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The CurrentBody Skin Dual Light Hair Growth Helmet is indicated to promote hair growth in males with who have Norwood-Hamilton classifications of IIa-V or females with who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.

The CurrentBody Skin Dual Light Hair Growth Helmet (model:MZ-07A) is an over-the-counter device designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to promote hair growth in females who have Ludwig-Savin Classifications of I-II; both with Fitzpatrick Skin Types I-IV.

The device consists of 100 laser diodes with wavelength at 655±5nm, and 200 red light diodes with wavelength at 660±5nm.

The CurrentBody Skin Dual Light Hair Growth Helmet includes a hair-growing cap, a device base and a USB power cord. There are LEDs and lasers diodes inside the cap to emit visible red light, the device base acts as a support when the device is not used. There is a power button on cap to turn on/off the device, a digital display to show the remaining treatment time, an power indicator to show charging status and a USB port for charging.

The treatment parameter is pre-set by manufacturer, the device will auto off after treatment.

The provided FDA 510(k) clearance letter and summary for the CurrentBody Skin Dual Light Hair Growth Helmet (K251017) indicate that clinical performance testing was explicitly stated as "not needed" for this 510(k) submission. Therefore, the document does not contain information regarding acceptance criteria or a study that proves the device meets those criteria based on clinical performance data.

The submission relies on non-clinical performance testing to demonstrate substantial equivalence and safety/effectiveness. This non-clinical testing focuses on electrical safety, EMC, photobiological safety, battery safety, biocompatibility, and software validation.

Here's a breakdown of why the requested information about acceptance criteria and a clinical study proving performance cannot be extracted from this document, along with information that is available:

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

Since no clinical performance study was provided, there are no specific performance acceptance criteria for hair growth or efficacy reported in the document. The acceptance criteria for this submission are related to meeting established safety and performance standards through non-clinical testing.

Table of Acceptance Criteria (Non-Clinical) and Reported Device Performance:

Regarding a Clinical Study (Not Applicable for this Submission)

As stated in Section 7.2 of the 510(k) Summary:
"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, the following information, which would typically be included for a clinical study proving efficacy/performance, is not available in this document:

1. Sample sizes used for the test set and the data provenance: Not applicable.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
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: Not applicable (This is generally for diagnostic AI devices, not a therapeutic device like this).
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not applicable.
7. The sample size for the training set: Not applicable (referring to clinical training data for performance, not engineering/software validation training).
8. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance Claim Basis for Hair Growth:

The claim about promoting hair growth is based on:

• Substantial Equivalence: The primary strategy for clearance is demonstrating that the CurrentBody Skin Dual Light Hair Growth Helmet is substantially equivalent to legally marketed predicate devices (K231153: Neuhat Hair Growth System; K240456: Bosley Booster Laser Caps). The predicate devices were previously cleared for the same indication (promote hair growth in specific Norwood-Hamilton and Ludwig-Savin classifications with Fitzpatrick Skin Phototypes I-IV).
• Similarity in Design and Parameters: The submission highlights similarities in the intended use, indications for use, type of light (low-level laser and LED), wavelength (very close to predicates), number of diodes, energy per laser diode, and treatment time/irradiance (very close to predicates). The argument is that these similarities mean the subject device will have a similar therapeutic effect to the already-cleared predicate devices.
• Non-Clinical Data: As detailed in the table above, the non-clinical testing ensures the device meets safety standards (electrical, EMC, photobiological, battery, biocompatibility, software) which indirectly supports its safe use for its intended purpose without raising new questions of safety or effectiveness compared to the predicates.

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The Red Light Hair Growth Cap is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa-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 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I-IV.

The Red Light Hair Growth Cap is an over the counter (OTC) home-use, non-invasive device indicated to treat androgenetic alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa-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 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I-IV.

The Red Light Hair Growth Cap is a portable, therapeutic device whose purpose is to provide even, cool, narrow-band wavelengths of polychromatic light (660nm red light) produced by LEDs to treat androgenetic alopecia and promote hair grown.

The device comprises of a wearable soft textile cap, a controller, an AC adaptor and a USB cable. The device can be powered by the AC adaptor which connected to the mains directly, also it can be powered by a power bank. The device is operated by the controller. There are 2 buttons on controller, ON/Off button is used to turn on/off the device, time button is used for setting treatment time from 10 to 30 minutes, each press in 5-minute increments./decrements. The device will shut off automatically after reach treatment time.

