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The Bosley Booster 128 Laser Cap, Boster 162 Laser Cap, and Bosley Booster 288 Laser Cap 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-2, or frontal; both with Fitzpatrick Skin Types I to IV.

The Bosley Booster Family of 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 photo-stimulation of visible, red laser diodes and LEDs at 650-nm and 5mW each. The lasers and diodes are contained inside a lightweight cap. The device is powered by an included battery pack and automatically turns off after 30 minutes. The Boster Family of Laser Caps are identical to the cleared Bosley Revitalizer 272, 164 and 96 Laser Caps with the exception of the number of included low level laser diodes (LDs) and LEDs as shown below:

1. Configuration of Models

The provided text is a 510(k) premarket notification for a medical device (Bosley Booster Laser Caps) and does not describe a study involving acceptance criteria and device performance in the context of an AI/ML algorithm.

Instead, the document focuses on demonstrating that the new devices are substantially equivalent to previously cleared predicate devices, primarily by comparing their technological characteristics and safety profiles. The key points are:

• No AI/ML Algorithm: The devices described are Low-Level Laser Therapy (LLLT) devices that use red light laser diodes and LEDs to stimulate hair growth. There is no mention of any AI or machine learning component in their design or function.
• Substantial Equivalence: The primary goal of this submission is to show that the Bosley Booster Laser Caps are substantially equivalent to existing cleared devices (Bosley Revitalizer Laser Caps and other reference devices). This means showing that the new devices are as safe and effective as the predicate devices, with no new questions of safety or effectiveness raised.
• Performance Data for Device Hardware: The "Performance Data" section refers to verification and validation activities conducted on the hardware (e.g., output of each laser diode, operation of safety interface, power pack output) to confirm compliance with design specifications and recognized standards (e.g., IEC-60601-1, IEC-60601-2-22).
• Risk Analysis (FMEA): A Failure Modes and Effects Analysis (FMEA) was used to identify and assess risks, concluding that the reduced number of laser diodes and LEDs in the new models does not introduce new unacceptable risks.
• No Clinical Efficacy Study Mentioned for This Submission: While the devices are indicated to promote hair growth, the document does not present a new clinical study to establish the efficacy of the Bosley Booster Laser Caps. Instead, it relies on the established efficacy of the predicate devices, arguing that the minor variations in laser/LED count will only affect the time required to achieve the same results, not the fundamental efficacy or safety. The slight variations in total "dose" (delivered energy over time) are noted.
• No Ground Truth for AI/ML: Since there's no AI/ML component, there's no discussion of ground truth, training sets, test sets, or expert adjudication in that context.

Therefore, I cannot provide the requested table and study information related to acceptance criteria for an AI/ML device, as the provided text pertains to a hardware device without AI/ML characteristics.

If you can provide a document that discusses an AI/ML device in the context of a clinical study for regulatory submission, I would be able to answer your request.

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