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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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Neuhat Hair Growth System is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV.

ibeauty.com Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV.

The System includes NEU180 and NEU300 two models.

NEU180 consists of 50 laser diodes with wavelength at 655mm, power ≤5mW, and 130 red light diodes with wavelength at 650 nm, power ≤5mW.

NEU300 consists of 100 laser diodes with wavelength at 655nm, power ≤5mW, and 200 red light diodes with wavelength at 650 nm, power ≤5mW.

The System is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an adapter.

The provided text is an FDA 510(k) summary for a medical device called "Neuhat Hair Growth System" (or "ibeauty.com Laser Cap"). This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria for a novel AI/device performance.

Therefore, the information required to answer your specific questions about acceptance criteria for an AI/device, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance is not present in this document.

This 510(k) summary for the Neuhat Hair Growth System primarily discusses:

• Device Description: It describes the two models (NEU180 and NEU300) with their laser and LED diode counts, wavelengths, and power.
• Indications for Use: It specifies the target population (males with Norwood-Hamilton classifications IIa-V and females with Ludwig-Savin classifications I-II, and Fitzpatrick Skin Phototypes I-IV) for promoting hair growth.
• Comparison to Predicate Devices: It provides a comprehensive comparison of technological characteristics (intended use, users, location, type of light, wavelength, number of diodes, energy, treatment time, applicable people/skin types, helmet/cap design, biocompatibility features) to two predicate devices (K210169 and K200464) to show substantial equivalence.
• Performance Data (Non-Clinical): It lists the biocompatibility testing (ISO 10993-5 and ISO 10993-10) and electrical and EMC safety testing (various IEC 60601 and IEC 62471 standards) that were performed and passed.

In summary, this document does not contain the type of data or study design (e.g., clinical trial data, AI performance metrics, expert adjudication details) that would allow for a complete answer to your request. The purpose of this 510(k) is to demonstrate that the device is as safe and effective as a legally marketed device, not to present a new clinical efficacy study with specific performance targets.

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ID-500 iRestore Hair Growth System: iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V and in females who have Ludgwig-Savin Classifications of I to II. All users should also have Fitzpatrick Skin Types I to IV.

The ID-500 iRestore Hair Growth System are two low-level laser/light systems operating at different wavelengths. The ID-500 iRestore Hair Growth System consists of laser and LED operating at 655 ± 10 nanometers. The physical configuration of the device is that of a helmet containing an inner and outer liner, stabilized with a silicone pad lined fixation ring. The systems operate on line voltage at 100 or 240 volts. The helmet's inner liner permits full adjustment to any head shape by means of non-toxic silicone pad. The helmet contains 5-millwatt-diode lasers and 5-milliwatt, super luminescent diodes, that emit red light.

The provided text describes the ID-500 iRestore Hair Growth System and its substantial equivalence to a predicate device, the iRestore Professional 282. However, it does not include detailed acceptance criteria for a device performance study in terms of clinical outcomes (e.g., hair count increase) or a study proving the device meets those clinical criteria. Instead, the document focuses on non-clinical performance data demonstrating safety and electrical/laser compliance.

Therefore, many of the requested elements for a clinical performance study (like sample size for test sets, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not available in this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

The document primarily discusses acceptance criteria related to safety and engineering standards, not clinical efficacy.

2. Sample size used for the test set and the data provenance:
This information is not provided as there is no description of a clinical performance study with a test set of human subjects. The "test set" here refers to the samples used in the non-clinical tests (e.g., cytotoxicity tests would use cell cultures or animal models, electrical safety tests would use the device itself). The document does not specify details about these samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there is no mention of a human-centric performance study where experts would establish a ground truth for clinical outcomes like hair growth. The "ground truth" for the non-clinical tests would be defined by the standards themselves (e.g., a cytotoxicity assay result being below a certain threshold).

