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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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