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The Theradome LH40 (Theragrow) is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton 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-1, II-2; both with Fitzpatrick Skin Types I to IV.

The Theradome LH40 (Theragrow) laser helmet is a low level laser therapy (LLT) device containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles to promote hair growth via photobiostimulation of the scalp. The lasers are contained inside a lightweight, one-size-fits-all helmet. The Theradome LH40 device 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 is complete.

The provided document K180460 is a 510(k) Premarket Notification by Theradome, Inc. for their Theradome LH40 (Theragrow) device. This document focuses on demonstrating substantial equivalence to existing predicate devices for an expanded indication for use, specifically to include male pattern baldness.

Crucially, the document states: "Clinical testing was not required to support a substantial equivalence determination for the Theradome LH40 device." and "Performance testing was not required to support a substantial equivalence determination for the Theradome LH40 device."

Therefore, based on the provided text, there is no detailed information about acceptance criteria or a specific study proving the device meets those criteria through performance testing or clinical trials. The FDA's substantial equivalence determination for this submission was based on the device having the same technological characteristics and intended use as previously cleared devices.

Here's an breakdown of the requested information based only on the provided document:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

Since no new performance or clinical data was required for this specific submission, the "acceptance criteria" here refers to the device's technological characteristics being equivalent to the predicate devices and fitting its expanded indications for use.

Study Details (or lack thereof, based on provided document)

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

   • N/A. The document explicitly states: "Clinical testing was not required to support a substantial equivalence determination for the Theradome LH40 device." This means no new clinical test set was used for this specific submission. The determination was based on equivalence to predicate devices, which would have had their own clinical data.

2. 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):

   • N/A. No new test set, thus no new ground truth establishment by experts for this submission.

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

   • N/A. No new test set.

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:

   • N/A. This device is a low-level laser therapy (LLLT) helmet for hair growth, not an AI-assisted diagnostic tool.

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

   • N/A. This is a hardware device, not an algorithm, and no new standalone performance study was conducted for this submission.

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

   • N/A. No new ground truth data was generated for this specific submission. The substantial equivalence is based on the predicate devices' previously established safety and effectiveness, which would have involved clinical outcomes data or other relevant methods to establish their initial ground truth.

7. The sample size for the training set:

   • N/A. This device does not involve a "training set" in the context of machine learning or AI.

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

   • N/A. Not applicable for this type of device and submission.

Summary of the K180460 Submission:

This 510(k) focuses on a "substantial equivalence" claim. The submitter successfully argued that the Theradome LH40 (Theragrow) device, for its expanded indications to include male pattern baldness, is essentially the same as its own previously cleared devices (K161046 Theradome LH40 Evo and K171775 Theradome LH80 Pro) in terms of technology, operation, and safety profile. Because the core technological characteristics were unchanged from its predicate, and the expanded indication falls within a similar scope to what was previously cleared (promoting hair growth for Androgenetic Alopecia), the FDA determined that new performance data or clinical trials were not necessary for this specific 510(k) clearance.

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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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