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The Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia (Hair Loss) and to promote hair growth in Males who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV. The Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia (Hair Loss) and to promote hair growth in Females who have Ludwig (Savin) 1-4, 11-1, 11-2, or frontal patterns of hair loss and Fitzpatrick Skin Types I to IV.

The Sunetics Clinical Laser (model "G" & model "W2326") is a stationary, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in both Males and Females. The Sunetics Clinical Laser device provides distributed red laser light dispersing from an "Open Panel" Hood utilizing laser modules with a 650 nm wavelength, <5 mW output power, producing a continuous wave "CW" output beam. The "Open Panel" Hood is designed to maximize the delivery of the coherent laser light to effectively cover the entire scalp of the user during treatment.

The provided text describes the Sunetics Clinical Laser device and its 510(k) submission for market clearance. However, it does not contain information about a study that used a test set, ground truth established by experts, or statistical performance criteria for the device's efficacy in treating hair loss.

The document focuses on the device's technological characteristics, safety testing (electrical, EMC, laser classification), and its substantial equivalence to predicate devices based on these characteristics and intended use. Performance data is mentioned as confirming similar laser wavelength, output power, etc., but this refers to technical specifications, not clinical efficacy metrics.

Therefore, most of the requested information cannot be extracted from this document, as a clinical performance study as described in the prompt was not part of this 510(k) submission.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

2. Sample sized used for the test set and the data provenance:

• Not applicable / Not provided. The submission focuses on device safety and technical equivalence, not a clinical efficacy study with a test set of patients.

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

• Not applicable / Not provided. No clinical test set or ground truth on efficacy was established as part of this submission.

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

• Not applicable / Not provided. No clinical test set.

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:

• No. This document is for a laser therapy device, not an AI-assisted diagnostic tool requiring MRMC studies.

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

• Not applicable. This is a physical therapy device, not an algorithm.

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

• Not applicable / Not provided for clinical efficacy. The "performance data" mentioned relates to the device's technical specifications and electrical/laser safety, not clinical outcomes for hair growth. The ground truth for safety aspects would be compliance with international standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1).

8. The sample size for the training set:

• Not applicable / Not provided. This device does not have a "training set" in the context of machine learning or clinical trials.

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

• Not applicable / Not provided.

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The Sunetics LaserBrush is indicated to treat Androgenetic Alopecia, promote hair growth and prevent further hair loss in males who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV & also in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss & Fitzpatrick Skin Types I to IV.

The Sunetics LaserBrush consists of a handheld low-level laser device intended to promote hair growth. Depending upon the Sunetics LaserBrush model, the device provides distributed laser light using seven (7), nine (9), or twelve (12), collimated, 650 nm, <5 mW laser modules, while brush bristles simultaneously part the user's hair to ensure that the laser light reaches the user's scalp.

The provided 510(k) submission for the Sunetics LaserBrush does not include a study demonstrating device performance against specific acceptance criteria relevant to an AI/ML medical device. The submission focuses on substantial equivalence to a predicate device (HairMax LaserCombs) through comparison of technological characteristics.

Therefore, the following information is not present in the provided text:

• A table of acceptance criteria and reported device performance (in the context of AI/ML performance metrics).
• Sample size for the test set or data provenance for an AI/ML study.
• Number of experts or their qualifications for establishing ground truth for an AI/ML study.
• Adjudication method for an AI/ML study.
• Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done or its effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used for an AI/ML study.
• Sample size for the training set for an AI/ML model.
• How ground truth for the training set was established for an AI/ML model.

What is provided regarding performance:

The submission states under "Performance Data":
"The laser wavelength, average and peak power levels, laser treatment field and energy delivery of the Sunetics LaserBrush and the Lexington Hairmax LaserComb were substantially equivalent."

And in the "Conclusions":
"The performance data discussed above demonstrate that the Sunetics LaserBrush device is as safe and effective as the predicate device."

This indicates that the "performance data" refers to the physical and operational characteristics of the laser device being comparable to the predicate, rather than clinical efficacy data generated from a new trial or AI/ML performance metrics. The FDA's 510(k) clearance confirms substantial equivalence based on these comparisons.

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