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The HairMax Laser 272, 202 and 80 are indicated to promote hair growth in males with androgentic alopecia who have Norwood-Hamilton Classifications of IIa - V, or females with androgenetic alopecia who have Ludwig-Savin Classifications I - II or Frontal and for both with Fitzpatrick Skin Phototypes I- IV.

The HairMax Laser 272, 202 or 80 each contain the listed number of 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 HairMax Laser 272, 202 and 80 are powered by a lithium-ion battery pack that contains an embedded controller chip. In all other area of design, manufacturing, and aesthetic appearance, the devices are identical.

This FDA 510(k) summary for the HairMax Laser Models 272, 202, and 80 explicitly states that no clinical performance data was produced for this submission. The device's substantial equivalence is based on its identical technological characteristics and treatment regimen to already cleared predicate devices.

Therefore, the request for a table of acceptance criteria and reported device performance isn't applicable in the traditional sense of a study validating performance against specific criteria, as no such study was conducted for this submission. Similarly, information regarding sample sizes, ground truth establishment, expert adjudication, or MRMC studies is not available in this document.

However, the document does describe an Over-The-Counter Testing Program to assess user comprehension and the suitability for OTC sale. I will detail that study.

Over-The-Counter Testing Program

1. Table of Acceptance Criteria and Reported Device Performance (for OTC Suitability):

• Correct Self Selection (decision to purchase product or not based on Intended Use)
• Correctly assemble and use the product
• Comprehend hazards and maintenance procedures | 90% pass rate |

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

• Sample Size for Test Set: 40 volunteer subjects
• Data Provenance: Not specified, but implied to be a prospective study conducted for this submission, likely within the United States where the FDA submission is made.

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

• Not applicable. The ground truth for this study was the subjects' ability to correctly understand and interpret the product information (packaging and manual) without assistance. The "ground truth" was essentially the objective correct answers to the 26 questions. No external experts were used to establish this ground truth.

4. Adjudication Method for the Test Set:

• Single interviewer. Subjects were given a "P" (PASS) if all questions were answered correctly, and an "F" (FAIL) if any questions were answered incorrectly. No further adjudication among interviewers or experts is mentioned.

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

• No, a MRMC comparative effectiveness study was not done. This study was focused on user comprehension for Over-The-Counter suitability, not clinical efficacy or diagnostic accuracy.

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

• This is not applicable as the device is a laser therapy product, not an AI algorithm. The OTC study assessed human comprehension of product information.

7. The Type of Ground Truth Used:

• The ground truth was established by the objective correct answers to the 26 questions derived directly from the product's standard retail package and full owner's manual.

8. The Sample Size for the Training Set:

• Not applicable. This study was a single test set for OTC suitability, not a machine learning study requiring separate training and testing sets.

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

• Not applicable (see point 8).

Summary regarding Clinical Performance:

It is crucial to reiterate that no clinical performance data was produced for this submission (K180885) to prove the device meets acceptance criteria for hair growth promotion. The substantial equivalence relies on the fact that the HairMax Laser 272, 202, and 80 are considered identical devices (private label, same manufacturer, same parts, same treatment regimen) to devices that were previously cleared by the FDA and presumably had clinical data submitted in their respective 510(k)s (K173678, K163170, K161875). Therefore, the clinical acceptance criteria and the studies proving them would be found in the documentation for those predicate devices, not in this specific 510(k) submission.

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The HairMax LaserComb 41 is indicated to treat Androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.

The HairMax LaserComb 82 is indicated to treat Androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.

The HairMax LaserComb 41 (HMLC 41) and HairMax LaserComb 82 (HMLC 82) are low-level laser devices that provide distributed laser light to the scalp while comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The HMLC 82 device emits 82 laser beams with wavelengths of 655 nm (+/- 10 nm), spaced at 7mm intervals and has a total laser module output within the limitation of a Class 3R laser. The HMLC 41 device emits 41 laser beams with wavelengths of 655 mm (+/- 10 nm), spaced at 7mm intervals and has a total laser module output within the limitation of a Class 3R laser. The laser diode modules used in the HMLC 41 & 82 are identical to those used in their predicate devices.

As with the predicate device, the HMLC 41 & 82's lasers are contained in between hair parting teeth that push the hair aside, allowing the optimum amount of laser energy to reach the scalp, as the user passes over the scalp. The hair parting teeth move the hair aside and allow an unobstructed path of laser energy to the scalp.

At the beginning of a treatment session, the device is placed in the first position on the scalp (the first 7.5cm scalp section, closest to the forehead) and will rest here for the intended treatment time. As with the predicate devices, the HMLC 41 & 82 will use a short vibration to advise the user it is time to move to the next scalp location. The HMLC 41 & 82 will maintain contact with the scalp allowing the hair parting teeth to part the hair as the user moves the device backwards, combing the hair, along the scalp to the second position. The teeth are necessary to part the hair and provide an unobstructed path for the laser light to reach the scalp. The device will remain in the second position until the vibration informs the user to move to the third position. Similar indication and movement will continue for three positions to cover the entire area of hair loss on the scalp. The lasers will automatically turn off after the intended treatment duration.

