Laser Hair Growth Cap by Shang Fa Biotechnology Co.

Laser Hair Growth Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.

Device Description

Laser Hair Growth Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 280, 272, 147, and 80 laser diodes at 650nm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included battery pack.

AI/ML Overview

The provided text describes the regulatory clearance (K192627) for a medical device called "Laser Hair Growth Cap." This document is a 510(k) Summary, which outlines how the device demonstrates substantial equivalence to previously cleared predicate devices. It focuses heavily on non-clinical testing and comparison of technical specifications rather than extensive clinical studies or AI performance metrics.

Based on the provided text, the device in question (Laser Hair Growth Cap) is a Low Level Laser Therapy (LLLT) device intended to promote hair growth. The document emphasizes substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study involving AI or human reader performance.

Therefore, many of the requested items (acceptance criteria for AI performance, sample sizes for AI test sets, number of experts for ground truth, MRMC studies, standalone AI performance, etc.) are not applicable to this document as it pertains to a physical medical device and its substantial equivalence to other physical devices, not an AI/ML algorithm or its associated performance studies.

Here's how to address the request based on the provided document:

A table of acceptance criteria and the reported device performance:
The document does not present "acceptance criteria" in the traditional sense of performance metrics for an AI/ML device (e.g., sensitivity, specificity, accuracy). Instead, it demonstrates substantial equivalence by comparing technical specifications and safety/performance test results against established standards. The "performance" reported is compliance with these standards and similar specifications to predicate devices.

Acceptance Criterion (Compliance)	Reported Device Performance
Intended Use Equivalence	Matches predicate devices for promoting hair growth in specific alopecia classifications and Fitzpatrick skin types.
Type of Use (OTC) Equivalence	Matches predicate devices.
Type of Light (LLLT, Laser Diodes) Equivalence	Matches predicate devices.
Wavelength (650 nm) Equivalence	Matches predicate devices.
Energy per laser diode (5mW) Equivalence	Matches predicate devices.
Laser Classification (Class 3R) Compliance	Complied with IEC 60825-1:2014, same as predicates.
Treatment time (30 min, 3x/week) Equivalence	Matches predicate devices.
Applicable People/Skin Equivalence	Matches predicate devices (Norwood-Hamilton IIa-V / Ludwig-Savin I-II, Fitzpatrick I-IV).
Design (Cap) Equivalence	Matches predicate devices.
Safety Standards (IEC 60601-1, -11, -2, IEC 62133, IEC 60950-1) Compliance	Complied with all listed standards.
Biocompatibility (ISO 10993-5, -10) Compliance	Complied with listed standards.
Shelf life	Tested (results not detailed but implied to be acceptable for clearance).
Software validation	Tested (results not detailed but implied to be acceptable for clearance).
Usability (IEC 60601-1-6, IEC 62366-1) Complianc	Complied with listed standards.
Conclusion of Substantial Equivalence	Device found substantially equivalent to predicate devices based on non-clinical testing and comparison.

Sample sizes used for the test set and the data provenance:
The document focuses on non-clinical (engineering, safety, performance, biocompatibility) testing of the physical device, not an AI/ML test set. Therefore, there's no "sample size" of a data set in the AI/ML context. The tests were performed on the device prototypes/production samples.
- Data Provenance: Not applicable in the AI/ML sense. The testing was conducted on samples of the physical device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for this device's clearance pertains to compliance with engineering standards (e.g., laser power output, electrical safety, biocompatibility standards, usability standards) rather than clinical ground truth established by experts interpreting medical images/data. The "experts" involved would be engineers and safety/quality assurance professionals verifying compliance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no test set requiring adjudication in the context of AI/ML ground truth establishment.
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 a physical device (Laser Hair Growth Cap), not an AI-assisted diagnostic or interpretive tool. No MRMC study involving human readers or AI assistance was conducted or mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm; it is a physical laser device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this regulatory submission is compliance with established international and national standards for medical devices, particularly for laser safety, electrical safety, biocompatibility, and general device performance. This is verified through laboratory testing and engineering analysis rather than clinical outcomes or expert consensus for diagnosis. The "intended use" (promoting hair growth) is aligned with the predicate device's intended use which was previously established.
The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
Not applicable. As there is no AI/ML component, there is no training set or a process for establishing its ground truth.

In summary: The provided FDA 510(k) summary (K192627) is for a physical medical device (Laser Hair Growth Cap) that uses Low Level Laser Therapy. The clearance is based on demonstrating substantial equivalence to existing predicate devices through non-clinical testing for safety, performance, and compliance with recognized standards. This document does not describe the evaluation of an Artificial Intelligence/Machine Learning (AI/ML) algorithm, and therefore, many of the questions related to AI/ML study design and performance criteria are not relevant to this specific submission.

Summary

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.