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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 LH80 PRO is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia 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-1, II-2; both with Fitzpatrick Skin Types I to IV.

The Theradome LH80 PRO for men and women is a low level coherent light therapy (LLLT) device utilised to promote hair growth. The coherent lights are contained inside a lightweight, one-size fits all helmet. The Theradome LH80 PRO uses 80 coherent light diodes in the helmet to deliver coherent light stimulation to the entire scalp for hands-free operation during treatment. An audible timer automatically turns the coherent lights off after the 20 minutes treatment is completed. This coherent light helmet is not constructed to be a safety helmet.

The provided text describes the Theradome LH80 PRO device and its FDA submission (K171775). While it states that "all acceptance criteria were met by the devices," and refers to compliance with IEC-60825-2007-03, it does not explicitly list specific acceptance criteria or present the full details of a study with performance metrics in a way that allows for a direct table comparing acceptance criteria to reported device performance.

Instead, the document primarily focuses on establishing "substantial equivalence" to predicate devices based on similar technological characteristics and intended use. It explicitly states "Brief Description of Clinical Testing: Not applicable." This indicates that a clinical study designed to test efficacy against specific hair growth metrics was not performed for this 510(k) submission.

Therefore, many sections of your request cannot be fully answered from the provided text. I will answer what is available and indicate when information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Performance testing was conducted to confirm compliance to design specifications; all functions have been verified to operate as designed. All acceptance criteria were met by the devices." It also notes compliance with standard IEC-60825-2007-03, which establishes the AEL (accessible emission limits) as 5 milliwatts maximum. However, specific, measurable "acceptance criteria" related to efficacy (e.g., percentage increase in hair count, reduction in hair loss rate) and corresponding reported performance from a specific study are not provided in this document. The focus is on safety and technical specifications, and substantial equivalence to a predicate.

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

• Sample size for the test set: Not applicable for clinical performance as "Clinical Testing: Not applicable" is stated. For the "self-selection and usability" tests, the sample size is not mentioned.
• Data provenance: Not specified for the usability tests. For the technical compliance, it's typically internal testing by the manufacturer.

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

• Not applicable as clinical efficacy studies with ground truth established by experts are explicitly stated as "Not applicable" for this submission (K171775). For usability, no information on experts is provided.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical efficacy test set is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document states "Brief Description of Clinical Testing: Not applicable."

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

• Not applicable. The Theradome LH80 PRO is a low-level light therapy device, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For the technical performance and safety aspects, the ground truth is established by adherence to recognized standards (e.g., IEC-60825-2007-03) and design specifications.
• For usability and self-selection, the ground truth would typically be user feedback or observation, but specific details are not provided.
• For clinical efficacy (e.g., hair growth), no ground truth data from a clinical study is included in this submission.

8. The Sample Size for the Training Set

• Not applicable, as this is a medical device for light therapy, not an AI/ML algorithm that requires a training set.

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

• Not applicable, as this is not an AI/ML algorithm.

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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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The Theradome Laser Helmet LH80 PRO is an over the counter (OTC)device indicated to treat androgenic alopecia, to Promote hair growth in females with female pattern hair loss (FPHL) on the Ludwig and Savin Hair Loss Scale I-II, Fitzpatrick Skin-Types I to IV:

The Theradome Laser Helmet LH80 PRO is a low level laser therapy (LLLT) device used to promote hair growth via photobiostimulation. The lasers are contained inside a lightweight, one-size fits all helmet. The LH80 PRO utilizes 80 laser diodes in the helmet 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 an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes two studies related to over-the-counter use for the Theradome Laser Helmet LH80 PRO. These studies are designed to demonstrate the device's appropriateness for consumer use by lay persons, not its clinical effectiveness in treating androgenic alopecia.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: For both the "Self-Selection Study" and the "Labeling Comprehension Study," the sample size was 31 participants.
• Data Provenance: The participants were recruited from the downtown San Francisco commuter train station (Bay Area Rapid Transit - BART) in the USA. The studies appear to be prospective as participants were selected and surveyed specifically for these studies.

3. Number and Qualifications of Experts for Ground Truth

• Self-Selection Study:
  • Number of Experts: At least one physician. The text states: "...their hair condition was also examined by a physician who then decided if the person actually had Androgenic Alopecia or not."
  • Qualifications of Experts: A "physician" is mentioned. Specific qualifications (e.g., years of experience, specialization like dermatology) are not provided.
• Labeling Comprehension Study:
  • Number of Experts: Not applicable, as the ground truth was based on participants' direct answers to questions about their comprehension, verified by study administrators.