The units operate from an internal, rechargeable lithium polymer battery. The LiPoly battery is charged from a Class 2, UL, and CUL rated wall transformer at 6VDC and 1000mA. In the event of a power failure, the laser control circuitry is designed to disable the laser diodes until reactivated by the control switch. The devices include battery monitoring and charging circuitry which ensure the effective delivery of optimal laser energy output during the treatment time. The devices include a proximity sensor and will not allow the lasers to be turned on unless in contact with the scalp.

The provided text describes the HairMax LaserComb 41 and HairMax LaserComb 82 devices and their substantial equivalence to previously cleared predicate devices (HairMax LaserComb Lux 9, K110233 and K103368). The submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials for safety and effectiveness from scratch. Therefore, the information provided focuses on demonstrating that the new devices are as safe and effective as the predicate.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" for a new study are not presented in the typical sense of a clinical trial with primary and secondary endpoints. Instead, the performance is evaluated against the predicate device’s established safety and efficacy. The criteria primarily relate to maintaining the same technological characteristics and output as the predicate.

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

The provided document describes bench testing to demonstrate performance and safety. It does not mention a clinical "test set" in the sense of human subjects with a specified sample size. The "data provenance" is from laboratory measurements and comparisons to the predicate device's established characteristics. There is no indication of country of origin for a clinical data set or whether it’s retrospective or prospective, as no new clinical study (involving human subjects) is described for this submission.

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

Not applicable for this submission. The ground truth for proving substantial equivalence here relies on bench test measurements against engineering specifications and comparison to a predicate device, rather than expert clinical consensus on a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no human-adjudicated "test set" in the context of this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned. This submission focuses on demonstrating substantial equivalence through technological comparison and bench testing, not through new clinical trials with human readers.

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

This device is not an algorithm; it is a physical medical device. Therefore, a standalone algorithm performance study is not applicable. The device's "standalone" performance relates to its physical operation and outputs as measured in bench testing.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

• Bench test measurements: Laser output parameters, dose rate, electrical characteristics.
• Engineering specifications: Conformance to IEC60825-1:2007 for laser safety, and internal product specifications for laser modules (wavelength, divergence, power levels).
• Regulatory precedent: The safety and effectiveness data of the legally marketed predicate devices (HairMax LaserComb Lux 9, K110233 and K103368) forms the foundational "ground truth" that the new devices are compared against for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This document describes a 510(k) submission based on substantial equivalence, not the development of a machine learning algorithm that requires a "training set."

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

Not applicable, as there is no "training set" in this context.

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The HairMax LaserComb Advanced 7 is indicated to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I to IV.

The HairMax LaserComb Pro 12 is indicated to treat Androgenetic Alopecia and promote hair growth in females with who have Ludwig-Savin Scale 1-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I to IV.

Similar to the HairMax Lux 9 K110233, the modified HairMax Advanced 7 and Pro 12 consist of a hand-held low level laser device that emits laser light with the intention to promote hair growth. 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 provided text describes modifications to an existing device (HairMax Lux 9) and seeks substantial equivalence for the new devices (HairMax Advanced 7 and Pro 12). Therefore, it primarily focuses on comparing the new devices to the predicate rather than presenting a standalone study with acceptance criteria and performance metrics for the new devices based on a clinical trial.

However, based on the nonclinical testing section, we can infer that the acceptance criteria for the HairMax Advanced 7 and Pro 12 were primarily related to their compliance with design specifications and operational functionality, as they are considered substantially equivalent to the previously cleared HairMax Lux 9. The study proving this involved performance testing to confirm compliance to design specifications; all functions were verified to operate as designed.

Here's a breakdown of the information that can be extracted or reasonably inferred from the provided text, while also noting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not mentioned. The testing described is "nonclinical testing" related to design specifications and functionality, not a clinical trial on human subjects.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned. Given it's nonclinical testing, this information would likely refer to laboratory or manufacturing test data, not patient data.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Adjudication Method: Not mentioned. This type of method is typically associated with expert review of clinical data, which is not described here for the "test set" in question (which refers to nonclinical performance).

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a low-level laser device for hair growth, not an AI-assisted diagnostic or imaging device.

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

• Standalone Performance: Not applicable. This device is a hardware device (laser comb), not an algorithm or software. Its performance is inherent in its physical operation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: For the nonclinical testing described, the "ground truth" would be the design specifications and operational requirements of the device. The testing verified that the devices operated as designed and met these predefined technical criteria. The "ground truth" for the intended use (promoting hair growth) would have been established by studies on the predicate device (HairMax Lux 9), which is not detailed in this document.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that uses training sets.

