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The Nutra Stim Hair Laser Comb is indicated to treat androgenetic alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, LL-1, LL-2, or frontal and Fitzpatrick Skin Types L to IV.

The Nutra Stim Hair Laser Comb is 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 Nutra Stim Hair Laser Comb unit contains the power supply, internal NI-MH rechargeable battery and the control unit. The enclosure and laser lens are made of medical grade biocompatibility plastics via injection molding. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Stim Hair Laser Comb does not use any software.

The provided text describes the Nutra Stim Hair Laser Comb, a low-level laser device intended for promoting hair growth and treating androgenetic alopecia in specific female populations. However, the document does not contain a study that establishes acceptance criteria for device performance in terms of clinical efficacy (hair growth), nor does it provide performance data against such criteria.

The document focuses on demonstrating substantial equivalence to a predicate device (HairMax Pro 12 LaserComb, K112524) for regulatory clearance, rather than presenting a clinical trial for performance.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

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

This information is not present in the document. The document discusses regulatory and safety testing but does not provide clinical performance acceptance criteria (e.g., minimum percentage increase in hair count, or specific visual improvement scores) or reported device performance against such criteria.

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

• Sample Size (Clinical): Not applicable for clinical efficacy. The document mentions an "OTC Usability Study" with "80 participants." This study was focused on usability and consumer understanding, not clinical performance for hair growth.
• Data Provenance: Not specified for any clinical performance data, as none is presented. For the OTC Usability Study, the provenance is not mentioned.
• Study Type: The OTC Usability Study was likely prospective, as it involved attracting participants to test the device's labeling and operation.

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)

This information is not present. The usability study did not involve establishing ground truth for efficacy using experts.

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

This information is not present. No such adjudication method is mentioned, as there was no clinical performance data requiring expert adjudication.

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. The device is a physical laser comb, not an AI-assisted diagnostic or interpretation tool.

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

• Standalone Performance Study: No, the device is not an algorithm. What was done were non-clinical performance tests for electrical safety, EMC, and biocompatibility, as listed in Section 8. These are tests of the device's physical and electrical properties, not its clinical standalone efficacy for hair growth.

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

This information is not present for clinical efficacy. For the OTC Usability Study, the "ground truth" was whether participants could correctly self-select, understand labeling, assemble, and operate the device. This "ground truth" would have been established by observing participant actions and responses against predefined correct answers or procedures.

8. The sample size for the training set

This information is not present. The document does not describe the development of an algorithm or model that would require a training set.

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

This information is not applicable, as there is no mention of a training set or an algorithm being developed.

Summary of Device and Regulatory Context (based on the provided text):

• Device Name: Nutra Stim Hair Laser Comb Model NSL-6318
• Intended Use/Indications: Treats androgenetic alopecia and promotes hair growth in females with Ludwig (Savin) Scale I-4, LL-1, LL-2, or frontal, and Fitzpatrick Skin Types I to IV.
• Regulatory Class: Class II
• Product Code: OAP (Lamp, nonheating, for promotion of hair growth)
• Regulation Number: 21 CFR 890.5500
• Predicate Device: HairMax Pro 12 LaserComb (K112524)
• Basis for Clearance: Substantial Equivalence to the predicate device.
• Supportive Studies Mentioned:
  • OTC Usability Study: 80 participants, focused on self-selection, understanding labeling/manual, assembly, and operation. All four goals of this study were reportedly met. This study did not assess clinical efficacy.
  • Nonclinical Performance Data: Risk analysis, verification, and validation tests (specifics not detailed in the summary, but referenced as being in Section 10). Compliance with electrical safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11) and laser safety (IEC 60825-1) standards. Biocompatibility testing per ISO 10993.

In conclusion, the provided document is an FDA 510(k) clearance letter and its accompanying summary, which primarily establishes substantial equivalence for marketing purposes. It highlights compliance with safety and usability aspects but does not present a clinical study with acceptance criteria and performance data related to the device's efficacy in promoting hair growth. The efficacy is implicitly accepted based on the substantial equivalence to the predicate device, which would have had its own supporting data for clearance.

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The Nutra Stim Hair Laser Comb is indicated to treat androgenetic alopecia, promote hair growth and prevent further hair loss in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and Fitzpatrick Skin Types I to IV.

The Nutra Stim Hair Laser Comb is 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 Nutra Stim Hair Laser Comb unit contains the power supply, internal NI-MH rechargeable battery and the control unit. The enclosure and laser lens are made of medical grade biocompatibility plastics via injection molding. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Stim Hair Laser Comb does not use any software.

The provided text describes a 510(k) premarket notification for the Nutra Stim Hair Laser Comb. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for a new device's efficacy.

Therefore, many of your requested details, particularly those related to a clinical study establishing performance against specific acceptance criteria for a novel device, are not directly available in this document. The document primarily relies on the predicate device's established effectiveness and safety, and direct comparison of technological characteristics.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

This specific table, comparing acceptance criteria to performance, is not provided in the document. The document describes an "OTC Usability Study" and lists its goals, which could be interpreted as acceptance criteria for usability, but it does not present quantifiable performance metrics against those goals.

2. Sample Size for Test Set and Data Provenance

The document mentions an "OTC Usability Study" with:

• Sample Size: 80 participants
• Data Provenance: Not explicitly stated, but it's an "OTC Usability Study," implying it was conducted with potential end-users for over-the-counter use, likely within the US, where the FDA is regulating it. It is a prospective study as participants were actively recruited to test the device's usability.

3. Number of Experts and Qualifications for Ground Truth

• This information is not provided as the usability study did not involve establishing a medical ground truth in the way a diagnostic device study would. The "ground truth" for the usability study was whether participants could successfully interact with the device and understand its labeling.

4. Adjudication Method for Test Set

• This information is not provided. Given it's a usability study where success was measured against understanding and operating the device, a formal adjudication process as seen in clinical trials for diagnostic accuracy is unlikely to have been implemented or necessary.

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

• No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. The Nutra Stim Hair Laser Comb is a therapeutic device for hair growth, not a diagnostic one.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study (algorithm only) was not conducted. The device is a physical laser comb, not an AI algorithm. The document mentions "The Nutra Stim Hair Laser Comb does not use any software," further confirming the irrelevance of an algorithm-only study.

7. Type of Ground Truth Used

• For the "OTC Usability Study," the "ground truth" was essentially observational success/failure in performing tasks (self-selection, understanding instructions, operating the device) and participant feedback. It was not based on expert consensus, pathology, or outcomes data in a medical sense for efficacy.

8. Sample Size for Training Set

• This information is not applicable and therefore not provided. The Nutra Stim Hair Laser Comb is a hardware device for therapeutic use; it does not involve AI or machine learning algorithms that require a "training set."

9. How Ground Truth for Training Set Was Established

• This information is not applicable and therefore not provided for the same reasons as #8.

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