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The Bosley Booster 128 Laser Cap, Boster 162 Laser Cap, and Bosley Booster 288 Laser Cap are indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.

The Bosley Booster Family of Laser Caps are low-level laser therapy (LLLT) devices designed to promote hair growth in women and men by exposing the entire scalp to the photo-stimulation of visible, red laser diodes and LEDs at 650-nm and 5mW each. The lasers and diodes are contained inside a lightweight cap. The device is powered by an included battery pack and automatically turns off after 30 minutes. The Boster Family of Laser Caps are identical to the cleared Bosley Revitalizer 272, 164 and 96 Laser Caps with the exception of the number of included low level laser diodes (LDs) and LEDs as shown below:

1. Configuration of Models

The provided text is a 510(k) premarket notification for a medical device (Bosley Booster Laser Caps) and does not describe a study involving acceptance criteria and device performance in the context of an AI/ML algorithm.

Instead, the document focuses on demonstrating that the new devices are substantially equivalent to previously cleared predicate devices, primarily by comparing their technological characteristics and safety profiles. The key points are:

• No AI/ML Algorithm: The devices described are Low-Level Laser Therapy (LLLT) devices that use red light laser diodes and LEDs to stimulate hair growth. There is no mention of any AI or machine learning component in their design or function.
• Substantial Equivalence: The primary goal of this submission is to show that the Bosley Booster Laser Caps are substantially equivalent to existing cleared devices (Bosley Revitalizer Laser Caps and other reference devices). This means showing that the new devices are as safe and effective as the predicate devices, with no new questions of safety or effectiveness raised.
• Performance Data for Device Hardware: The "Performance Data" section refers to verification and validation activities conducted on the hardware (e.g., output of each laser diode, operation of safety interface, power pack output) to confirm compliance with design specifications and recognized standards (e.g., IEC-60601-1, IEC-60601-2-22).
• Risk Analysis (FMEA): A Failure Modes and Effects Analysis (FMEA) was used to identify and assess risks, concluding that the reduced number of laser diodes and LEDs in the new models does not introduce new unacceptable risks.
• No Clinical Efficacy Study Mentioned for This Submission: While the devices are indicated to promote hair growth, the document does not present a new clinical study to establish the efficacy of the Bosley Booster Laser Caps. Instead, it relies on the established efficacy of the predicate devices, arguing that the minor variations in laser/LED count will only affect the time required to achieve the same results, not the fundamental efficacy or safety. The slight variations in total "dose" (delivered energy over time) are noted.
• No Ground Truth for AI/ML: Since there's no AI/ML component, there's no discussion of ground truth, training sets, test sets, or expert adjudication in that context.

Therefore, I cannot provide the requested table and study information related to acceptance criteria for an AI/ML device, as the provided text pertains to a hardware device without AI/ML characteristics.

If you can provide a document that discusses an AI/ML device in the context of a clinical study for regulatory submission, I would be able to answer your request.

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The ID-510 iRestore Elite is indicated to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.

The ID-510 iRestore Elite is a low-level laser/light system operating at 680 ± 10, 655 ± 10, and 625± 10 nanometers. The physical configuration is that of a helmet containing an inner and outer liner, stabilized with a silicone pad lined fixation ring. The device helmet is constructed of an ABS type plastic. The system operates on line voltage at 100 or 240 volts. The helmet's inner liner permits full adjustment to any heads of non-toxic silicone pads. The helmet contains 300 units of five-millwatt-diode lasers and 200 units of fivemilliwatt, super luminescent diodes, that emit red light. This system delivers fixed laser emission levels, measured to be 2500 total millwatts per 12 minute treatment session, which cannot be altered by the operator.

The provided text describes a 510(k) premarket notification for the ID-510 iRestore Elite device, which is an infrared lamp for promoting hair growth. The document focuses on demonstrating substantial equivalence to a predicate device (ID-500 iRestore Hair Growth System) rather than providing specific acceptance criteria and detailed study results for the ID-510 iRestore Elite itself.

The document lists non-clinical performance data (e.g., cytotoxicity, electrical safety, software verification) that were performed to support substantial equivalence. However, it does not detail a clinical study with acceptance criteria for device performance based on hair growth outcomes in human subjects, nor does it refer to an AI algorithm that would typically have the detailed study requirements you've requested.

Therefore, I cannot provide the information you asked for regarding:

• A table of acceptance criteria and reported device performance related to hair growth.
• Sample size used for a test set, data provenance, or expert involvement for ground truth, as these typically relate to the validation of a diagnostic or AI-driven device's performance.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth on a test set.
• MRMC comparative effectiveness study results or effect sizes for human readers with/without AI assistance.
• Standalone (algorithm-only) performance.
• Detailed type of ground truth beyond the general claim of "safety and effectiveness" through non-clinical tests.
• Sample size for the training set or how ground truth for a training set was established, as this implies a machine learning model, which is not described.

The information provided solely pertains to the non-clinical tests performed to demonstrate the ID-510 iRestore Elite's safety and effectiveness for substantial equivalence, not its direct clinical efficacy against quantified hair growth metrics under specific acceptance criteria.

The document states:

• "To demonstrate safety and effectiveness of ID-510 iRestore Elite and to show substantial equivalence to the predicate device, Remax Medi-Tech (Shenzhen) Corporation completed the following non-clinical tests."
• "Results confirm that the design inputs and performance specifications for the device are met."
• "The ID-510 iRestore Elite passed the testing in accordance with internal requirements, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:"

The tests listed are:

• Cytotoxicity testing per ISO 10993-5: Passed
• Sensitization testing per ISO 10993-10: Passed
• Electrical safety testing per ANSI AMMI 60601-1: Passed
• Electromagnetic Disturbance (EMC) testing per IEC 60601-1-2: Passed
• Software verification and validation per FDA Guidance: Compliant
• Lifetime Testing: Supports lifetime of five years
• Transportation Testing per ASTM D4169: Demonstrates package integrity maintained

This means the acceptance criteria detailed are for these non-clinical engineering and biocompatibility tests, not for a clinical outcome like hair growth percentage or density, and there is no mention of an AI component requiring a "test set" or "training set" in the context of machine learning.

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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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