The provided FDA 510(k) clearance letter and summary for the "Red Light Hair Growth Cap" do not contain the detailed clinical study information typically associated with acceptance criteria, reported device performance for clinical endpoints, sample sizes for test/training sets, expert qualifications, or adjudication methods for AI/software devices. This is because the device, an "Infrared Lamp" (a physical medical device), was cleared based on its substantial equivalence to predicate devices and extensive non-clinical (electrical safety, EMC, software verification/validation) testing, rather than a clinical effectiveness study.

The summary clearly states: "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, I cannot directly extract the requested information (points 1-9) in the manner typically expected for an AI/software medical device that undergoes rigorous clinical validation with specific performance metrics against a ground truth.

However, I can describe the acceptance criteria and study type that proves the device meets those criteria based on the provided document:

Acceptance Criteria and Study for the Red Light Hair Growth Cap

The Red Light Hair Growth Cap (LP-RJVGRW-BLK) received FDA 510(k) clearance based on its substantial equivalence to legally marketed predicate devices, combined with comprehensive non-clinical performance testing. The core "acceptance criteria" for this specific submission were centered around safety and effectiveness being comparable to existing devices and meeting established electrical and software safety standards.

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

Since this was a 510(k) based on substantial equivalence and non-clinical testing, the "acceptance criteria" are primarily related to safety standards and comparison to predicate device characteristics. There are no specific clinical performance metrics for "hair growth" reported in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set (Clinical): Not applicable. Clinical testing was explicitly stated as "not needed" for this 510(k). The evaluation relied on non-clinical engineering and software testing.
• Data Provenance: The document does not specify country of origin for any safety testing data, only that the sponsor is Shenzhen Idea Light Limited, China. The testing itself is non-clinical (lab-based engineering/software V&V).

3. 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)

• Not applicable. There was no clinical "test set" requiring expert ground truth establishment for clinical endpoints.

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

• Not applicable. There was no clinical "test set" requiring adjudication.

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 not an AI/software diagnostic tool; it is a therapeutic device that does not involve human readers interpreting output or AI assistance.

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

• Not applicable. This is a physical therapeutic device, not an algorithm.

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

• For the non-clinical testing, the "ground truth" refers to the established requirements and specifications of the referenced IEC standards (e.g., IEC 60601-1 for electrical safety) and FDA software guidance. Compliance with these standards served as the "ground truth" for safety and performance.
• For substantial equivalence for indications for use, the "ground truth" was the cleared indications for use of the predicate devices.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set" in the context of data-driven algorithm development.

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

• Not applicable, as there is no training set.

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Hair Growth Device 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 IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

The product is composed of main unit, USB cable, and silicone pad. The main unit consists of laser diodes that are spread throughout the helmet. Low-energy laser therapy (LLLT) is a safe and effective treatment for androgenic alopecia (AGA). The Hair Growth Device employs intelligent LLLT technology, utilizing a 650 nm, 5-milliwatt low-energy laser that penetrates the scalp surface to a depth of 3-5 mm, reaching the hair follicles. Hair Growth Device is a small over-the-counter, portable, noninvasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Males and Females. 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. Hair Growth Device consists of main unit, USB cable and silicone strap and no communication function. The device will then turn on and you'll hear an audible beep.

This FDA 510(k) clearance letter is for a medical device (Hair Growth Device) rather than a software algorithm used for interpretation/diagnosis. As such, the information typically requested for AI-powered diagnostic devices (e.g., test set sample size, expert qualifications, adjudication methods, MRMC studies, ground truth types for training/test sets, etc.) is not applicable or present in this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and non-clinical testing. It explicitly states, "No clinical test data was used to support the decision of substantial equivalence."

Therefore, I cannot provide the requested information about acceptance criteria for an AI algorithm's performance or details about a study proving such performance, as this document does not pertain to such a device or study.

However, I can extract the general acceptance criteria and the type of study performed to prove substantial equivalence based on the provided text, recognizing these are not related to AI performance.

