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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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