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The NOOANCE LED AND LASER HELMET is indicated to promote hair growth in males with androgenetic alopecia who have HamiltonNorwood Classifications of Ila-V and Fitzpatrick Classification of Skin Phototypes I to IV, and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.

The NOOANCE LED AND LASER HELMET is an over-the-counter device designed to promote hair growth in person with androgenetic alopecia in women and men. The device is a combination of 650±5nm low-level laser diodes and 650±5nm light emitting diodes. Red light of specific spectrum combined with low-lever laser directly irradiated into hair follicles has been shown to help promote hair growth. It has two models, M-120 and M-282 PRO. The difference between them is the number of laser diodes (LDs) and light-emitting diodes (LEDs). The model M-120 is a combination of 51 class 1C low-level LDs and 69 LEDs. And the model M-282 PRO has 82 class 1C low-level LDs and 200 LEDs.

The device has two working modes. Mode 1 is continuous which has no frequency setting. Mode 2 is pulse with a frequency. User long presses the ON/OFF button to turn on the device and tap the ON/OFF button to select the preferred mode. Then press the start/pause button to start the treatment, treatment time is fixed for 25 minutes. The device is designed to automatically pause therapy if it is removed from the head and resume therapy when positioned on the head within 5 minutes and the start/pause button is pressed. Once the treatment complete, the device will turn off automatically with two "beep" sounds.

Here's an analysis of the provided text regarding acceptance criteria and study proving device performance:

Crucial Observation: The provided document is an FDA 510(k) clearance letter and its accompanying summary. It explicitly states in section 8.2: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, a study demonstrating the device meets performance criteria for hair growth promotion (which would typically involve clinical data) has not been provided or deemed necessary for this 510(k) clearance. The acceptance criteria and "study" described below refer primarily to the non-clinical performance and safety testing.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: For all non-clinical performance tests (electrical safety, EMC, photobiological safety, laser safety), the "test sample is the final, finished product." This generally implies that a representative number of units (typically 1-3, but not explicitly stated as a statistical sample for a clinical trial) were subjected to these engineering and safety tests.
• Data Provenance: The tests are described as lab bench testing performed on the final product. The document does not specify the country of origin where these lab tests were conducted. The application is from Shenzhen, China, so it's likely the tests were conducted there or by a certified lab associated with the manufacturer. The data is retrospective in the sense that results are reported after the testing has been completed.

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

• Not Applicable in the traditional sense of clinical ground truth. Since no clinical study was conducted for efficacy claims relating to hair growth, there were no "experts" establishing a clinical ground truth for a test set of patients.
• The "ground truth" for these tests comes from adherence to international standards (e.g., IEC 60601, IEC 62471, IEC 60825-1). The experts involved would be the test engineers and certification bodies performing and validating the adherence to these specific technical standards. Their qualifications would be in electrical engineering, safety testing, and compliance with the specified standards.

4. Adjudication Method for the Test Set

• None. As this is non-clinical safety and performance testing, there is no need for a clinical adjudication method (like 2+1 or 3+1 consensus). The "adjudication" is simply whether the measured performance passes or fails the pre-defined criteria of the relevant international standards.

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

• No. An MRMC study is relevant for evaluating the performance of AI/CAD systems in medical imaging, often comparing human reader performance with and without AI assistance. This device is a direct-to-consumer LED/Laser helmet for hair growth, not an AI diagnostic tool. Therefore, an MRMC study was neither conducted nor applicable.

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

• No. This device is a physical therapeutic device, not an algorithm. There is no "standalone" algorithm performance to evaluate. The device's performance is its physical output (light wavelength, irradiance, fluence) and safety features, which were tested against engineering standards.

7. The Type of Ground Truth Used

• Engineering and Safety Standards: The "ground truth" for the non-clinical testing is compliance with established international medical device safety and performance standards (e.g., IEC 60601 series, IEC 62471, IEC 60825-1). For biocompatibility, it was established by similarity to a previously cleared predicate device. For software, ground truth was adherence to FDA guidance.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data for model development.

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

• Not Applicable. See point 8.

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NutraStim Hair Laser Helmet is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.

NutraStim Hair Laser Helmet is a low-level laser device and is intended/indicated for over- the -counter use. The device emits laser light with the intention to promote hair growth. The device provides timed treatments of distributed laser light to 100% of the scalp at 650 +/- 5 nanometers. The lasers are configured inside a helmet, designed for hands-free operation during treatment. The helmet is for portable use with rechargeable battery and adapter.

The provided document describes the NutraStim Hair Laser Helmet, a low-level laser device intended to treat Androgenetic Alopecia and promote hair growth. The device is being submitted for 510(k) clearance, asserting substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting study based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of pass/fail metrics with specified thresholds for clinical efficacy. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and safety standards.

However, we can infer some key performance and safety characteristics against which the device was evaluated, and its reported performance:

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

The document mentions a "lay-user study and self-selection study" but does not specify the sample size used for this test set.

The data provenance is not explicitly stated in terms of country of origin. The study was conducted with "Institutional Review Board (IRB) approval and oversight," which typically implies prospective data collection, but this is not explicitly confirmed as "prospective" or "retrospective" in the text. Given the nature of a "lay-user study and self-selection study" for device usability, it's highly probable it was a prospective study where participants interacted with the device and its instructions in a controlled setting.

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

For the lay-user and self-selection study, the concept of "ground truth" as it relates to expert medical diagnosis or outcome (e.g., hair growth assessment by radiologists) is not applicable here. The "ground truth" for this usability study would be the observable ability of lay users to correctly understand instructions and self-select.

There is no mention of experts being used to establish a medical or diagnostic ground truth for the device's efficacy. The study focused on usability and understanding of instructions.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the lay-user and self-selection study. Adjudication, such as 2+1 or 3+1, is typically used for ambiguous or complex diagnostic assessments, which is not the nature of this usability study. The determination of whether a user "successfully follow[ed] the instructions" or "properly self-select[ed] themselves" likely came from direct observation and analysis of their actions and responses during the study.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a direct-to-consumer medical device (infrared lamp/laser for hair growth) and does not involve human readers interpreting images or data, nor does it involve AI assistance in the way a diagnostic AI would. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not relevant here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is a physical laser helmet and does not involve an algorithm or AI in the traditional sense. Its performance is inherent in its physical parameters (wavelength, power, treatment protocol) and its interaction with the human scalp. Therefore, a "standalone algorithm-only" performance study is not applicable. The "standalone" performance would be its direct physical output characteristics, which were tested against engineering standards (e.g., IEC 60825-1 for laser classification, output per diode).

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

For the lay-user and self-selection study, the ground truth was based on the observable actions and stated understanding of the lay users regarding the product labeling and user manual. It's an assessment of user comprehension and usability, rather than a clinical ground truth for hair growth outcomes.

The broader "performance data" supporting substantial equivalence relies on:

• Engineering and Safety Standards Compliance: Confirmed by testing to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60825-1, and ISO 14971.
• Comparison to Predicate Device Specifications: Wavelength, output, laser classification, number of diodes, treatment protocol, etc., are directly compared to those of legally marketed predicate devices, implying that the established performance and safety profiles of these predicates serve as a de facto "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

This document describes a premarket notification for a medical device that does not use machine learning or AI algorithms in its core functionality. Therefore, the concept of a "training set" for an algorithm is not applicable. The data presented supports its safety and technological equivalence, not the training of an AI model.

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

As there is no training set for an AI algorithm, this question is not applicable.

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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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