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Laser Hair Therapy is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.

The Laser Hair Therapy is a comb-shaped low level laser therapy (LLLT) device that emits laser light with the intention to promote hair growth. The device provides distributed laser to the scalp at 655+/-5nm while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp.

The Laser Hair Therapy is designed as handheld product, and it consists of the power supply (adaptor and USB cable) and the control unit (RECREO device), as well as it is powered by the built-in rechargeable lithium battery. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the 8 minutes treatment is completed.

The provided text is a 510(k) Summary for a medical device called "Laser Hair Therapy" (Model: Recreo 200). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance criteria through a clinical study with detailed statistical outcomes.

Therefore, the text does not contain the specific information required to complete all sections of your request. It primarily outlines the technical characteristics and safety testing performed to show equivalence.

However, I can extract the available information:

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

Based on the document, direct performance acceptance criteria (e.g., a specific percentage increase in hair count) are not stated for the subject device. Instead, the performance data provided focuses on safety and biological compatibility, asserting that these aspects are similar to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not detail a "test set" in the context of a clinical performance study with human subjects. The performance data presented are for regulatory compliance tests (biocompatibility, electrical safety, EMC). These tests typically involve material samples or device units, not human subjects in a clinical trial. Therefore, information on sample size, country of origin, or retrospective/prospective nature for a clinical test set is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The "ground truth" concept usually refers to clinical outcomes established by experts for a diagnostic or predictive device. This device is a therapeutic device, and the provided data focuses on safety and technical compliance standards.

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

This information is not applicable and not provided, as there is no described clinical "test set" and associated adjudication process.

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

An MRMC comparative effectiveness study is not mentioned in the document. This type of study is relevant for diagnostic devices that involve human interpretation assisted by AI. The Laser Hair Therapy device is a standalone therapeutic device, not an AI-assisted diagnostic tool.

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

The document describes the "Laser Hair Therapy" device as a standalone therapeutic device designed to promote hair growth. The performance data provided are for this device itself (e.g., its electrical safety, biocompatibility, laser class), rather than an algorithm. Therefore, yes, its standalone (device only) performance with respect to safety and technical specifications was evaluated. However, no standalone clinical efficacy study (e.g., showing a quantified increase in hair growth) is presented in this 510(k) summary, as it relies on substantial equivalence to predicates that previously established such efficacy.

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

For the technical and biocompatibility performance data, the "ground truth" is defined by the specific international standards (e.g., ISO 10993-5, IEC 60601-1). Passing these standards is considered the "ground truth" for compliance. For the device's efficacy in promoting hair growth, this 510(k) summary relies on the established efficacy of its predicate devices, for which the ground truth would have been clinical outcomes data (e.g., hair count measurements, photographic assessment, patient self-assessment) from their own clinical trials. This document does not present new clinical efficacy data for the subject device.

8. The sample size for the training set

The document does not describe a "training set" as it is not an AI/machine learning device requiring a dataset for model training.

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

Not applicable, as there is no training set mentioned for this device.

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