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The igrow-II Hair Growth System is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and Fitzpatrick Classification of Skin Phototypes of I-IV

The Igrow-II Hair Growth System consists of 21 red visible light, diode lasers and 30 red light super-luminescent diodes configured within an outer helmet and protective inner. The use of diode lasers and non-laser LEDs provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.

The provided document is a 510(k) premarket notification for the igrow-II Hair Growth System. It describes the device, its intended use, and performance data related to its classification as an Over-The-Counter (OTC) device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 30 male subjects.
• Data Provenance: The document does not specify the country of origin. The study appears to be prospective, designed to assess the real-world capability of average male retail customers.

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

The study described refers to "comprehension of user instructions and warnings and precautions" for OTC use, not a clinical efficacy study with ground truth established by medical experts for hair growth. The ground truth here is the successful comprehension of the device's usage instructions by the test subjects. The document does not detail how this "successful comprehension" was measured or adjudicated beyond stating an 83.33% pass rate. No medical experts (e.g., dermatologists or radiologists) were involved in establishing this specific "ground truth."

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The "pass rate" of 83.33% implies a direct assessment of each subject's comprehension against a predefined set of criteria, but the method of determining a "pass" or "fail" for each subject is not detailed.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a "Hair Growth System" (an infrared lamp), not an AI-powered diagnostic or assistive tool. The study described focuses on user comprehension for OTC classification, not a comparative effectiveness study involving human readers or AI.

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

This question is not applicable. The device is a physical infrared lamp system, not an algorithm. The "performance data" refers to user comprehension of its operation for OTC classification, not an algorithm's performance.

7. The Type of Ground Truth Used

The "ground truth" for the performance data presented is the successful comprehension by test subjects of user instructions, warnings, and precautions related to the device's operation. This is in the context of obtaining an Over-The-Counter (OTC) classification, indicating the device can be used safely and effectively by consumers without professional medical guidance.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or algorithm development. The 30 male subjects were part of the testing for OTC comprehension.

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

This question is not applicable, as there is no mention of a training set or associated ground truth establishment for an algorithm within the provided text. The study described is a human factors/usability assessment for OTC classification.

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