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MEN - The GroWell BT Hair Growth System ("GroWell") is designed to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of Ila to V. WOMEN - The GroWell is designed to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin classifications of I-II. The GroWell is approved for Fitzpatrick skin types I-IV.

The GroWell BT Hair Growth System consists of 24 proprietary red light diode lasers and 39 proprietary red light super-luminescent diodes configured in a flexible panel which is inserted in an adult, baseball-style cap. The GroWell contains 655nm laser and LED diodes, which generates light after being excited by the internal power supply, the light is controlled and output by the control device, and directly and effectively irradiated to the treatment site, so as to achieve therapeutic effect. The GroWell's conbination of diode lasers and non-laser LED's provides for a full coverage of the head: i.e, the scalp area roughly from the top of the head to the top of the ears. The GroWell session will be "paused" and the light array will automatically turn off if the user removes the GroWell during use, and will resume when it is replaced on the 25 minute session, the lights will turn off and the GroWell will emit two audible beeps to signal that the therapy is complete.

The provided text is a 510(k) summary for the GroWell BT Hair Growth System. It states that non-clinical testing was conducted, but explicitly mentions no clinical data was used for performance verification. Therefore, it is impossible to infer acceptance criteria or details about a study proving the device meets those criteria from the provided document.

The document lists standards that the device complies with, but these cover general safety, electromagnetic compatibility, and biocompatibility, not performance related to hair growth efficacy.

Here's a breakdown of why the requested information cannot be provided from the text and what can be extracted:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: The document states "The clinical test is not applicable, there's no clinical data." This means there were no clinical performance acceptance criteria established or met.
• Sample sized used for the test set and the data provenance: Not applicable as there was no clinical test set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What can be extracted from the text regarding device verification:

The document states: "Non-clinical testing have been conducted to verify that the GroWell meets all design specifications which supports the conclusion that it's substantially equivalent to the predicate demonstrate that the subject device complies with the following standards:"

These standards relate to safety and electrical performance, not efficacy of hair growth.

• IEC 60601-1 Edition 3.2 2020-08: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
• IEC 60601-1-2 Edition 4.1 2020-09: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
• IEC 60601-1-11 Edition 2.1 2020-07: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral - Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
• IEC 62471 First edition 2006-07: Photobiological safety of lamps and lamp systems.
• IEC 60825-1: 2014: Safety of laser products - Part 1: Equipment classification, and requirements.
• Biocompatibility: Evaluated as per ISO 10993-1 Fifth edition 2018-08, and tested as per ISO 10993-5 Third edition 2009-06-01, ISO 10993-10 Fourth edition 2021-11 and ISO 10993-23 First edition 2021-01.
• Software evaluation: As per FDA guidance "Content of Premarket Submissions for Device Software Functions."

The conclusion provided is based on "analysis and tests" (referring to the non-clinical tests listed) and suggests substantial equivalence to predicate devices because of similar indications for use and technological characteristics (light source, design, wavelength, energy per diode). The differences noted (power supply, number of diodes, dimensions, and weight) were deemed not to raise safety or effectiveness issues due to compliance with international standards and core function (light output) not being affected.

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The igrow-II Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.

The Igrow-II Hair Growth System consists of 21 red visible light, diode lasers and 30 red light super-luminescent diodes configured within an outer helmet and protective inner. The use of diode lasers and non-laser LEDs provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down. by emitting an audible beep pattern.

The provided text is a 510(k) Summary for the iGrow-II Hair Growth System. It describes a clinical study to demonstrate the device's performance. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical thresholds in the typical sense for a diagnostic device. Instead, it describes efficacy in terms of hair growth and safety. The primary performance metric is the increase in terminal hair counts and effectiveness against a placebo.

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not explicitly state the exact number of subjects in the test set or placebo group. It uses the phrase "All subjects self-administered treatments..." and "All of the subjects showed a positive result for an increase in terminal hair counts." indicating a cohort of subjects. It also mentions "a multi-center, randomized, double blinded, placebo controlled, prospective trial." Without a specific numerical count, the exact sample size remains unclear from this document alone.
• Data Provenance:
  • Country of Origin: United States ("two sites in the United States").
  • Study Design: Prospective, multi-center, randomized, double-blinded, placebo-controlled trial.

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

The document does not provide information about experts establishing ground truth for the test set. The efficacy assessment centers on objective measures such as "increase in terminal hair counts" and "decrease in terminal hair counts," implying quantitative measurement rather than subjective expert consensus on the images themselves.

4. Adjudication method for the test set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set. The assessment appears to be based on direct measurement of terminal hair counts.

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

This is not applicable. The iGrow-II Hair Growth System is a low-level light therapy device (infrared lamp) for promoting hair growth, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

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

This is not applicable. The iGrow-II Hair Growth System is a physical device used by individuals for hair growth, not an algorithm.