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

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

Summary of what the document indicates for the new devices:

The document primarily focuses on demonstrating that the HairMax Advanced 7 and Pro 12 are substantially equivalent to the predicate device, HairMax Lux 9 (cleared under K110233). This substantial equivalence is based on:

• Identical intended use and indications for use.
• Identical core technological characteristics (same laser modules, hair parting teeth, operating principle, basic design, physical properties, materials, laser power, wavelength, delivery method, instructions for use, audible timer).
• The only difference being the quantity of laser modules, with treatment time adjusted to compensate.
• Nonclinical testing confirmed the new devices complied with design specifications and operated as designed, and that these modifications did not alter device safety.

The explicit detailed acceptance criteria and a human-results clinical study are not provided for the new devices in this document, as the submission relies on the established safety and efficacy of the predicate device.

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The HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 are indicated to treat androgenetic alopecia, promote hair growth and help prevent further hair loss in males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss and Fitzpatrick Skin Types I to IV.

Substantially equivalent to the HairMax LaserComb (K060305, K093499), the modified HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 are handheld low level laser devices that emits laser light with the intention to promote hair growth. The devices provide 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. HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 replace the cleared version's single beam laser and beam splitting reflector with a circuit board containing seven, nine, or twelve laser diodes. respectively.

The provided text describes clinical trials for the HairMax LaserComb devices, but it does not contain the level of detail typically found in a study proving a device meets specific acceptance criteria, especially for an AI/CADe device. The information is geared towards establishing substantial equivalence to previously cleared devices.

However, I will extract the information that is present and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for a new device's performance metrics (e.g., specific sensitivity, specificity, or accuracy thresholds). Instead, it focuses on demonstrating substantial equivalence to predicate devices in terms of safety and effectiveness. The reported performance relates to the effect of the device rather than specific diagnostic or analytical metrics.

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

The document mentions "Two randomized, double-blind, controlled, multi-center clinical trials" were conducted.

• Test Set Sample Size: The exact sample size for these clinical trials is not provided in the given text.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: "randomized, double-blind, controlled, multi-center clinical trials" are inherently prospective studies.

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

This information is not provided in the given text. The studies evaluated changes in "terminal hair-count in the evaluation zone," which implies objective measurement rather than expert consensus on a diagnostic image.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with vs. without AI assistance was not done, nor would it be relevant for this type of device. The HairMax LaserComb is a therapeutic device, not an AI/CADe diagnostic tool that assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The HairMax LaserComb is a physical therapeutic device, not an algorithm. Its performance is assessed as a standalone device used by a human, but there is no "algorithm only" performance to evaluate in this context. The clinical trials evaluated the device's effect on hair growth in patients.

7. The Type of Ground Truth Used

The ground truth used in the clinical trials was likely based on objective measurements of hair growth (e.g., changes in terminal hair count, possibly photographic assessment, or other standardized dermatological metrics to assess hair density and growth). The document mentions "evaluating changes in terminal hair-count in the evaluation zone." This falls under outcomes data or objective clinical measurements.

8. The Sample Size for the Training Set

This question is not applicable in the context of the provided text. The HairMax LaserComb is a physical medical device, not an AI/ML algorithm that requires a "training set." The clinical trials served as the verification and validation studies for the device's performance.

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

This question is not applicable, as there is no "training set" for this type of device.

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The HairMax LaserComb is indicated to promote hair growth in males, 30-60 years of age with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and Fitzpatrick Skin Types I to IV.

Similar to the HairMax LaserComb K060305, the modified HairMax LaserComb consists of a hand-held low level laser device that emits laser light with the intention to promote hair growth. 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 predicate unit operates from solely on a class 2, UL and CUL rated wall transformer. The modified unit adds a Lithium ion battery power supply option. In addition, cosmetic changes are being made to the device color and exterior plastic housing. Changes do not alter form fit or function as compared to the predicate device.

Here's an analysis of the provided 510(k) summary, specifically addressing the acceptance criteria and study information:

The document (K093499) describes a modified HairMax LaserComb (version 5.2) and seeks substantial equivalence to a previously cleared device (K060305). Crucially, this 510(k) pertains to modifications (adding a Li-ion battery, cosmetic changes) to an already cleared device, not a new device requiring a full de novo clinical study to prove efficacy. The submission explicitly states that the changes "do not alter form fit or function as compared to the predicate device" and "do not affect the safety or performance of the device and do not change the intended use of the HairMax LaserComb."

Therefore, the document does not contain information about a clinical study proving the modified device's performance against acceptance criteria in terms of hair growth promotion. Instead, it relies on the predicate device's existing clearance and demonstrates that the modifications do not negatively impact safety or effectiveness.

