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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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The SAPPHIRE is an over -the -counter hand held, battery operated, light therapy device that uses light emitting diodes (LEDs) that emit a specific wavelength of 415nm (Blue Light) that is intended for use in the treatment of mild to moderate inflammatory acne.

The Sapphire device is an over-the-counter, battery powered, hand-held device that emits light energy in the blue spectrum for the treatment of mild to moderate inflammatory acne by emitting 50 mW/cm² of blue (415 nm +/- 5nm) light via an electric light emitting diode [LEDs] energy source. The Sapphire device operates by a cordless system drawing upon its rechargeable Li-Ion batteries to deliver the treatment. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. There are no user settings or adjustments required. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).

The provided text describes the Sapphire device, an over-the-counter hand-held, battery-operated light therapy device that uses LEDs emitting 415nm (Blue Light) for treating mild to moderate inflammatory acne. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against acceptance criteria in a clinical study.

Here's a breakdown of the requested information based on the provided text:

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

The provided text does not explicitly state specific quantitative acceptance criteria or a direct comparison of the Sapphire device's performance against such criteria in a clinical efficacy study. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on shared technological characteristics and intended use. The "performance" described is in terms of safety and technical conformance.

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

• Sample Size for Usability/Label Comprehension Study: 35 participants.
• Data Provenance: The document does not specify the country of origin for the usability study. It is implied to be a prospective study as participants "were able to comprehend" and "were able to use," suggesting active participation during the study.
• For Efficacy: The document does not report a clinical efficacy study for the Sapphire device; instead, it relies on substantial equivalence to predicate devices. Therefore, there is no sample size for an efficacy test set.

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 as no clinical efficacy study with a ground truth established by experts is reported for the Sapphire device. The "test set" mentioned applies to the usability/label comprehension study, which doesn't involve medical experts establishing a "ground truth" in the clinical sense.

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

This information is not applicable as no clinical efficacy study requiring adjudication of findings is reported. The usability study would likely involve direct observation or survey responses, not an 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

This information is not applicable. The Sapphire device is a light therapy device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is irrelevant to this device.

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

This information is not applicable. The Sapphire device is a physical light therapy device, not a standalone algorithm.

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

This information is not applicable for a clinical efficacy study, as such a study is not reported. For the usability study, the "ground truth" would be the observed ability of participants to understand the labeling and operate the device successfully.

8. The sample size for the training set

This information is not applicable as no clinical efficacy study requiring a training set for an algorithm is reported for the Sapphire device.

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

This information is not applicable as no clinical efficacy study requiring a training set is reported.

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