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The Q-Renew LLLT Hair Growth Helmet is indicated for the promotion of 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 Q-Renew LLLT Hair Growth Helmet is a non-invasive, at-home low-level laser/light therapy (LLLT) device designed to promote hair growth in both men and women. It uses a dual light system that combines laser diodes (wavelength 655nm) with LEDs (wavelengths 630nm, 660nm, and 680nm) to deliver optimal light absorption by the scalp.

The device consists of a Q-Renew LLLT helmet, a charging base and a USB-C charging cable.

The helmet features an adjustable fit, controlled by a rear adjustment wheel, and an intuitive LCD screen for operation. Users can:

• Start or pause treatments
• Select treatment zones
• Check battery status
• View remaining session time

The helmet has a power button for turning the device on/off. The device also includes smart sensors—removing the helmet automatically pauses the session, while repositioning it resumes treatment. Each session lasts 12 minutes, after which the device stop the treatment automatically.

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

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

The System includes NEU180 and NEU300 two models.

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

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

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

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

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

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

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

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

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