Based on the provided FDA 510(k) clearance letter for the Hair Growth Device:

1. Table of Acceptance Criteria and Reported Device Performance:

• Product service life
• Software validation
• Biocompatibility evaluation
• Electromagnetic compatibility and electrical safety
• Safety of laser products
• Performance test |

Regarding the study that proves the device meets the acceptance criteria (note: this is a substantial equivalence study, not an AI performance study):

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set or patient data was used. The study primarily relies on comparison to predicate devices and non-clinical engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth was used for this substantial equivalence determination.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication 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 not an AI-powered diagnostic tool, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm. The device operates independently (Over-The-Counter).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. For substantial equivalence, the "ground truth" is established by compliance with recognized standards (e.g., IEC, ISO) and comparison to legally marketed predicate devices that have established safety and effectiveness.

8. The sample size for the training set: Not applicable. This is not an AI algorithm, so there is no training set in the machine learning sense.

9. How the ground truth for the training set was established: Not applicable. No AI training set.

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FAQ™ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.

FAQ™ 302 is a handheld rechargeable square shaped device designed for improving hair growth with 20 laser diodes (wavelength 650±10m) and 20 RED LED beads (640-660nm) on the inside surface.

By pressing the universal button, the user can power the device on, start treatment and change the intensity by quick-pressing the button again. Once the treatment is complete, the device is turned off by pressing and holding the universal power button for 3 seconds.

The device can also be connected wirelessly via Bluetooth to an FAQ App in order to manage treatment. After the treatment is completed, the device automatically powers off.

The device uses a non-detachable polymer lithium battery for power supply in compliance with IEC 62133-2:2017+A1:2021 standard.

Here's a breakdown of the acceptance criteria and study information for the FAQ™ 302 device, based on the provided FDA 510(k) summary:

This device (FAQ™ 302) is an Infrared Lamp intended to promote hair growth. The 510(k) summary explicitly states that clinical testing was considered not to be needed for this 510(k). Therefore, the provided document does not contain information about a study proving the device meets acceptance criteria related to its clinical effectiveness (i.e., promoting hair growth). Instead, the studies presented are non-clinical tests to demonstrate safety and performance equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since clinical efficacy was "considered not to be needed," the acceptance criteria are not for clinical effectiveness but rather for safety, electrical performance, software functionality, cybersecurity, and usability. The document focuses on demonstrating that the new device is substantially equivalent to predicate devices based on these non-clinical aspects.

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

• Biocompatibility Testing: The document does not specify the sample size (e.g., number of test specimens or replicates) for the biocompatibility tests.
• Electrical Safety and EMC Testing: The document does not specify the sample size used for these compliance tests, as these are typically conducted on a representative sample of the device itself rather than patient data.
• Software Verification and Validation: The document does not specify the number of test cases or data points for software validation.
• Cybersecurity: This involved an analysis, not a test set with patient data.
• Usability Study:
  • Sample Size: 15 adults
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is implied to be prospective as it's a "validation testing" that "was conducted."

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

• For all non-clinical tests (biocompatibility, electrical safety, EMC, software, cybersecurity): "Ground truth" in the sense of clinical expert consensus is not applicable. These tests rely on established engineering and scientific standards. The "experts" involved would be the testing engineers and scientists responsible for conducting and interpreting these standard-based tests. Qualifications are not specified, but they would be presumed to be competent in the relevant fields.
• For the Usability Study: The document does not mention experts establishing a "ground truth" for usability. The study assessed whether adult users could follow instructions.

4. Adjudication Method for the Test Set

• Not applicable as no clinical test set requiring expert adjudication was performed.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was considered not to be needed for this 510(k)." The device's substantial equivalence is based on non-clinical performance and a comparison of its technical specifications and indications for use with legally marketed predicate devices.

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

• Not applicable. This device is a hardware device (infrared lamp) with embedded software, not a standalone AI algorithm. The software verification and validation section relates to its internal software functionality, not an AI or standalone diagnostic/treatment algorithm.

7. Type of Ground Truth Used

• Biocompatibility, Electrical Safety, EMC: Ground truth refers to compliance with established international and national standards (e.g., ISO, IEC, AAMI compliance).
• Software: Ground truth refers to predefined software requirements and specifications, and the mitigation of identified software hazards.
• Cybersecurity: Ground truth refers to industry best practices, identified risks and vulnerabilities (including comparison with the National Vulnerability Database), and the effectiveness of mitigation strategies.
• Usability Study: Ground truth for this study was the ability of the users to follow the provided instructions to safely and appropriately use the device.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the context of learning from data to perform a diagnostic or treatment task. Software validation was performed but does not involve a training set as understood in AI/ML.

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

• Not applicable, as no training set was used for an AI/ML algorithm.