7. The type of ground truth used

The ground truth for evaluating device efficacy was based on objective measurement of "terminal hair counts." This implies a quantitative assessment of hair growth, likely through direct counting or imaging analysis, rather than expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic study.

8. The sample size for the training set

The document mentions "Adequate data, from prior testing, was already available to the sponsor, validating the efficacy of the iGrow-II Hair Growth System, obviating the need to test lasers versus LEDs." However, it does not specify a separate "training set" or its sample size in the context of a new clinical trial for this specific submission. The details provided pertain to the prospective controlled trial described.

9. How the ground truth for the training set was established

As there's no explicitly defined "training set" for the current submission's clinical trial, details on how its ground truth was established are not provided. The phrase "prior testing" suggests earlier studies, but their methodology for establishing ground truth is not elaborated upon in this document.

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The igrow-II Hair Growth System is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and Fitzpatrick Classification of Skin Phototypes of I-IV

The Igrow-II Hair Growth System consists of 21 red visible light, diode lasers and 30 red light super-luminescent diodes configured within an outer helmet and protective inner. The use of diode lasers and non-laser LEDs provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.

The provided document is a 510(k) premarket notification for the igrow-II Hair Growth System. It describes the device, its intended use, and performance data related to its classification as an Over-The-Counter (OTC) device.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 30 male subjects.
• Data Provenance: The document does not specify the country of origin. The study appears to be prospective, designed to assess the real-world capability of average male retail customers.

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

The study described refers to "comprehension of user instructions and warnings and precautions" for OTC use, not a clinical efficacy study with ground truth established by medical experts for hair growth. The ground truth here is the successful comprehension of the device's usage instructions by the test subjects. The document does not detail how this "successful comprehension" was measured or adjudicated beyond stating an 83.33% pass rate. No medical experts (e.g., dermatologists or radiologists) were involved in establishing this specific "ground truth."

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The "pass rate" of 83.33% implies a direct assessment of each subject's comprehension against a predefined set of criteria, but the method of determining a "pass" or "fail" for each subject is not detailed.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a "Hair Growth System" (an infrared lamp), not an AI-powered diagnostic or assistive tool. The study described focuses on user comprehension for OTC classification, not a comparative effectiveness study involving human readers or AI.

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

This question is not applicable. The device is a physical infrared lamp system, not an algorithm. The "performance data" refers to user comprehension of its operation for OTC classification, not an algorithm's performance.

7. The Type of Ground Truth Used

The "ground truth" for the performance data presented is the successful comprehension by test subjects of user instructions, warnings, and precautions related to the device's operation. This is in the context of obtaining an Over-The-Counter (OTC) classification, indicating the device can be used safely and effectively by consumers without professional medical guidance.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or algorithm development. The 30 male subjects were part of the testing for OTC comprehension.

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

This question is not applicable, as there is no mention of a training set or associated ground truth establishment for an algorithm within the provided text. The study described is a human factors/usability assessment for OTC classification.

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The igrow-II Hair Growth System is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Phototypes I to IV.

The Igrow-II Hair Growth System consists of 21 red visible light, diode lasers and 30 red light super-luminescent diodes configured within an outer helmet and protective inner liner. The use of diode lasers and non-laser LEDs provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down. by emitting an audible beep pattern.

Here's a breakdown of the acceptance criteria and study information for the igrow-II Hair Growth System, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: Not explicitly stated as a number, but the study refers to "subjects" and "all of the subjects" in the active group demonstrating effectiveness, implying a sufficiently powered sample for the observed effect.
   • Data Provenance: Prospective, multi-center, randomized, double-blinded, placebo-controlled trial conducted at two sites in the United States.

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

   • This information is not provided in the summary. The "ground truth" seems to be based on an objective measurement: "increase in terminal hair counts," which would likely be quantified measurements rather than expert consensus on images.

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

   • Adjudication method is not explicitly stated. The "ground truth" is based on "increase in terminal hair counts" as a primary outcome.

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, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This study is evaluating the device itself, not AI assistance for human reading.

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

   • Yes, a standalone performance study was done. The device (igrow-II Hair Growth System) was tested on its own, with subjects self-administering treatments, and its efficacy was measured against a placebo device. There is no human-in-the-loop component mentioned for interpreting results or guiding the device's action, only for administering the treatment.

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

   • The primary ground truth used was outcomes data, specifically "increase in terminal hair counts."

7. The sample size for the training set:

   • Not applicable / Not explicitly stated. This is a performance study of a physical device, not an AI/algorithm that requires a training set in the typical sense. The summary mentions "Adequate data, from prior testing, was already available to the sponsor, validating the efficacy of the igrow-II Hair Growth System." This likely refers to previous internal testing and development, not a formal training set for an algorithm.

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

   • Not applicable. See point 7.

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