4. Adjudication method for the test set:
This information is not applicable for the same reasons as above.

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 information is not applicable. The device described is a low-level laser/light therapy system for hair growth, not an AI-powered diagnostic tool requiring human reader interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is not an algorithm.

7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by the harmonized standards (ISO, ANSI, IEC, ASTM) and FDA guidance documents that the device was tested against. For example:

• Safety standards: Passing specific thresholds for electrical leakage, laser emission limits, or biocompatibility responses.
• Software compliance: Adherence to defined software development and validation practices.
• Lifetime/Transportation: Meeting predefined engineering specifications for durability and package integrity.

8. The sample size for the training set:
This information is not applicable as the device is a hardware product, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.

Summary of the Study:

The document describes a non-clinical performance study focused on demonstrating the safety and engineering compliance of the ID-500 iRestore Hair Growth System. The study involved testing the device against various national and international standards related to biocompatibility, electrical safety, electromagnetic compatibility, home use environment, laser safety, software validation, product lifetime, and transportation durability. The results of these tests confirmed that the device met the design inputs and performance specifications required by these standards, supporting its safety and effectiveness from an engineering and manufacturing perspective, and its substantial equivalence to the predicate device. No clinical efficacy study or AI-related performance study is detailed in this document.

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The Hair Growth System (Model: KN-8000B/KN-8000C/KN-8000E) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications Ila-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.

The Hair Growth System (Model: KN-8000B/KN-8000D/KN-8000E) is hands-free, portable, noninvasive, low-level laser device, which consists of red visible light diode lasers and/or LEDs, to produce red light operating at 650nm wavelength (maximum output power of each is 5mW). The laser sources are arranged in a dot matrix arrangement in the inner of the helmet, which could take into account of every hair follicle and promote rapid hair growth. The device will automatically pause therapy if the user's head is moved outside of the zone of radiation and will resume therapy when the correct head position is reestablished.

The device could be powered by internal rechargeable li-on battery (Rated 7.2Vd.c. 2100mAh), and it can also be supplied by specified external adapter with rated Input 100-240Vac. 50/60Hz and rated Output 9Vdc 3A.

For KN-8000D and KN-8000E, the device emits an audible voice prompt when the treatment is going to start/pause/end, and the device is going to shut down.

This document is a 510(k) premarket notification for a medical device called "Hair Growth System" (Models: KN-8000B/KN-8000C/KN-8000D/KN-8000E). It seeks to demonstrate substantial equivalence to previously cleared devices.

The information provided does not include details about specific acceptance criteria, reported device performance measurements, sample sizes, ground truth establishment, or clinical study designs in the way typically expected for a detailed AI device study. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with recognized standards.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and performance standards. The "performance" is implicitly demonstrated through adherence to these standards and similarity to already-cleared devices.

The tables provided (pages 6-7) are comparison tables showing technical characteristics of the subject device against predicate devices, with "Verdict" indicating if they are substantially equivalent (SE) or have minor differences. These are not performance metrics in the typical sense for AI, but rather technical specifications.

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

The document explicitly states: "Clinical performance is not deemed necessary." (Page 10)

Therefore, there was no clinical test set with a specific sample size, nor information on data provenance for such a set. The submission focuses on non-clinical testing and substantial equivalence.

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

Since no clinical test set was used, there were no experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

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

Not applicable. This device is a standalone hardware device (infrared lamp/laser for hair growth), not an AI-powered diagnostic or assistive tool that would involve human readers or MRMC studies.

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

This refers to a standalone hardware device, not a software algorithm. Its "standalone performance" is assessed through compliance with electrical safety, EMC, biocompatibility, usability, and software verification standards. The comparison tables illustrate that its technical specifications (wavelength, output, number of diodes/LEDs) are within ranges or similar to those of its predicate devices, which have already been deemed safe and effective.

