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The Aduro Comb (Model: SZ-22A) 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 I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

Device Description

The Aduro Comb is (Model: SZ-22A) 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 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.

AI/ML Overview

The Aduro Comb (Model: SZ-22A) is indicated to treat Androgenetic Alopecia and promote hair growth. The following information outlines its acceptance criteria and the studies performed.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance	Reported Performance
Electrical Safety	Compliance with AAMI/ANSI ES60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-1-2	Complies with all listed standards
Photobiological Safety	Compliance with IEC 62471	Complies with IEC 62471
Battery Safety	Compliance with IEC 62133-2	Complies with IEC 62133-2
Biocompatibility (for patient-contacting materials)	Compliance with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-10 (Irritation)	Complies with all listed ISO 10993 standards, based on equivalence to previously cleared devices.
Software Verification and Validation	Compliance with IEC 62304 and FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"	Documentation provided and considered sufficient for a "moderate" level concern software.

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

The document explicitly states, "Clinical testing was not needed for this 510(k)." Therefore, there was no clinical test set in the traditional sense, and thus no sample size or data provenance from a clinical study for the device's efficacy. The performance evaluation relied solely on non-clinical testing and comparison 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, as no clinical test set was used to assess the device's efficacy or establish ground truth from experts. The evaluation focused on non-clinical safety and performance.

4. Adjudication method for the test set

Not applicable, as no clinical test set was used.

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 an infrared lamp for hair growth, not an AI-assisted diagnostic or imaging device that would typically involve human readers.

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

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

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was compliance with established international and national standards for electrical safety, photobiological safety, battery safety, and biocompatibility.

8. The sample size for the training set

Not applicable, as this device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as there was no training set.

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