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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 HIGHERDOSE Red Light Hat is a home wearable light-emitting diode phototherapy device with proven wavelengths of light 650nm±10nm Red light, which are used to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classfications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to 1-4, 11-1, 11-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types 1 - 1V.

The HIGHERDOSE Red Light Hat is a home wearable light-emitting diode phototherapy device with proven wavelengths of light 650nm±10nm Red light, which are used to treat Androgenetic Alopecia and promote hair growth in males who have Nowood- Hamilton Classifications of Ila - 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 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

The device is designed as wearable product, and it consists of the main unit, the controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery.

The hat compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of cotton.

The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The HIGHERDOSE Red Light Hat cannot be operated while charging. The controller switches the LEDs ON/OFF. Switch the controller ON and allow the hat to run for 10 minutes treatment program. The cable for connecting with the controller is detachable.

The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

The provided text describes a 510(k) submission for the HIGHERDOSE Red Light Hat (HG-120K), seeking substantial equivalence to predicate devices for treating Androgenetic Alopecia and promoting hair growth.

However, the documentation does not contain information regarding a clinical study with acceptance criteria and reported device performance related to hair growth outcomes. Instead, it focuses on non-clinical performance testing (electrical safety, EMC, usability, software verification, and biocompatibility) to demonstrate safety and effectiveness for a device marketed as an Over-The-Counter Infrared Lamp.

The document explicitly states: "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." This means that the FDA's clearance for this device was based on a comparison to predicate devices and engineering/safety tests, not on new clinical data demonstrating its efficacy in hair growth.

Therefore, it is not possible to extract the requested information from the provided text regarding:

1. A table of acceptance criteria and reported device performance for hair growth.
2. Sample size and data provenance for a test set proving hair growth efficacy.
3. Number and qualifications of experts for ground truth establishment for hair growth.
4. Adjudication method for a hair growth test set.
5. MRMC comparative effectiveness study for human readers with and without AI assistance for hair growth.
6. Standalone performance of an algorithm without human-in-the-loop for hair growth.
7. Type of ground truth used for a hair growth study.
8. Sample size for a training set (as no AI algorithm for diagnosis/prognosis is implied).
9. How ground truth for a training set was established.

The document primarily addresses the substantial equivalence requirements by comparing the technical specifications and intended use of the HIGHERDOSE Red Light Hat with previously cleared infrared lamp devices, and by demonstrating compliance with relevant electrical and safety standards.

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The Hair Growth Comb (Model: SZ-23 ,SZ-23A,) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to 1-4, Il-1, Il-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

The Hair Growth Comb is (Model: SZ-23, SZ-23A) a comb-shaped device that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 650nm (±10nm) while the comb teeth simultaneously part the user's hair to ensure the light reaches the user's scalp. The device is designed as a handheld product, and it consists of the main unit, the charging dock and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.

This document is a 510(k) Summary for a medical device (Hair Growth Comb, Models SZ-23, SZ-23A). It provides information regarding the device's substantial equivalence to previously cleared predicate devices, primarily focusing on its technical characteristics and safety testing.

Crucially, this document states: "Clinical testing was not needed for this 510(k)." This means that the submission does not include a clinical study designed to prove the device meets specific performance criteria related to the effectiveness of promoting hair growth. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document in the context of device performance regarding its intended clinical effect.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical testing for safety and electrical/software compliance, not clinical efficacy.

However, I can provide information based on the other aspects of the document:

Based on the provided 510(k) Summary, the following information can be extracted:

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

As no clinical efficacy study was conducted for this 510(k), there are no clinical performance acceptance criteria and reported device performance related to hair growth in this document. The "acceptance criteria" mentioned are related to safety and functional compliance.

• ANSI/AAMI ES60601-1: 2005 & A1:2012 & A2:2021
• IEC 60601-1-11: 2015+AMD1:2020
• IEC 60601-2-57: 2023
• IEC 60601-1-2: 2014+AMD1:2020
• IEC 62471: 2006
• IEC 62133-2: 2017+AMD1:2021
• IEC 60601-1-6: 2010+AMD1:2013+AMD2:2020
• IEC 62366-1: 2015+AMD1:2020 |
  | Biocompatibility:
  (for PC+ABS shell, surface-skin contact,

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

Breo Laser Hair Growth Comb is a hand-held comb-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The device also has a massage function which is a mechanical vibration function.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Breo Laser Hair Growth Comb (Scalp 3L)". It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific acceptance criteria and performance metrics for a novel AI/medical device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them (especially those related to AI algorithm performance or direct clinical efficacy studies with specific metrics) are not present in the provided text. The document states "Clinical study: Not applicable" (Section 9), indicating that a clinical trial to prove efficacy or safety in the traditional sense was not required for this 510(k) clearance due to the device's similarity to an already cleared predicate.

