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The BOSLEY Revitalizer 272 and 164 Laser Caps are indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-3, or frontal; both with Fitzpatrick Skin Types I to IV.

Device Description

The BOSLEY Revitalizer 272 and 164 Laser Caps are low level laser therapy (LLLT) devices designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272 or 164 visible red light-emitting diodes at 650-nm and 5mW each. The lasers are contained inside a lightweight cap. The device is powered by an included battery pack and automatically turns off after 30 minutes.

AI/ML Overview

The provided text describes a 510(k) submission for the BOSLEY Revitalizer 272 and 164 Laser Caps. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device were primarily related to OTC/Usability Testing and Biocompatibility.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
OTC/Usability Testing	80% success rate in self-selection, comprehension of labeling and instructions, and usability. This includes accurate self-categorization of (a) skin type (I-IV) and (b) hair loss pattern (Norwood-Hamilton IIa-V for males, Ludwig (Savin) I-1 to I-4, II-1, II-3, or frontal for females), to determine candidacy for treatment or contraindication.	95% overall of participants correctly judged themselves on hair loss candidacy. 100% of participants accurately categorized their skin type as suitable for treatment or not suitable when compared with physician ratings. 100% of women correctly identified their candidacy for treatment or incorrectly judged themselves unsuitable for treatment based on hair loss self-rating. 90% of men correctly identified their candidacy for treatment or incorrectly judged themselves unsuitable for treatment based on hair loss self-rating (3 males incorrectly identified themselves as treatment candidates).
Biocompatibility	- Material used in manufacturing must be non-cytotoxic. - Material must not be a sensitizer for skin contact.	- Cytotoxicity tests demonstrated that the material used in the manufacturing of the caps is non-cytotoxic. The caps met the requirements of ISO 10993-1:2009, ISO 14971:2007, and FDA General Program Memorandum #G95-1, for surface devices with limited contact (<24 hours) with the skin and was considered safe for use. - Skin sensitization tests demonstrated that the material used in the manufacturing of the caps were not considered a sensitizer.
Non-clinical Performance	- Compliance to design specifications for all functions. - Operation as designed. - Meeting all acceptance criteria in performance testing.	- All functions were verified to operate as designed. - The BOSLEY Revitalizer 272 and 164 Laser Caps met all acceptance criteria in the performance testing.
Laser Safety	Certification to laser system classification 3R (same as predicate devices).	- Testing to IEC 60825-1 certifies the laser system to classification 3R.
Electrical Safety & EMC	Compliance with IEC 60601-1:2012 3rd Edition, IEC 60601-1-2, and IEC 60601-1-11. Charger conforms to IEC 60950. Battery conforms to IEC 62133.	- The BOSLEY Revitalizer 272 and 164 Laser Caps were tested and comply with Electrical Safety and EMC testing, including the requirements of IEC 60601-1:2012 3rd Edition, IEC 60601-1-2, and IEC 60601-1-11. - The charger conforms to IEC 60950 and the battery to IEC 62133.

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

Sample Size for OTC/Usability Test Set: 30 female participants and 30 male participants (total of 60). One male was excluded, making the total male population in the analysis 29. So, the effective sample size for analysis was 59 (30 females, 29 males).
Data Provenance: The study was conducted in February 2018. The specific country of origin is not explicitly stated, but the submission is to the U.S. FDA, and a US address is provided for the "Premarket Submission Applicant Name/510k Holder." The nature of the study (observing participant comprehension and usability in a controlled setting) makes it a prospective study.

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

Number of Experts: One licensed physician.
Qualifications of Experts: The expert was described as a "licensed physician skilled in hair loss and skin clinical studies."

4. Adjudication method for the test set

The text describes a process where participants self-evaluated their candidacy, and then a licensed physician rated their pictures for hair loss and skin type (ground truth). An independent blinded statistician was provided with this data. The "adjudication" in this context involved comparing the participant's self-assessment against the physician's assessment of hair loss and skin type. There wasn't an explicit 2+1 or 3+1 expert consensus method described for establishing the ground truth; rather, it was a single expert's assessment used as the reference.

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, an MRMC comparative effectiveness study was not done. This submission is for a Low-Level Laser Therapy (LLLT) device for hair growth, not an AI-assisted diagnostic or imaging device used by human readers. The study described focuses on usability and comprehension for over-the-counter use.

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

N/A. The device is a physical laser cap used by individuals, not a standalone algorithm. The "standalone performance" mentioned in the non-clinical testing section refers to the device's technical specifications and safety compliance (laser classification, electrical safety), not an AI algorithm's performance.

7. The type of ground truth used

For the OTC/Usability study, the ground truth for participant candidacy (hair loss classification and skin type) was established by a licensed physician skilled in hair loss and skin clinical studies reviewing photos of the participants.

8. The sample size for the training set

The document does not mention a training set or any machine learning/AI components. The non-clinical performance and usability studies described are for traditional medical device verification and validation.

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

N/A, as no training set for an AI/ML model was described.

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