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The Hair Growth Comb (Model: SZ-23 ,SZ-23A,) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to 1-4, Il-1, Il-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

The Hair Growth Comb is (Model: SZ-23, SZ-23A) a comb-shaped device that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 650nm (±10nm) while the comb teeth simultaneously part the user's hair to ensure the light reaches the user's scalp. The device is designed as a handheld product, and it consists of the main unit, the charging dock and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.

This document is a 510(k) Summary for a medical device (Hair Growth Comb, Models SZ-23, SZ-23A). It provides information regarding the device's substantial equivalence to previously cleared predicate devices, primarily focusing on its technical characteristics and safety testing.

Crucially, this document states: "Clinical testing was not needed for this 510(k)." This means that the submission does not include a clinical study designed to prove the device meets specific performance criteria related to the effectiveness of promoting hair growth. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document in the context of device performance regarding its intended clinical effect.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical testing for safety and electrical/software compliance, not clinical efficacy.

However, I can provide information based on the other aspects of the document:

Based on the provided 510(k) Summary, the following information can be extracted:

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

As no clinical efficacy study was conducted for this 510(k), there are no clinical performance acceptance criteria and reported device performance related to hair growth in this document. The "acceptance criteria" mentioned are related to safety and functional compliance.

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

• Clinical Test Set: Not applicable. "Clinical testing was not needed for this 510(k)." The testing described is non-clinical (electrical safety, EMC, biocompatibility, software).
• Data Provenance for Non-Clinical Tests: Performed by the manufacturer (Shenzhen Nuon Medical Equipment Co., Ltd) or contracted labs, adhering to international standards. The document doesn't specify countries of origin for test data, but the manufacturer is based in China. This is a pre-market submission, so the testing would be conducted retrospectively to the submission date.

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

• Not applicable for clinical ground truth related to hair growth efficacy, as no clinical study was conducted.
• For non-clinical testing, the "ground truth" is established by compliance with international standards (e.g., ISO, IEC) and the expertise lies within the testing laboratories and their personnel. The document does not specify the number or qualifications of these experts.

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

• Not applicable for clinical efficacy. For non-clinical compliance testing, "adjudication" in the sense of expert consensus on ambiguous cases is not a relevant concept. Compliance is determined by meeting pre-defined test parameters outlined in the standards.

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 physical comb that emits LED light, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

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

7. The type of ground truth used:

• Clinical Ground Truth: Not applicable, as no clinical efficacy study was conducted for hair growth. The substantiation for efficacy relies on substantial equivalence to predicate devices which were presumably cleared based on prior clinical data or deemed effective through other means (historical data, published literature, etc.).
• Non-Clinical Ground Truth: Established by adherence to recognized international standards for electrical safety (IEC 60601 series, IEC 62471), battery safety (IEC 62133-2), biocompatibility (ISO 10993 series), and software validation (IEC 62304, FDA Guidance).

8. The sample size for the training set:

• Not applicable for clinical efficacy, as no clinical study was conducted. For non-clinical tests, "training set" is not a relevant concept.

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

• Not applicable.

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