Here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria here are implicitly met by demonstrating substantial equivalence to a predicate device (Laser Therapy Hair Growth Comb, Lasercomb-001, K230134). This means the device performs similarly in terms of its technical specifications and intended use.

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The PBM Hair Therapy Cap is indicated to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I to II, males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss, females and males with frontal patterns of hair-loss both with Fitzpatrick Skin Types I to IV.

The PBM Hair Therapy Cap is a hair therapy device that uses red light to help stimulate hair growth in both male and females. The device comes with a Cap that has LED diodes inbuilt and an attachable controller battery pack that comes with an automatic timer that limits the user to 15-minute sessions. The device uses only 660nm LED wavelength diodes on 7 strips, each strip has 12 diodes. These diodes strips are sewn into a cap and has a Type C USB connector that the controller battery pack can connect to. The PBM Hair Therapy Cap is comprised of a fabric cap with inbuilt LED diodes that emit red light on the wavelength of 660nm. The diodes are on strips and the cap style hat has 7 strips with 12 diodes on each strip with a total of 84 LED diodes. A battery powered controller that attaches via a C-type USB connector to the fabric hat is also provided. The controller has a built in 3.7V lithium-ion battery, has an on/off button and in programmed to automatically turn of after 15min of use. The controller also has a 2 small indicator LED's for indicating, power on/in use, needs charging and also blinks while in charging mode. The controller charges via inbuilt C-Type USB port and charges at 500 mA.

The provided documentation is a 510(k) premarket notification summary for the PBM Hair Therapy Cap. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo clinical study with specific acceptance criteria, and detailed performance metrics to prove direct efficacy of the new device.

Therefore, the information typically requested in your prompt regarding acceptance criteria, specific study design details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance, training set details), and statistical proof of meeting those criteria is not present in this type of FDA submission.

Instead, the document makes a comparison between the PBM Hair Therapy Cap and a predicate device (Revian Red) based on intended use, technological characteristics, and safety profiles.

Here's a breakdown of what can be extracted from the document in relation to your request, and what is explicitly stated as "Not Applicable" or absent:

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

This information is not provided in the document as it's a substantial equivalence submission, not a direct clinical efficacy study for the new device. The document asserts "substantially equivalent" rather than meeting pre-defined acceptance criteria for performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. As explained above, this is not a new clinical efficacy study.

3. 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)

This information is not provided.

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

This information is not provided.

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

There is no mention of an MRMC study. The device is a "Hair Therapy Cap" that uses light, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a physical light therapy cap, not an algorithm.

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

This information is not provided. The submission relies on demonstrating similarity to a previously cleared device.

8. The sample size for the training set

This information is not applicable as there is no mention of a "training set" in the context of an AI/ML algorithm for this device.

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

This information is not applicable.

Summary of available information related to equivalence:

• Predicate Device: Revian Red (K173729)
• Basis for Equivalence:
  • Intended Use/Indications for Use: The PBM Hair Therapy Cap is indicated to treat Androgenetic Alopecia and promote hair growth in females (Ludwig-Savin Scale I to II) and males (Norwood Hamilton Classifications of IIa to V), both with Fitzpatrick Skin Types I to IV. This is stated to be substantially equivalent to the predicate, "just worded slightly differently."
  • Technological Characteristics: Both devices utilize LLLT (Low-Level Laser Therapy) mechanism of action with textile hair growth on the scalp.
    • Similarities: Use 660nm LED wavelength.
    • Minor Differences (considered negligible and not affecting therapeutic value or safety):
      • Battery types (lithium polymer in predicate vs. 3.7V lithium-ion in PBM Hair Therapy Cap).
      • Wavelengths (both 660nm, but the statement implies the predicate might have a range while the PBM is specifically 660nm).
      • Number of Red LEDs (PBM: 84 diodes; Predicate: 119 Red LEDs).
      • Treatment durations (PBM: 15 minutes; Predicate: 10 minutes).
  • Safety Profile: Both devices are classified as class 3R laser systems in accordance with IEC standards and share a substantially equivalent adverse event profile.
• Non-Clinical Tests: "Verification of requirements (VR0001) and usability testing (US001, in accordance with IEC 62366-1:2015 and Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff)." These are generally about meeting engineering specifications and usability standards, not clinical efficacy trials.
• Conclusion: The totality of non-clinical data provides valid scientific evidence to support the conclusion that there are no different questions of safety and effectiveness raised when compared to the predicate device. This data demonstrates the PBM Hair Therapy Cap is substantially equivalent to the predicate Revian Red based upon the totality of the evidence.

