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The family of DermaScalp Laser Cap devices are indicated to treat Androgenetic Alpopecia and promote hair growth in Males who have Norwood Hamilton Classifications of IIa 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-2, or frontal; both with Fitzpatrick Skin Types I to IV.

The family of DermaScalp Laser Cap devices are a hands-free, portable, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Males and Females. The DermaScalp Laser Cap devices provide distributed red laser light dispersing from a "Concave" scalp covering utilizing laser modules with a 650 nm wavelength, <5 mW output power, producing a continuous wave "CW" output beam. The "Concave" scalp covering is designed to maximize the delivery of the coherent laser light to effectively cover the entire scalp of the user during treatment.

This document, a 510(k) Summary for the DermaScalp Laser Cap, describes performance data and criteria primarily in the context of demonstrating substantial equivalence to predicate devices, rather than a standalone evaluation against specific, quantitative acceptance criteria for its effectiveness in treating androgenetic alopecia and promoting hair growth.

The document focuses on comparing the DermaScalp Laser Cap's design, intended use, and general performance with existing FDA-cleared devices (predicates) to argue for substantial equivalence. It does not present a detailed study proving the device meets quantitative acceptance criteria for clinical efficacy through a direct clinical trial with a defined sample size and ground truth for efficacy.

However, it does describe a usability study with specific acceptance criteria.

Here's a breakdown of the information based on the provided document, addressing your specific questions to the best extent possible given the information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Usability Study:
  • Sample Size: 116 adult subjects
  • Data Provenance: Not specified, but described as "diverse race, age, and educational background," suggesting a general population. This was a prospective study conducted by a "third party group."
• Performance Data (Technical): Not applicable for a typical "test set" in the context of clinical efficacy; this refers to technical compliance testing.

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

• Usability Study: The "ground truth" for the usability study was the actual user comprehension of instructions. It was evaluated via "user instruction questionnaire" and "self-selection" pass rates. This doesn't involve "experts" establishing ground truth in the clinical sense (e.g., diagnosing a condition). It's a measure of user understanding.
• Performance Data (Technical): The compliance was assessed against established standards (e.g., IEC standards), which represent accepted technical benchmarks. The document doesn't specify individual experts for establishing this ground truth, but rather adherence to recognized engineering and safety standards.

4. Adjudication Method for the Test Set

• Usability Study: This is not applicable in the typical sense of clinical adjudication (e.g., 2+1 for medical diagnoses). The pass rates were determined based on a questionnaire and self-selection criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. This document describes a medical device (laser cap) for hair growth, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant or reported here.

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

• Not applicable. This is a physical medical device, not an algorithm. The "performance data" refers to the device's technical specifications and safety compliance, not an algorithm's diagnostic performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For Usability Study: User comprehension as measured by questionnaire responses and self-selection behavior.
• For Technical Performance: Adherence to international standards (e.g., IEC 60601-1, 60825-1, ISO 10993).
• For Clinical Efficacy (Implied): The document points to substantial equivalence to predicate devices that have prior FDA clearance, implying that the efficacy of low-level laser therapy (LLLT) for androgenetic alopecia has been established by those predicate devices. The current submission relies on the "same or similar Laser Wavelength, Laser Power, Laser Energy Type, Output Mode, Treatment Time, Output Beam, Laser Field Treatment Area, Consumer Usage Focal Length" as the predicates. This is a claim of equivalence based on shared technological characteristics rather than new clinical outcomes data from the DermaScalp device itself.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

In summary: The document primarily focuses on demonstrating substantial equivalence to pre-existing cleared devices based on technological characteristics and safety standards, along with a usability study. It does not present new, independent clinical efficacy data with a defined "ground truth" for hair growth established specifically for the DermaScalp Laser Cap in this 510(k) submission. The clinical efficacy is largely inferred from the equivalence to previously cleared predicate devices.

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The DermaScalp Laser Cap is indicated to promote hair growth in females with Androgenetic Alpopecia who have Ludwig-Savin Classifications I-II and who have Fitzpatrick Skin Types I to IV.

The DermaScalp MD Laser Cap and the DermaScalp MDX Laser Cap devices are a hands-free, portable, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Females. The DermaScalp Laser Cap devices provide distributed red laser light dispersing from a "Concave" scalp covering utilizing laser modules with a 650 nm wavelength, <5 mW output power, producing a continuous wave "CW" output beam. The "Concave" scalp covering is designed to maximize the delivery of the coherent laser light to effectively cover the entire scalp of the user during treatment.

This document describes the DermaScalp Laser Cap, a device for promoting hair growth in females with Androgenetic Alopecia. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance study with detailed acceptance criteria and a clinical trial.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of clinical efficacy endpoints (e.g., hair count increase, patient satisfaction). Instead, it relies on demonstrating that the new device has "the same or similar Laser Wavelength, Laser Power, Laser Energy Type, Output Mode, Treatment Time, Output Beam, Laser Field Treatment Area, Consumer Usage Focal Length as the FDA Cleared predicate devices."

The performance data listed confirms adherence to safety standards and comparison to predicate device specifications.

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

The document does not describe a clinical "test set" in the context of a prospective clinical study directly comparing the new device's efficacy. The performance data presented refers to technical performance testing (e.g., electrical safety, EMC, laser classification, adherence to design specifications). Therefore, there's no clinical sample size or data provenance (country, retrospective/prospective) for a clinical test set in this submission. The device is cleared based on substantial equivalence to existing devices.

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

This is not applicable as there was no clinical test set for which ground truth needed to be established by experts for efficacy evaluation. The "ground truth" for the technical performance was based on engineering and safety standards (IEC, ISO).

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring 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

Not applicable. This device is a laser therapy cap, not an AI-powered diagnostic tool requiring human reader interpretation or MRMC studies.

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

This is also not applicable. The device is a physical therapeutic device, not an algorithm. The "performance data" section indicates engineering and safety tests were performed, which could be considered standalone performance for the device's technical specifications.

7. The Type of Ground Truth Used

For the technical performance of the device, the ground truth used was adherence to:

• International Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC safety), IEC 60825-1 (laser safety classification), and ISO 10993-1:2009 (biocompatibility).
• Design Specifications: The device was tested to confirm compliance to its design specifications.

For the clinical intended use, the "ground truth" for demonstrating substantial equivalence was effectively the clinical efficacy and safety profile of the predicate devices, which were already FDA cleared. The new device is argued to be safe and effective because its technological characteristics are the same or similar.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the traditional sense for algorithm development.

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

Not applicable, as there is no training set.

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