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The Fotona Skinlight Plus Nd: YAG system is indicated for the photocoagulation of benign vascular and pigmented lesions.

The Fotona Skinlight Plus system is based on the addition of a Nd: YAG accessory to a previously cleared Er: YAG system (K962902). Within the accessory sub-system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of flashlamps. After the cavity,a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in noncontact mode. The System is capable of emitting up to 2.0 Watts of light at 532 nm, with a minimal pulsewidth envelope of 100ms. The laser is intended to be used for the photocoagulation of benign vascular and pigmented lesions. The Nd: YAG accessory sub-system is designed with 3 major sub-systems: a) An optical fiber delivery system terminated in spot-size specific handpiece. b) An electronic power supply and interface circuitry. c) An optical chamber containing laser rod and laser cavity optics. No accessories are available for use with the accessory Nd: Y AG sub-system.

This document is a 510(k) premarket notification for the Fotona Skinlight Plus Nd:YAG Laser system. It aims to demonstrate substantial equivalence to a previously cleared device, the Laserscope Aura system (K951034), for the photocoagulation of benign vascular and pigmented lesions.

The document does not contain a detailed study with acceptance criteria and reported device performance in the way that would typically be presented for an AI/Software as a Medical Device (SaMD). Instead, it relies on demonstrating substantial equivalence to a predicate device, which is a common pathway for medical device clearance.

Therefore, many of the requested sections about explicit acceptance criteria, study details, sample sizes, expert ground truth, and comparative effectiveness (which are typically relevant for AI/SaMD) cannot be directly extracted from this submission.

Here's a breakdown based on the provided text, addressing what can be inferred and what is not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define explicit performance acceptance criteria in terms of sensitivity, specificity, accuracy, or similar metrics, nor does it present device performance data against such criteria. The "acceptance criteria" here is implicitly demonstrating substantial equivalence to a predicate device based on similar intended use, technological characteristics (wavelength, power, pulsewidth), and safety/effectiveness profile.

The summary states:

• Intended Use: "The Fotona Skinlight Plus Nd: YAG system is intended for the photocoagulation of benign vascular and pigmented lesions." (Same as predicate)
• Wavelength: 532nm (Same as predicate)
• Maximum Average Power: 10 Watts (Same as predicate)
• Pulsewidth: 0.1 - 1.0 seconds (envelope width), with continuous emission option (Similar to predicate)

The document concludes: "It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device." This statement serves as the "reported device performance" in the context of a substantial equivalence claim – meaning its performance is considered equivalent to a device already deemed safe and effective.

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

Not applicable. This submission does not describe a clinical study with a "test set" in the context of an AI/SaMD performance evaluation. Substantial equivalence claims often rely on engineering analysis, bench testing, and comparison of characteristics, rather than patient-level performance data against a ground truth.

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

Not applicable. There is no "test set" and no ground truth established by experts for performance evaluation as would be done for an AI/SaMD.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described.

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 is a medical device (laser system), not an AI/SaMD for diagnostic interpretation. There is no mention of "human readers" or "AI assistance."

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

Not applicable. This is a physical medical device (laser), not a standalone algorithm.

7. The Type of Ground Truth Used

Not applicable. No "ground truth" (e.g., pathology, outcomes data) as would be used in a diagnostic performance study is described or utilized in this substantial equivalence claim. The "ground truth" for supporting the claim is the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/Machine Learning device that requires a "training set."

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

Not applicable. (As above, no training set).

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