7. The Type of Ground Truth Used

Given that "Clinical performance is not deemed necessary," there was no "ground truth" in the sense of expert consensus, pathology, or outcomes data from a clinical trial for the subject device to evaluate its effectiveness. The ground truth for its safety and function is established by compliance with engineering and safety standards (e.g., IEC 60601-1, IEC 60825-1, ISO 10993) and the demonstrated substantial equivalence to predicate devices, which were presumably cleared based on their own safety and effectiveness data (either clinical or through substantial equivalence to even earlier devices).

8. The Sample Size for the Training Set

Not applicable. This is a hardware device submission, not an AI/machine learning algorithm that requires a training set.

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

Not applicable.

Summary of Device Evaluation in the Document:

The "Hair Growth System" was evaluated through:

• Lab bench testing for:
  • Electrical safety and performance (IEC 60601-1, IEC 60825-1, IEC 62471, IEC 60601-2-57)
  • Electromagnetic compatibility (IEC 60601-1-2)
  • Biocompatibility (ISO 10993-5, ISO 10993-10) for patient-contacting materials
  • Usability (IEC 62366)
  • Software verification and validation (FDA guidance for software in medical devices)
• Comparison to predicate devices (DermaScalp Laser Cap, Capillus devices, iRestore Hair Growth System, iRestore Professional 282) to establish substantial equivalence in terms of:
  • Intended Use
  • Device Type (LLLT)
  • Prescription status (OTC)
  • Waveform and Wavelength (655nm ±5nm, 655nm ±20nm for LED)
  • Amounts of laser diodes/LEDs
  • Laser radiation output (

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iHelmet Hair Growth System (LTD88Lite, LTD36Air, LTD160Pro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ila-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

iHelmet Hair Growth System consists of laser diodes that are spread throughout the helmet. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. The product will pause automatically treatment if the sensor detects that the head is not in close proximity to the sensor, and will resume again once close enough. At the end of the treatment, an audible tone beeps to indicate the treatment is over and then the helmet automatically shut off.

Here's an analysis of the provided text regarding the iHelmet Hair Growth System's acceptance criteria and studies, organized according to your requested points.

It's important to note that this document is a 510(k) summary for a medical device aiming for substantial equivalence to existing devices. As such, the "studies" described primarily focus on bench testing and comparisons to predicates to demonstrate safety and performance under established standards, rather than formal clinical effectiveness trials with human subjects. There is no mention of a traditional algorithm-based AI system with ground truth development in the context of the provided document. The device is a physical product (infrared lamp for hair growth), not a diagnostic AI system.

Therefore, many of your requested points regarding AI-specific criteria (e.g., ground truth establishment for a test set, AI vs. human reader effectiveness, adjudication methods) are not applicable or cannot be extracted from this documentation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on compliance with various international standards for medical electrical equipment, laser safety, and biocompatibility, as well as maintaining specific physical and operational parameters. The reported performance is the device's adherence to these standards and its performance within defined limits, making it "substantially equivalent" to predicate devices.

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

• Sample Size: Not applicable in the context of human subjects or a data test set for an AI model. The "test set" in this document refers to the physical device undergoing various bench tests and comparisons against engineering specifications and predicate devices. No specific "sample size" of a dataset for algorithmic evaluation is mentioned because this is not an AI diagnostic or analytical device.
• Data Provenance: Not applicable. The "data" here comes from direct measurements and compliance testing of the physical iHelmet device itself, against pre-defined engineering standards and benchmarks set by predicate devices.

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

• Not Applicable. This document does not describe the establishment of ground truth by experts for a dataset, as it pertains to a physical medical device (infrared lamp) for hair growth, not an AI system that interprets data or images. The "ground truth" for this device's performance is adherence to established engineering standards and safety limits, and demonstration of substantial equivalence to already cleared devices.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical trials or studies to resolve discrepancies among human readers or experts when establishing ground truth for diagnostic AI. This document describes bench testing and comparison studies of a physical device.

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. An MRMC study is not mentioned as this device is not an AI-assisted diagnostic tool for human readers. It is a direct-to-consumer medical device for hair growth.

