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The Capillus laser domes 82, 202, 272 Pro, 272 OfficePro, 302, 312, and 352, are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to 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; both with Fitzpatrick Skin Types I to IV.

The Capillus272 Pro and Capillus272 OfficePro both consist of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner, and configured for portable use with rechargeable battery and adapter (Capillus272 Pro) and salon/spa use (Capillus272 OfficePro). The Capillus82, Capillus202, Capillus302, Capillus312, and Capillus352 are exactly the same as the Capillus272 Pro with the exception of the number of diodes which are respective of model (e.g. 82 diodes in Capillus82).

As stated in prior submissions, the devices emit an audible tone at the beginning and end of a therapy session, indicating that therapy has begun (2 short beeps) or ended (one long beep). The portable systems are powered by rechargeable Li-Ion battery cells assembled into a proprietary battery pack. Both the battery are fully compliant to recognized, international standards. The OfficePro is directly powered by the DC charger, which is fully compliant to recognized, international standards.

The provided document describes the acceptance criteria and the study conducted for the Capillus laser domes (Capillus 82, 202, 272 Pro, 272 Office Pro, 302, 312, and 352) to support their clearance for Over-the-Counter (OTC) sale.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 55 adult subjects.
• Data Provenance: Not explicitly stated regarding country of origin, but it describes a study designed to assess "real-world capability of the average adult, 'retail customer'". The study appears to be prospective, designed specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth:

• Not Applicable. The study described is a usability test for OTC sales, not a clinical efficacy study requiring expert-established ground truth for a medical condition. The criteria evaluated were self-selection and user instruction comprehension.

4. Adjudication Method for the Test Set:

• Not Applicable. As this was a usability test on self-selection and comprehension, not a diagnostic or efficacy study, an adjudication method in the traditional sense (e.g., for medical image interpretation) was not used. The pass rates were objectively determined based on subjects' responses to the test components.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC comparative effectiveness study was not done. The study conducted was a usability test for OTC use, not an effectiveness study comparing human readers with and without AI assistance for a diagnostic task.

6. Standalone (Algorithm Only) Performance Study:

• No. This device is hardware-based (laser domes) for hair growth and does not involve an "algorithm only" component in the sense of AI or software for diagnosis or analysis. The performance data presented refers to the device's physical and user-interface compliance.

7. Type of Ground Truth Used:

• For the usability study, the "ground truth" was established by pre-defined correct responses for self-selection (interpreting box labeling) and user instruction comprehension. This is based on pre-established criteria for user understanding and compliance, not a medical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set:

• Not Applicable. There is no mention of a "training set" as this is not an AI or machine learning algorithm requiring training. The document describes a usability study testing the device's instructions and labeling.

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

• Not Applicable. As no training set for an algorithm was used, this question is not relevant.

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The Capillus272 Pro is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of I-IV

The Capillus272Pro consists of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner. The use of this specific number of diode lasers 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. This is achieved by a safety interlock. At the beginning and end of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by rechargeable Nickel Metal Hydride battery cells assembled into a proprietary battery pack. Both the battery cells, pack and charger are fully compliant to recognized, international standards.

The Capillus 272 Pro is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of I-IV.

Here's an analysis of the provided information regarding the Capillus 272 Pro, organized according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds (e.g., a certain percentage increase in hair count for FDA clearance). Instead, the performance is reported as an "effectiveness" measure relative to a placebo.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated as a single number, but there were subjects in both the Capillus 272 Pro (active) group and the placebo group.
• Data Provenance:
  • Country of Origin: United States (multi-center, two sites).
  • Retrospective or Prospective: Prospective.

3. Number of Experts for Ground Truth and Qualifications

This information is not provided in the document. The study describes a "placebo-controlled, prospective trial" but does not detail how the ground truth for hair growth was assessed (e.g., by experts, automated systems, etc.).

4. Adjudication Method

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided in the document. The study was a comparison of the device to a placebo, not an assessment of human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

The device described is a physical light therapy device, not an algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and not mentioned.

7. Type of Ground Truth Used

The document implies that the ground truth for "hair growth" was established by measurements of terminal hair counts and observations of "positive results" for an increase in these counts. However, the exact methods for these measurements (e.g., photographic assessment, dermatoscopic analysis, direct counting) and who performed them are not detailed.

8. Sample Size for the Training Set

This information is not provided in the document. The study described is a clinical trial to evaluate the device's efficacy, not a study to train a new algorithm. "Training set" is typically relevant for AI/machine learning models.

9. How Ground Truth for Training Set Was Established

This information is not provided and is not applicable as there is no mention of a training set for an algorithm in this context.

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