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The Theradome Laser Helmet LH40 EVO is an over the counter (OTC) device indicated to treat androgenetic alopecia, to promote hair growth in female pattern hair loss (FPHL) on the Ludwig and Savin Hair Loss Scale I-II, Fitzpatrick Skin-Types I to IV.

Similar to the Theradome LH80 PRO, the iGrow-II and the HairMax LaserComb 41, the modified Theradome LH40 EVO laser helmet is a low level laser therapy (LLLT) device containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimulation of the scalp. The lasers are contained inside a lightweight, one-sizefits-all helmet.

The LH40 EVO utilizes 40 laser diodes to deliver laser stimulation to the entire scalp for hands-free operation during treatment. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the 20 minute treatment completes.

Here's a breakdown of the acceptance criteria and study information for the Theradome Laser Helmet LH40 EVO, based on the provided document:

This document is a 510(k) summary for a medical device (Theradome Laser Helmet LH40 EVO). It is a submission to the FDA demonstrating substantial equivalence to legally marketed predicate devices, not an independent clinical trial report proving the device meets clinical acceptance criteria through new clinical data. In this context, "acceptance criteria" primarily refers to meeting established safety and performance standards for devices of its type, and showing that modifications to a previously cleared device do not alter its safety or efficacy.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission focused on substantial equivalence, the "acceptance criteria" are not framed as specific clinical endpoints but rather as demonstrating compliance with regulatory standards and maintaining safety and effectiveness comparable to predicate devices despite modifications.

Study Details (Based on the 510(k) Summary)

It is crucial to understand that this document describes a nonclinical study demonstrating substantial equivalence for a modification to a previously cleared device. It explicitly states that "no animal or new clinical data was required to show safety, efficacy or substantial equivalence to the currently cleared model."

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. This submission relies on nonclinical testing (electrical, laser safety, risk analysis) and a comparison of technological characteristics to predicate devices. There is no "test set" of patient data in this 510(k) summary.
   • Data Provenance: The data provenance for the nonclinical tests would be the manufacturer's internal testing facilities or contracted testing laboratories that performed the IEC and ISO standard tests. It is not patient data from a specific country or retrospective/prospective in the clinical sense.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. As there's no clinical "test set" and ground truth related to patient outcomes, this detail is not provided. The "ground truth" for the nonclinical tests is defined by the requirements of the standards (e.g., IEC 60601-1, IEC 60825-1, ISO 14971).

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

   • Not applicable. No clinical test set or adjudication of patient results is mentioned.

4. 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. This device is a therapeutic laser helmet, not an AI-powered diagnostic or assistive device that would involve human readers or MRMC studies.

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

   • Not applicable. This is a therapeutic device, not an algorithm. Its performance is evaluated through its physical characteristics and adherence to safety standards.

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

   • For the nonclinical safety and performance aspects, the "ground truth" is defined by adherence to international and national standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 61959, ISO 14971) and comparison to the established characteristics of legally marketed predicate devices.
   • For the intended use and indications, the ground truth for the predicate devices (LH80 PRO, iGrow-II, HairMax LaserComb 41) would have been established through their own clinical studies or historical use, which supported their original clearance. This 510(k) argues the LH40 EVO does not deviate from these established truths.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of machine learning or clinical data for this device. The device itself is not an algorithm that learns from data.

8. How the ground truth for the training set was established:

   • Not applicable for the reasons mentioned above.

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