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

• Not Applicable. This is not an algorithm. It is a physical device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on adherence to international consensus standards (e.g., IEC, ISO) for electrical safety, laser safety, biocompatibility, and performance, along with demonstrating substantial equivalence to previously cleared predicate devices.
• For biological parameters like hair growth, the ground truth for the predicate devices' effectiveness would have been established through clinical trials (but those trials are not part of this 510(k) submission, which relies on the predicate's prior clearance). The current submission focuses on demonstrating that the new device meets the same safety and performance profiles as the predicates.

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI system that requires a "training set" in the machine learning sense.

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

• Not Applicable. As there is no AI training set, there's no ground truth establishment for it.

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Hair Growth System, Models: SPARK-3 and SPARK-4 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwing -Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood -Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

Not Found

This document is an FDA 510(k) clearance letter for a "Hair Growth System", not a study report or clinical trial summary. Therefore, it does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving device performance.

The provided text only includes:

• General FDA clearance information.
• The device name, regulation number, regulatory class, and product code.
• The indications for use for the Hair Growth System.

It emphatically does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Information about MRMC studies, standalone algorithm performance, or the type of ground truth used.
• Details about training set size or how its ground truth was established.

Without a clinical study report or a summary of the performance data submitted for the 510(k) clearance, these questions cannot be answered from the provided text.

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The Hair Growth System (Model: KN-8000A) is a prescription use device intended for the prowth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.

The Hair Growth System Model: KN-8000A is a transportable, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in both Males and Females. It produces a red light, diode lasers operating at a 650-nanometer wavelength (maximum output power of each is 5 mW). The device mainly includes a host machine, light source and lifting bracket. The light source applicator was equipped with the access sensor device, it can power off the light source when the patient's scalp deviates from the work area.

The provided text is a 510(k) summary for the "Hair Growth System (Model: KN-8000A)" and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria for an AI/algorithm-driven device.

Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/algorithm performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details for an AI model.

The "Test Summary" section in the document only mentions:

• Electrical safety test (IEC 60601-1 and IEC 60825-1 standards)
• Electromagnetic compatibility test (IEC 60601-1-2 standard)
• Software verification and validation test (according to FDA guidance for software in medical devices)

These tests are related to the safety and fundamental performance of the device's hardware and software, but not to the clinical effectiveness or performance of an AI component in achieving a specific outcome (like hair growth based on algorithmic assessment). The device itself is described as a "low-level laser device" not explicitly an AI-driven system.

In summary, none of the requested information regarding AI/algorithm acceptance criteria and study details is present in the provided text. The document's purpose is to establish substantial equivalence for a physical device, not to describe the validation of an AI algorithm.

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The Grivamax Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II, males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

The Grivamax Hair Growth System consists of 272 diode lasers configured within an outer cap helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head i.e., the area commonly covered with stylized hair. The Grivamax Hair Growth System is powered by a lithium-ion battery pack that contains an embedded controller chip.

It appears there's a misunderstanding of the provided text. The document is an FDA 510(k) clearance letter for a medical device called the "Grivamax Hair Growth System," which is an infrared lamp to promote hair growth.

The document states very clearly in Performance Data section on page 4: "No clinical performance data was produced for this submission because the Grivamax Hair Growth System is the same device as the predicate, the Illumiflow Laser Cap, cleared under K162071. Both the Grivamax Hair Growth System and Illumiflow Laser Cap are the IDENTICAL same device offered for PRIVATE LABEL by the manufacturer, Cosmo Far East Technology Limited."

Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on its own clinical performance data within this submission. The clearance is based on its substantial equivalence to a predicate device for which performance data was previously submitted.

However, the document does describe an Over-The-Counter (OTC) Testing Program for consumer comprehension and usability. This is a study designed to meet acceptance criteria for informed self-selection, correct usage, and hazard comprehension for an OTC device. I will describe this study and its acceptance criteria as it is the only "study" described in the provided text.

