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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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NutraStim Hair Laser Helmet is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.

NutraStim Hair Laser Helmet is a low-level laser device and is intended/indicated for over- the -counter use. The device emits laser light with the intention to promote hair growth. The device provides timed treatments of distributed laser light to 100% of the scalp at 650 +/- 5 nanometers. The lasers are configured inside a helmet, designed for hands-free operation during treatment. The helmet is for portable use with rechargeable battery and adapter.

The provided document describes the NutraStim Hair Laser Helmet, a low-level laser device intended to treat Androgenetic Alopecia and promote hair growth. The device is being submitted for 510(k) clearance, asserting substantial equivalence to legally marketed predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of pass/fail metrics with specified thresholds for clinical efficacy. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and safety standards.

However, we can infer some key performance and safety characteristics against which the device was evaluated, and its reported performance:

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

The document mentions a "lay-user study and self-selection study" but does not specify the sample size used for this test set.

The data provenance is not explicitly stated in terms of country of origin. The study was conducted with "Institutional Review Board (IRB) approval and oversight," which typically implies prospective data collection, but this is not explicitly confirmed as "prospective" or "retrospective" in the text. Given the nature of a "lay-user study and self-selection study" for device usability, it's highly probable it was a prospective study where participants interacted with the device and its instructions in a controlled setting.

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

For the lay-user and self-selection study, the concept of "ground truth" as it relates to expert medical diagnosis or outcome (e.g., hair growth assessment by radiologists) is not applicable here. The "ground truth" for this usability study would be the observable ability of lay users to correctly understand instructions and self-select.

There is no mention of experts being used to establish a medical or diagnostic ground truth for the device's efficacy. The study focused on usability and understanding of instructions.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the lay-user and self-selection study. Adjudication, such as 2+1 or 3+1, is typically used for ambiguous or complex diagnostic assessments, which is not the nature of this usability study. The determination of whether a user "successfully follow[ed] the instructions" or "properly self-select[ed] themselves" likely came from direct observation and analysis of their actions and responses during the study.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a direct-to-consumer medical device (infrared lamp/laser for hair growth) and does not involve human readers interpreting images or data, nor does it involve AI assistance in the way a diagnostic AI would. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not relevant here.

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

The device is a physical laser helmet and does not involve an algorithm or AI in the traditional sense. Its performance is inherent in its physical parameters (wavelength, power, treatment protocol) and its interaction with the human scalp. Therefore, a "standalone algorithm-only" performance study is not applicable. The "standalone" performance would be its direct physical output characteristics, which were tested against engineering standards (e.g., IEC 60825-1 for laser classification, output per diode).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the lay-user and self-selection study, the ground truth was based on the observable actions and stated understanding of the lay users regarding the product labeling and user manual. It's an assessment of user comprehension and usability, rather than a clinical ground truth for hair growth outcomes.

The broader "performance data" supporting substantial equivalence relies on:

• Engineering and Safety Standards Compliance: Confirmed by testing to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60825-1, and ISO 14971.
• Comparison to Predicate Device Specifications: Wavelength, output, laser classification, number of diodes, treatment protocol, etc., are directly compared to those of legally marketed predicate devices, implying that the established performance and safety profiles of these predicates serve as a de facto "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

This document describes a premarket notification for a medical device that does not use machine learning or AI algorithms in its core functionality. Therefore, the concept of a "training set" for an algorithm is not applicable. The data presented supports its safety and technological equivalence, not the training of an AI model.

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

As there is no training set for an AI algorithm, this question is not applicable.

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