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The Bosley Revitalizer 96 Laser Cap is 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-2, or frontal; both with Fitzpatrick Skin Types I to IV.

The Bosley Revitalizer 96 Laser Cap consists of 96 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable use with rechargeable battery and adapter. Just as with the Bosley Revitalizer 272 and 164 Laser Caps, the 96 Laser Cap system can detect whether or not the device is in the correct position on the user's head and will automatically pause therapy if it is not. The device will resume therapy when the correct head position is re-established. The system is powered by rechargeable Lithium-ion battery cells assembled into a proprietary battery pack. Both the battery pack and charger are fully compliant with recognized, international standards.

The provided text is a 510(k) Premarket Notification summary for the Bosley Revitalizer 96 Laser Cap. Based on the document, this is a Special 510(k) submission, meaning the device is a modification of a previously cleared device. Therefore, a new, independent clinical study to prove efficacy and safety against new acceptance criteria was not performed. Instead, the submission relies on the substantial equivalence to predicate devices and verification/validation activities to confirm that the modifications do not introduce new risks or significantly alter performance compared to the original design.

Here's an analysis of the requested information based on the provided text:

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

The document doesn't explicitly state numerical acceptance criteria for a new clinical study. Instead, it relies on the safety and efficacy of its predicate devices. The "performance" assessment is primarily focused on confirming that the modified device (with fewer diodes) still meets established safety standards and that its reduced "dose" is acceptable given the intended indefinite use and lower cost.

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

No new clinical study was conducted for this Special 510(k) submission. The performance assessment relied on verification and validation activities of the modified device and comparison to previously cleared predicate devices. Therefore, there is no "test set" in the context of a new clinical efficacy study, nor explicit sample size or data provenance from such a study.

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)

Not applicable, as no new clinical study requiring ground truth establishment was conducted for this Special 510(k) submission.

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

Not applicable, as no new clinical study requiring adjudication was conducted for this Special 510(k) submission.

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. The device is a laser cap for hair growth, not an AI-assisted diagnostic tool involving human readers.

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

Not applicable. The device is a hardware device for hair growth, not an algorithm.

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

Not applicable, as no new clinical study requiring ground truth was conducted for this Special 510(k) submission. The efficacy claims for the predicate devices would have been based on clinical trials measuring hair growth (e.g., hair count, global photographic assessment), but details of those specific ground truths are not provided in this document.

8. The sample size for the training set

Not applicable, as no new clinical study was conducted. No "training set" in the context of AI or a new clinical trial is mentioned.

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

Not applicable, as no new clinical study was conducted.

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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.

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.

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.

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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The Capillus laser domes 82, 202, 272 Pro, 272 OfficePro, 302, 312, and 352, are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to 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; both with Fitzpatrick Skin Types I to IV.

The Capillus272 Pro and Capillus272 OfficePro both consist of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner, and configured for portable use with rechargeable battery and adapter (Capillus272 Pro) and salon/spa use (Capillus272 OfficePro). The Capillus82, Capillus202, Capillus302, Capillus312, and Capillus352 are exactly the same as the Capillus272 Pro with the exception of the number of diodes which are respective of model (e.g. 82 diodes in Capillus82).

As stated in prior submissions, the devices emit an audible tone at the beginning and end of a therapy session, indicating that therapy has begun (2 short beeps) or ended (one long beep). The portable systems are powered by rechargeable Li-Ion battery cells assembled into a proprietary battery pack. Both the battery are fully compliant to recognized, international standards. The OfficePro is directly powered by the DC charger, which is fully compliant to recognized, international standards.

The provided document describes the acceptance criteria and the study conducted for the Capillus laser domes (Capillus 82, 202, 272 Pro, 272 Office Pro, 302, 312, and 352) to support their clearance for Over-the-Counter (OTC) sale.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 55 adult subjects.
• Data Provenance: Not explicitly stated regarding country of origin, but it describes a study designed to assess "real-world capability of the average adult, 'retail customer'". The study appears to be prospective, designed specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth:

• Not Applicable. The study described is a usability test for OTC sales, not a clinical efficacy study requiring expert-established ground truth for a medical condition. The criteria evaluated were self-selection and user instruction comprehension.

4. Adjudication Method for the Test Set:

• Not Applicable. As this was a usability test on self-selection and comprehension, not a diagnostic or efficacy study, an adjudication method in the traditional sense (e.g., for medical image interpretation) was not used. The pass rates were objectively determined based on subjects' responses to the test components.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC comparative effectiveness study was not done. The study conducted was a usability test for OTC use, not an effectiveness study comparing human readers with and without AI assistance for a diagnostic task.

6. Standalone (Algorithm Only) Performance Study:

• No. This device is hardware-based (laser domes) for hair growth and does not involve an "algorithm only" component in the sense of AI or software for diagnosis or analysis. The performance data presented refers to the device's physical and user-interface compliance.

7. Type of Ground Truth Used:

• For the usability study, the "ground truth" was established by pre-defined correct responses for self-selection (interpreting box labeling) and user instruction comprehension. This is based on pre-established criteria for user understanding and compliance, not a medical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set:

• Not Applicable. There is no mention of a "training set" as this is not an AI or machine learning algorithm requiring training. The document describes a usability study testing the device's instructions and labeling.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As no training set for an algorithm was used, this question is not relevant.

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