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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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The Capillus82 is indicated to promote hair growth in females who have androgenic alopecia and Ludwig-Savin Classifications of I- II; and with Fitzpatrick Classification of Skin Phototypes I to IV.

The Capillus82 consists of 82 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable use with rechargeable battery and adapter.

The provided document is a 510(k) summary for the Capillus 82 device, which is indicated for promoting hair growth in females with androgenic alopecia. This document asserts substantial equivalence to a predicate device (Capillus 272 Pro) and other reference devices, rather than presenting a new study for the Capillus 82 that establishes its own acceptance criteria and performance against those criteria.

Therefore, the following information is not directly available from the provided text for the Capillus 82:

• A new table of acceptance criteria and reported device performance from a new study for the Capillus 82. Instead, the document argues that the Capillus 82 meets the same safety and efficacy profiles as its predicate device due to similar technology and reduced "dose."
• Sample sizes used for testing.
• Data provenance, number of experts, qualifications of experts, or adjudication methods for establishing ground truth from a new study.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results from a standalone algorithm-only performance study (as this is a physical device, not an AI algorithm).
• Details on the sample size for the training set or how ground truth was established for a training set (again, not an AI algorithm context).

However, the document does provide information that relates to performance and criteria through its comparison to predicate devices and adherence to existing standards. I can extract this information and present it in a way that addresses your request where possible, clarifying when the information refers to the predicate device or general standards rather than a new study for the Capillus 82.

Here's a breakdown of the available information based on your requested categories:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" and "reported device performance" for a new study of the Capillus 82 itself. Instead, it claims substantial equivalence based on the technological characteristics and conformity to standards. The closest representation of "performance" relates to its intended use and efficacy, which is inferred to be similar to predicate devices, albeit with potentially slower results due to fewer diodes.

Study Proving Acceptance Criteria:

The document describes the Capillus 82 as a modification of the previously cleared Capillus 272 Pro (K143199). The "study" for the Capillus 82 is primarily focused on design control activities, verification, and validation to demonstrate that the reduction in the number of lasers does not introduce new safety concerns and that the device still performs its intended function, albeit potentially with slower efficacy.

The key points regarding how the device meets acceptance criteria are:

• Substantial Equivalence Argument: The core of the submission is the claim that Capillus 82 is substantially equivalent to predicate devices (Capillus 272 Pro, Theradome Laser Helmet, MEP-90) and reference devices (Hairmax Lasercomb). This implies that if the predicate devices met their acceptance criteria, and the Capillus 82 is sufficiently similar, it also meets criteria.
• Design Control Activities (21 CFR 820.30): The manufacturer followed design control procedures. This involved:
  • Risk Assessment: Identified and assessed risks of reducing diodes; found no significant changes or risks for the Capillus 82 compared to the Capillus 272 Pro.
  • Verification: Activities were performed to assess the impact of the change (reduction of laser diodes). Laser diode output remained the same, but dosage was reduced.
  • Validation: Feedback from specialists and consumers indicated acceptance of a lower-cost alternative with potentially slower efficacy, understanding that treatment is indefinite.
• Conformity to Standards:
  • IEC-60825-2007-03: The device conforms to this standard for laser safety, establishing it as a Class 3R laser with an AEL of 5mW maximum.
  • IEC 61959: The charger conforms to this standard.

The document explicitly states: "Performance testing was conducted to confirm compliance to design specifications; all functions have been verified to operate as designed. All acceptance criterion were met by the device." (Page 6)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a new clinical "test set" for the Capillus 82. The verification and validation activities are primarily engineering and risk-based, comparing the modified device to the established performance of the predicate. Data provenance for the original predicate device's studies is not detailed in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a diagnostic device or an AI algorithm requiring expert ground truth for a test set in the traditional sense. "Ground truth" for efficacy of this type of device is typically established through clinical trials (which would have been done for the predicate devices). "Feedback from hair restoration specialists and consumers" was used for design validation (page 5), but details on the number or qualifications are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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

Not applicable. This is a physical device, not an AI system.

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

Not applicable. This is a physical device.

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

The "ground truth" for the efficacy claim (promoting hair growth) of this technology (Low-Level Laser Therapy) would have been established through clinical trials for the predicate devices and other similar devices, likely using outcomes data such as hair count measurements and photographic assessments. For the Capillus 82 itself, the ground truth is essentially the established performance and safety profile of the predicate device, against which the modifications are evaluated for substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established

Not applicable. This is not an AI algorithm.

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