OTC Testing Program: Acceptance Criteria and Study Details

The provided document describes an Over-The-Counter (OTC) Testing Program conducted to evaluate consumers' ability to understand and correctly use the Grivamax Hair Growth System without professional assistance. This is a crucial component for OTC medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

• Self-Selection: Making the correct decision to purchase the product or not, based on understanding the Intended Use.
• Usability: Correctly assembling and using the product.
• Comprehension: Understanding the hazards and maintenance procedures for the device.

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

• Sample Size: 40 subjects.
• Data Provenance: Not explicitly stated regarding country of origin, but the context implies it was conducted within the jurisdiction where the FDA regulates, likely the USA. The study design ("volunteer subjects," "interview conducted by interviewer") suggests a prospective study for this specific OTC testing.

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

• Ground Truth Establishment: The ground truth for this OTC test was based on the "correct" answers to 26 questions derived from the product's standard retail package and full owner's manual. The "experts" defining these correct answers would likely be the device manufacturer's design team and regulatory affairs personnel, who developed the manual and packaging, in conjunction with regulatory guidelines for consumer comprehension. No specific number or qualifications of "experts" are stated in this document for creating the questionnaire's correct answers, as it's assumed these would be inherent to the device's design and labeling.

4. Adjudication Method for the Test Set

• Adjudication Method: "If the questions were answered correctly, they were given a P for PASS. If any questions were answered incorrectly, they were given an F for FAIL." This indicates a simple Pass/Fail adjudication per subject based on answering all questions correctly. No multi-reader, multi-expert consensus or 2+1/3+1 methods are described, as this was a direct consumer comprehension test against predefined correct answers.

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

• No MRMC study was done focusing on clinical effectiveness. The device is cleared based on substantial equivalence to a predicate device, not on new clinical performance data from a comparative effectiveness study within this submission.
• The OTC testing was for consumer comprehension and usability, not for clinical efficacy or comparative effectiveness in promoting hair growth.

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

• Not applicable. This device is a physical infrared lamp for hair growth. There is no "algorithm" in the sense of AI or image analysis being tested for standalone performance. The "standalone" aspect here relates to the consumer's ability to use the device without professional assistance, which was tested by the OTC program.

7. The Type of Ground Truth Used

• Ground Truth: For the OTC testing, the ground truth was the correct answers to 26 questions derived from the device's retail packaging and owner's manual regarding its intended use, assembly, operation, hazards, and maintenance. This is a form of expert-defined truth based on the product's design and regulatory requirements for user comprehension.

8. The Sample Size for the Training Set

• Not applicable. This document describes an OTC testing program involving human subjects, not an AI/machine learning model that requires a "training set."

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

• Not applicable. As above, there is no AI/machine learning model or training set described in this document.

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iHelmet Hair Growth System (Model: LTD200S) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV.

iHelmet Hair Growth System consists of laser diodes that are spread throughout the helmet. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. The product will pause automatically treatment if the sensor detects that the head is not in close proximity to the sensor, and will resume again once close enough. At the end of the treatment, an audible tone beeps to indicate the treatment is over and then the helmet automatically shut off.

The provided text is a 510(k) summary for the iHelmet Hair Growth System (Model: LTD200S). It focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria based on clinical outcomes.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes for test and training sets, ground truth establishment, expert involvement, and MRMC studies are not explicitly provided in this regulatory document. This document primarily addresses safety and performance through bench testing and comparison to a predicate device.

Here's a breakdown of the information that can be extracted or inferred from the provided text, addressing your points where possible:

1. A table of acceptance criteria and the reported device performance

The document does not present clinical acceptance criteria for hair growth or efficacy. Instead, it relies on demonstrating substantial equivalence to a predicate device based on technical specifications and safety standards. The "acceptance criteria" here are compliance with recognized safety standards and similarity to the predicate device.

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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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