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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)
• treatment of acne scars on patients with Fitzpatrick skin types II-V when used with the Micro Lens Array handpiece attachment

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-IV
• 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 pigmented lesions on patients with Fitzpatrick skin types I-III
• tattoo removal for lighter colored tattoo inks, including green and blue inks, on patients with Fitzpatrick skin types II-IV

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 and 2 ns).

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, as well as an optional Micro Lens Array handpiece attachment, which can be attached to the distal end of the handpiece to fractionate the treatment beam. The beam of a low-power blue diode laser is also transmitted through the arm to provide an aiming beam.

This document describes the Cutera enlighten III Laser System and its expanded indications for use, specifically for the treatment of acne scars with the Micro Lens Array handpiece attachment.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 33 subjects
• Data Provenance: The study was a prospective, multicenter, pivotal study. The country of origin of the data is not explicitly stated, but as the submission is to the U.S. FDA, it is generally assumed to be from the U.S. or international sites adhering to similar regulatory standards.

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

• Number of Experts: Three blinded dermatologist evaluators.
• Qualifications of Experts: They were identified as "dermatologist evaluators," implying they are medical doctors specializing in dermatology. No specific details on their years of experience are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: "at least two of three blinded dermatologist evaluators." This indicates a 2/3 consensus or majority rule for assessing improvement.

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

• A MRMC comparative effectiveness study was not directly reported in terms of comparing human readers with and without AI assistance. The study described is a clinical trial assessing the device's efficacy and safety for treating acne scars; it is not focused on an AI component for diagnosis or evaluation by human readers.

6. Standalone (Algorithm Only) Performance Study

• A standalone algorithm-only performance study was not applicable/not performed as this device is a laser system for treatment, not an AI diagnostic or assistive algorithm.

7. Type of Ground Truth Used

• The ground truth for the efficacy endpoint (improvement in acne scars) was established by expert consensus (at least two of three blinded dermatologist evaluators) based on the visual assessment of randomized baseline and follow-up images.
• Patient satisfaction and willingness to undergo treatment again serve as a form of patient-reported outcomes data.

8. Sample Size for the Training Set

• The document describes a clinical study for the validation of the device's efficacy and safety for a new indication. It does not mention a "training set" in the context of an algorithm. The 33 subjects are part of the evaluative study, not a training set for an AI model.

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

• Not applicable, as there is no mention of a "training set" for an algorithm in this submission. The 33 subjects were part of the prospective clinical study to assess the device's performance for the expanded indication.

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