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510(k) Data Aggregation
Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with recognized safety standards (e.g., IEC-60601-1) | Conforms to IEC-60601-1, IEC-60601-11, IEC-60601-2-22 (2007/Third Ed.), and IEC60825-1 (Ed. 3). Charger conforms to IEC 61959. |
| Laser class of 3R, AEL max 5 mW per diode | Laser class 3R, individual diode output ≤ 5mW. |
| Laser wavelength, output power (per diode), output beam, energy type, laser field, treatment area remain the same as predicate. | Exactly the same laser wavelength (650 nm), output power (per diode), output beam, energy type, laser field, and treatment area as the Bosley Revitalizer 272 and 164 Laser Caps. |
| No new unacceptable risks due to reduced number of laser diodes | Risk analysis (FMEA) concluded no new unacceptable risk due to reduced number of laser diodes. |
| Functionality operates as designed | All functions of the modified product have been verified to operate as designed, and all acceptance criteria (for functional verification) were met. |
| Acceptable efficacy given reduced dose | "Modestly lower efficacy is accepted by users, with the understanding that treatment is intended to be continued indefinitely." Believed that reduced number of laser diodes will only affect the time required to witness the same result. |
| No reported adverse events | No reported adverse events for these products (Bosley Revitalizer 272 and 164 Laser Caps, and reference devices). |
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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