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The HIGHERDOSE Red Light Hat is a home wearable light-emitting diode phototherapy device with proven wavelengths of light 650nm±10nm Red light, which are used to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classfications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to 1-4, 11-1, 11-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types 1 - 1V.

The HIGHERDOSE Red Light Hat is a home wearable light-emitting diode phototherapy device with proven wavelengths of light 650nm±10nm Red light, which are used to treat Androgenetic Alopecia and promote hair growth in males who have Nowood- 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.

The device is designed as wearable product, and it consists of the main unit, the controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery.

The hat compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of cotton.

The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The HIGHERDOSE Red Light Hat cannot be operated while charging. The controller switches the LEDs ON/OFF. Switch the controller ON and allow the hat to run for 10 minutes treatment program. The cable for connecting with the controller is detachable.

The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

The provided text describes a 510(k) submission for the HIGHERDOSE Red Light Hat (HG-120K), seeking substantial equivalence to predicate devices for treating Androgenetic Alopecia and promoting hair growth.

However, the documentation does not contain information regarding a clinical study with acceptance criteria and reported device performance related to hair growth outcomes. Instead, it focuses on non-clinical performance testing (electrical safety, EMC, usability, software verification, and biocompatibility) to demonstrate safety and effectiveness for a device marketed as an Over-The-Counter Infrared Lamp.

The document explicitly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively." This means that the FDA's clearance for this device was based on a comparison to predicate devices and engineering/safety tests, not on new clinical data demonstrating its efficacy in hair growth.

Therefore, it is not possible to extract the requested information from the provided text regarding:

1. A table of acceptance criteria and reported device performance for hair growth.
2. Sample size and data provenance for a test set proving hair growth efficacy.
3. Number and qualifications of experts for ground truth establishment for hair growth.
4. Adjudication method for a hair growth test set.
5. MRMC comparative effectiveness study for human readers with and without AI assistance for hair growth.
6. Standalone performance of an algorithm without human-in-the-loop for hair growth.
7. Type of ground truth used for a hair growth study.
8. Sample size for a training set (as no AI algorithm for diagnosis/prognosis is implied).
9. How ground truth for a training set was established.

The document primarily addresses the substantial equivalence requirements by comparing the technical specifications and intended use of the HIGHERDOSE Red Light Hat with previously cleared infrared lamp devices, and by demonstrating compliance with relevant electrical and safety standards.

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