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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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The subject F65 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:

The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for:

• o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles)
• o Cutaneous lesions, including warts, scars and striae
• o Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
• o Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
• o Mild to moderate inflammatory Acne (Acne vulgaris)

The Nd: YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd: YAG) is indicated for:

• o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
• o The removal of unwanted hair and to effect table long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
• o The non-ablative treatment of facial wrinkles

The F65 module and handpiece, with wavelength of 1565 nm, are indicated for:

• o Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue
• o Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.

The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for:
o Removal of dark tattoos
o Treatment of pigmented lesions

*Note
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.

The Lumenis Be F65 Laser System is intended to be used for the new indication for Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV seeking treatment for hair loss, as well as, for the identical set of functions as the predicate device. The description here is limited to the system module required to support the new indication which is the subject of this 510(k):

• The laser console includes a power supply unit, a Laser module (+ aiming beam), a control unit and a PC module. The laser beam is transferred to the handpiece via fiber optics.
• . The handpiece includes a scanner module – built of two mirrors that are controlled by two motors directing the Laser beam to desired target tissue.
• . The handpiece uses a tip (user may choose from two types) to align the Laser beam focus with the target tissue, enabling a treatment shape size and a tip thermo-electric cooler (TEC).

The F65 is intended for professional use only.

The provided FDA 510(k) summary only describes the clinical studies for the F65 module and handpiece with 1565 nm wavelength, specifically for the new indication of "Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss." It does not provide detailed acceptance criteria and performance data for all the device's indications, nor does it present the information in a clear table format for acceptance criteria vs. device performance.

Based on the information provided for the 1565nm module and its new indication:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new indication ("Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss") are implicitly derived from the study results presented in the document. The document states a primary efficacy endpoint of "demonstrating improvement in more than 70% of subjects" for the retrospective study.

2. Sample Sizes and Data Provenance

• Preclinical Study (Animal Testing): Sample size for the preclinical study is not specified, only that it "was conducted to evaluate the Lumenis F65 subject module for hair follicle regeneration capabilities using both Low Level Laser Therapy (LLLT) and untreated controls."
• Clinical Studies:
  • Prospective, Single Arm Study:
    • Sample Size: 32 subjects enrolled, 25 completed.
    • Diagnosis Breakdown: 18 with Androgenic Alopecia, 7 with other diagnoses (evaluated separately).
    • Hair Count Data: 5 male subjects with androgenic alopecia, 18 female subjects with androgenic alopecia.
    • Data Provenance: Not explicitly stated, but clinical studies are generally prospective. No country of origin is mentioned.
  • Retrospective, Single Arm Study:
    • Sample Size: 98 subjects evaluated for performance.
    • Diagnosis Breakdown: 44 with confirmed Androgenic Alopecia, 54 with no documented diagnosis (presumably hair loss but not specifically diagnosed as androgenic alopecia).
    • Data Provenance: Retrospective. No country of origin is mentioned.

3. Number of Experts and Qualifications for Ground Truth

• Retrospective Study: "a group of 3 blinded reviewers" were used for the assessment of improvement in scalp hair appearance.
• Qualifications of Experts: The specific qualifications (e.g., dermatologist, years of experience) of these 3 blinded reviewers are not specified in the provided document. They are only referred to as "reviewers."

4. Adjudication Method for the Test Set

• For the retrospective study, where 3 blinded reviewers assessed improvement, the adjudication method is not explicitly stated. It's mentioned they "yielded a correct identification" in a certain percentage of cases. This implies either:
  • All 3 reviewers had to agree (unlikely for such high percentages given typical inter-reader variability without prior agreement).
  • A majority vote (2 out of 3) was used.
  • One expert's assessment was deemed primary, or they collectively discussed and reached a consensus.
    The document does not detail the process.

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

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done comparing human readers with AI assistance vs. without AI assistance.
• The studies described are for the device's direct effect on hair growth, not for evaluating human reader performance with or without an AI. The "blinded reviewers" in the retrospective study were assessing the clinical outcome (improvement in scalp hair appearance), not the performance of an AI algorithm.

6. Standalone (Algorithm Only) Performance

• This document describes a medical device (laser system) that directly treats patients, not an AI algorithm. Therefore, there was no standalone (algorithm only) performance study as it's not an AI device. The "performance" refers to the clinical outcome achieved by the laser system.

7. Type of Ground Truth Used

• For the clinical studies, particularly the retrospective study, the "ground truth" for showing improvement in scalp hair appearance was established by expert consensus/review (3 blinded reviewers).
• For the prospective study, quantifiable metrics like mean increase in hair count per cm² from baseline were reported, which can be considered objective outcomes data.

8. Sample Size for the Training Set

• This document describes physical medical device studies (laser system) for a 510(k) submission, not an AI model requiring a training set. Therefore, there is no concept of a "training set" in the context of this submission. The "training" here refers to the device's design and manufacturing through engineering principles and prior knowledge, not machine learning.

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

• As there is no AI model or "training set" in the context of this device submission, this question is not applicable.

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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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