Based on the provided text, the following information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this 510(k) is for a modified device and not a new device requiring efficacy trials for hair growth, there are no specific performance acceptance criteria for hair growth or reported device performance for this particular submission. The focus is on demonstrating that the modifications do not affect safety or performance compared to the predicate.

The document mentions: "Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied for each are listed in Section 10." However, Section 10 is not included in the provided text. These tests would typically be related to electrical safety, mechanical integrity, battery performance, and electromagnetic compatibility to ensure the modified device is as safe as the predicate, rather than clinical efficacy.

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

• Sample Size: Not applicable for a hair growth efficacy study in this submission. The document refers to "verification and validation tests" in Section 10, which would have their own sample sizes for engineering/safety tests, but these are not specified.
• Data Provenance: Not applicable for a hair growth efficacy study in this submission.

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

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, 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 low-level laser therapy device for hair growth, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used:

• Not applicable for hair growth efficacy in this submission. For the safety and performance of the modified device, the "ground truth" would be compliance with internal design specifications and relevant industry standards (e.g., electrical safety standards).

8. The sample size for the training set:

• Not applicable. No AI/machine learning model is being trained here.

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

• Not applicable. No AI/machine learning model is being trained here.

Summary of what the document does provide regarding acceptance/equivalence:

• Predicate Device: HairMax LaserComb K060305. The current device (K093499) is considered substantially equivalent to this predicate.
• Basis for Equivalence:
  • Same indicated use: "to promote hair growth in males, 30-60 years of age with androgenetic alopecia who have Norwood Hamilton Classifications IIa -V patterns of hair loss and Fitzpatrick Skin Types I to IV."
  • Same operating principle.
  • Same basic device design and physical properties.
  • Same materials.
  • Same technological characteristics (laser power, wavelength, laser delivery method, comb component, instructions for use, audible timer).
• Modifications: Adding a Lithium ion battery power supply option and cosmetic changes (device color and exterior plastic housing dimensions).
• Verification of Modifications: The submission states these modifications "do not alter form fit or function as compared to the predicate device" and "do not affect the safety or performance of the device and do not change the intended use." Performance testing was conducted "to confirm compliance to design specifications; all functions were verified to operate as designed." (Details of these tests and their acceptance criteria are in a section not provided).

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The LaserComb is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV.

The LaserComb consists of a hand-held low level laser device that promotes hair growth. 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. When in use, the device emits a beep every four seconds to notify the user to move the device to a new section of the scalp.

Here's a breakdown of the acceptance criteria and the study details for the Lexington International, LLC LaserComb, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the clinical study's findings regarding the device's ability to promote hair growth and its safety profile.

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

• Sample Size for Test Set: Not explicitly stated as a single number. The document refers to "subjects" in a multicenter clinical trial. To provide a precise number, further details from the full clinical study report would be needed. However, it was a "multicenter" trial, indicating a reasonable sample size across multiple locations.
• Data Provenance:
  • Country of Origin: United States ("conducted at four sites in the United States").
  • Retrospective or Prospective: Prospective (clinical trial where subjects were enrolled and followed over time).

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

The document does not mention the use of experts to establish ground truth for the test set in the context of image analysis or diagnostic interpretation. The ground truth for efficacy was objectively measured (mean terminal hair density) and subjectively assessed by the subjects themselves (overall hair regrowth). For safety, adverse events were monitored.

4. Adjudication Method for the Test Set

Not applicable. The study design was a randomized, placebo-controlled trial. Efficacy endpoints were objective measurements (hair density) and subjective assessments by the subjects, not requiring expert adjudication of "ground truth" in the diagnostic sense. Safety endpoints involved adverse event reporting.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves multiple human readers evaluating cases with and without AI assistance to measure improvement in diagnostic performance. The LaserComb study focused on the direct physiological effect (hair growth) of the device versus a placebo, not on assisting human interpretation.

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

Yes, a standalone study was done. The clinical trial evaluated the LaserComb device itself (algorithm/device only) in the treatment group compared to a sham device (placebo group). There was no "human-in-the-loop" component where the device was assisting a human operator in making a decision. The device directly delivers the therapeutic intervention.

7. Type of Ground Truth Used

The ground truth used for efficacy was:

• Objective Measurement: Mean terminal hair density. This is a direct, quantifiable biological change.
• Subjective Assessment: Subjects' self-assessment of overall hair regrowth.
  For safety, the ground truth was based on reported adverse events.

8. Sample Size for the Training Set

Not applicable/not provided. This device is a therapeutic device, not an AI algorithm that requires a separate "training set" for model development. The clinical study serves as the primary validation of its efficacy and safety.

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

Not applicable, as there is no "training set" in the context of an AI algorithm developer. The device's mechanism is based on low-level laser therapy, and its performance (efficacy and safety) was established through the described clinical trial.

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