4. Adjudication Method for the Test Set

• Self-Selection Study: The decision on whether a person actually had Androgenic Alopecia was made by a physician. This implies a single expert's judgment. There's no mention of multiple experts or specific adjudication methods (like 2+1).
• Labeling Comprehension Study: This study involved participants answering questions, and study administrators evaluating their responses. There's no mention of external experts or adjudication beyond the administrators' assessment of correct comprehension.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The studies mentioned are focused on user comprehension and self-assessment for OTC use, not clinical effectiveness or human-in-the-loop performance improvement with AI.

6. Standalone (Algorithm Only) Performance Study

No. The device is a physical laser helmet, not an algorithm. Therefore, a standalone (algorithm only) performance study as typically understood in the context of AI/software medical devices is not applicable and was not done. The studies focus on user interaction with the device's labeling and its intended OTC use.

7. Type of Ground Truth Used

• Self-Selection Study: The ground truth for whether a participant actually had Androgenic Alopecia was established by a physician's examination.
• Labeling Comprehension Study: The ground truth for correct comprehension was based on participants' answers to specific questions about the labeling, assessed by the study administrators.

8. Sample Size for the Training Set

Not applicable. The provided studies are for evaluating consumer comprehension and self-assessment of an over-the-counter device, not for training a machine learning algorithm. Therefore, there is no training set mentioned or implied.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for it.

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The Theradome Laser Helmet LH80 PRO is intended to treat androgenic alopecia by promoting hair growth.

The Theradome Laser Helmet LH80 PRO is a prescription use therapeutic device indicated to promote hair growth in females, with androgenic alopedia, having Ludwig and Savin Hair Loss Scale classification I-II and Fitzpatrick Skin-Types I to IV.

The Theradome Laser Helmet LH80 PRO is a low level laser therapy (LLT) device used to promote hair growth via photobiostimulation. The lasers are contained inside a lightweight, one-size fits all helmet. The LH80 PRO utilizes laser diodes in the heimet 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.

The provided text is a 510(k) summary for the Theradome Laser Helmet LH80 PRO. It describes the device, its intended use, indications for use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, especially in terms of clinical performance or a multi-reader multi-case study.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

• Type of Device: The Theradome Laser Helmet LH80 PRO is a low-level laser therapy (LLT) device intended to promote hair growth. This type of device typically relies on clinical studies to demonstrate efficacy, but this document does not present such a study.
• Focus of the Submission: The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (RF Midwest LLC MEP-90 Hair Growth Stimulation System K091496) based on technological characteristics, intended use, and indications for use.
• "Performance Characteristics" Section: This section mentions "Testing to IEC 60601-1 and 60601-1-2 confirm the device's safety and electrical compatibility" and "Testing to IEC 60825-1 certifies the laser system to classification 3R, same as predicate device." It also states, "Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed." These are safety and engineering performance tests, not clinical efficacy studies with specific acceptance criteria as you've outlined.

Given the limitations of the provided text, I can only address the questions where information is explicitly available or directly inferred.

Acceptance Criteria and Study for Theradome Laser Helmet LH80 PRO

The provided 510(k) summary does not disclose specific clinical acceptance criteria for hair growth efficacy or a study proving those criteria. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through safety, electrical compatibility, and laser classification testing, rather than an independent clinical efficacy trial with predefined performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary explicitly states "Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed." This refers to engineering and functional performance, not clinical outcome performance.

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

• Sample Size for Test Set: Not applicable / Not mentioned for clinical efficacy. The performance tests mentioned (IEC standards, design specifications) are typically conducted on a limited number of device units for engineering verification, not a clinical "test set" in the context of patient data.
• Data Provenance: Not applicable for clinical data. The mentioned tests are engineering/safety in nature and would be conducted in a lab environment.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. The document does not describe a clinical study requiring expert assessment for ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The document does not describe a clinical study or expert review process that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, an MRMC study was not described or conducted, as this device does not involve image interpretation or diagnostic performance that would necessitate such a study.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

• Was a standalone study done? Not applicable. This device is a therapeutic (LLT) device, not an AI algorithm. Its performance is directly tied to its physical operation and biological effect, not an algorithmic interpretation task.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable for clinical efficacy. For the safety and performance tests mentioned (IEC standards, design specifications), the "ground truth" would be the engineering specifications and compliance requirements of the respective standards.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The device does not involve machine learning or AI that would require a training set.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

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