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The HairMax LaserComb Advanced 7 is indicated to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I to IV.

The HairMax LaserComb Pro 12 is indicated to treat Androgenetic Alopecia and promote hair growth in females with who have Ludwig-Savin Scale 1-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I to IV.

Similar to the HairMax Lux 9 K110233, the modified HairMax Advanced 7 and Pro 12 consist of a hand-held low level laser device that emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp.

The provided text describes modifications to an existing device (HairMax Lux 9) and seeks substantial equivalence for the new devices (HairMax Advanced 7 and Pro 12). Therefore, it primarily focuses on comparing the new devices to the predicate rather than presenting a standalone study with acceptance criteria and performance metrics for the new devices based on a clinical trial.

However, based on the nonclinical testing section, we can infer that the acceptance criteria for the HairMax Advanced 7 and Pro 12 were primarily related to their compliance with design specifications and operational functionality, as they are considered substantially equivalent to the previously cleared HairMax Lux 9. The study proving this involved performance testing to confirm compliance to design specifications; all functions were verified to operate as designed.

Here's a breakdown of the information that can be extracted or reasonably inferred from the provided text, while also noting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not mentioned. The testing described is "nonclinical testing" related to design specifications and functionality, not a clinical trial on human subjects.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned. Given it's nonclinical testing, this information would likely refer to laboratory or manufacturing test data, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Adjudication Method: Not mentioned. This type of method is typically associated with expert review of clinical data, which is not described here for the "test set" in question (which refers to nonclinical performance).

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a low-level laser device for hair growth, not an AI-assisted diagnostic or imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This device is a hardware device (laser comb), not an algorithm or software. Its performance is inherent in its physical operation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: For the nonclinical testing described, the "ground truth" would be the design specifications and operational requirements of the device. The testing verified that the devices operated as designed and met these predefined technical criteria. The "ground truth" for the intended use (promoting hair growth) would have been established by studies on the predicate device (HairMax Lux 9), which is not detailed in this document.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that uses training sets.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device.

Summary of what the document indicates for the new devices:

The document primarily focuses on demonstrating that the HairMax Advanced 7 and Pro 12 are substantially equivalent to the predicate device, HairMax Lux 9 (cleared under K110233). This substantial equivalence is based on:

• Identical intended use and indications for use.
• Identical core technological characteristics (same laser modules, hair parting teeth, operating principle, basic design, physical properties, materials, laser power, wavelength, delivery method, instructions for use, audible timer).
• The only difference being the quantity of laser modules, with treatment time adjusted to compensate.
• Nonclinical testing confirmed the new devices complied with design specifications and operated as designed, and that these modifications did not alter device safety.

The explicit detailed acceptance criteria and a human-results clinical study are not provided for the new devices in this document, as the submission relies on the established safety and efficacy of the predicate device.

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