "device" being evaluated in its standalone clinical application.

7. The Type of Ground Truth Used

The ground truth for efficacy was established through expert consensus based on blinded review of standardized photographs. The experts assessed "improvement (clearing)" of benign pigmented lesions. Safety ground truth was based on reported pain levels and observed/recorded adverse events by investigators.

8. The Sample Size for the Training Set

This document describes a clinical study for a laser device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML. The clinical study itself serves as the primary evidence for safety and efficacy for the device. If the question implies a "training set" for the clinical practice of using the device, that is not specified in this regulatory document.

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

As stated above, there is no training set in the context of AI/ML for this device.

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