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The Robin's Egg is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-I to I-4, II-I, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

The Telebrands' Robin's Egg is a non-invasive, helmet-style photobiomodulation device indicated to treat androgenetic alopecia in both men and women. It is operated using a single button at the front of the helmet to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment. The Robin's Egg is a system comprised of a wearable soft textile Cap using driver electronics, a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board containing 126 LEDs, as compared to 119 within the predicate device REVIAN RED. The Robin's Egg is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled by means of a single button and illuminated control display at the front of the helmet. Emitting red light energy within the 625 - 660 nm at 2.376 mW/cm² for a treatment time of 10 minutes, the Robin's Egg provides a well-established photobiomodulation effect upon the scalp to stimulate hair growth.

This document is not a study that proves the device (Robin's Egg) meets acceptance criteria for efficacy. Instead, it is a 510(k) Premarket Notification from the FDA, confirming that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device (REVIAN RED K173729) for its stated indications for use.

Crucially, no clinical trial data for the Robin's Egg was submitted for this 510(k). The clearance is based on the substantial equivalence of the device's technical characteristics and non-clinical performance to the predicate device. Therefore, a direct study proving the Robin's Egg meets specific efficacy acceptance criteria, as one might find in a clinical trial report, is not present here.

Given the information provided, I cannot fill out the requested table for "acceptance criteria and the reported device performance" as it pertains to efficacy, nor can I provide details on sample sizes, expert ground truth establishment, or MRMC studies for this specific device's efficacy. The regulatory review focused on equivalence, not a new demonstration of efficacy.

However, I can extract information regarding the basis for regulatory clearance and what non-clinical testing was performed:

Summary of Information from the 510(k) Document:

1. Table of (Non-Clinical) Acceptance Criteria and Reported Device Performance:

Since no clinical efficacy data for the Robin's Egg was submitted, the "acceptance criteria" here refer to non-clinical performance and substantial equivalence to the predicate.

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

• For clinical efficacy: No test set (clinical data) was used or submitted for the Robin's Egg as part of this 510(k). The clearance is based on substantial equivalence to a predicate device, not on new clinical efficacy data for the Robin's Egg itself.
• For non-clinical testing (Electrical, EMC, Biocompatibility, etc.): The sample sizes for these engineering and lab tests are not specified in the document. The data provenance would be internal laboratory testing conducted by or for Telebrands Corporation. The FDA letter is dated September 17, 2024, and the submission was received on August 16, 2024.

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

• For clinical efficacy: Not applicable, as no clinical efficacy test set for the Robin's Egg was submitted.
• For non-clinical testing: The document does not specify the number or qualifications of experts involved in establishing "ground truth" for the non-clinical tests (e.g., electrical safety, EMC). These tests typically rely on standardized methods and equipment calibration rather than expert consensus on a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set:

• Not applicable, as no clinical efficacy test set for the Robin's Egg was submitted.

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

• No, a MRMC comparative effectiveness study was not done or submitted for the Robin's Egg. This type of study is typically used to demonstrate the impact of AI algorithms on human reader performance, which is not relevant for this device's type of regulatory submission (substantial equivalence for a physical light therapy device).

6. Standalone (Algorithm Only) Performance Study:

• No, this is not applicable. The Robin's Egg is a physical light therapy device, not an AI algorithm.

7. Type of Ground Truth Used:

• For clinical efficacy: Not applicable, as no clinical efficacy data for the Robin's Egg was submitted.
• For non-clinical testing: The "ground truth" was based on adherence to recognized national and international standards (e.g., IEC, ANSI/AAMI, ISO) for electrical safety, electromagnetic compatibility, biocompatibility, photobiological safety, and human factors. This is a technical ground truth based on compliance with established engineering and safety testing protocols.

8. Sample Size for the Training Set:

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

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

• Not applicable.

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