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The ND YAG Q-switch Laser Therapy Machine is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.

The ND YAG Q-switch Laser Therapy Machine is laser system which delivers laser at a wavelength 1064nm or 532nm.

There are 3 models included, FG 2010, FG 2010-B, FG 2010-C, the three models have same intended use, mechanism of action, principle and specification, only differences are the configurations.

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel acceptance criteria or comprehensive study results for a new AI/software system. Therefore, much of the requested information regarding AI-specific criteria, studies, and ground truth establishment is not applicable or available in this document.

However, I can extract the relevant information from the provided text as it pertains to the device's performance claims and the studies conducted to support its substantial equivalence.

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

The document does not explicitly state acceptance criteria in the typical sense for a new AI/software device. Instead, it compares the proposed device's specifications and performance to a predicate device to demonstrate "substantial equivalence" (SE). The "reported device performance" is essentially the detailed specifications of the proposed device as presented for comparison.

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

No clinical test set or data provenance is mentioned as this device is not an AI/software product requiring such a test set. This submission relies on non-clinical testing to demonstrate substantial equivalence to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth establishment by experts for a test set is described, as the device is not an AI/software product that requires diagnostic performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set adjudication method 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 device is a laser therapy machine, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. This device is a laser therapy machine, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The equivalence is based on technical specifications and safety standards rather than diagnostic ground truth.

8. The sample size for the training set

Not applicable. No training set is mentioned for this device.

9. How the ground truth for the training set was established

Not applicable. No training set or ground truth establishment for a training set is described.

Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):

The study primarily consisted of non-clinical tests to verify that the proposed device met design specifications and was substantially equivalent (SE) to the predicate device (Harmony XL Multiple Application Platform, K072564).

The tests conducted focused on:

• Compliance with International Standards:
  • IEC 60601-1:2012 (Medical Electrical Equipment - Basic Safety and Essential Performance)
  • IEC 60601-2-22:2007 (Medical Electrical Equipment - Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment)
  • IEC 60825-1:2007 (Safety of laser products - Equipment classification and requirements)
  • IEC 60601-1-2:2007 (Electromagnetic compatibility)
• Biocompatibility:
  • ISO 10993-5:2009 (Tests for Vitro cytotoxicity)
  • ISO 10993-10:2002/Amd. 1: 2006 (Test for irritation and delay-type hypersensitivity)
• Specific Device Performance Tests:
  • Performance Testing for Spot Size Accuracy.
  • Thermal Energy Distribution Test (to determine the difference for thermal energy distribution of proposed device with predicate device).

No clinical study was included in this submission. The approach relied on demonstrating that the proposed device performed "as safe, as effective, and performs as well as the legally marketed predicate device" based on direct technical and safety comparisons and adherence to established medical device standards.

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