(90 days)
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
The IPL Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology to perform hair removal. The device mainly consists of IPL main body and power adapter two parts and it is only powered by the external power adapter, as well as the flash window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and its IPL emission activation is by finger switch. If the flash window of the device is not properly applied to the treatment area, the device cannot be triggered a pulse. There are six models in this application: S1-A, S2-A, S1, S2, S3, and S4. According to the declaration of the manufacturer, the difference of all models is mainly the exception of the product appearance, display contents on the display and the spot size of treatment window which does not affect the intended use. The spot size of model S1-A is designed to 3.0cm², model S1, S2, S3, and S4 is designed to 4.1cm², as well as the energy density of the all models is in the range of 2.2~5.6J/cm2.
The provided text is a 510(k) Summary for an IPL Hair Removal Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria for efficacy in hair removal.
Therefore, many of the requested details about acceptance criteria, device performance studies, sample sizes, expert involvement, and ground truth establishment cannot be found in this document.
The document primarily covers:
- Device identification and classification.
- Comparison to predicate devices based on technical specifications (wavelength, energy density, spot size, etc.) and intended use, asserting similarity.
- Performance data related to safety standards: Biocompatibility, Electrical Safety, Eye Safety, and Software Verification and Validation. These are laboratory/engineering tests, not clinical efficacy studies for hair removal.
Here's an attempt to answer the questions based only on the provided text, indicating where information is absent:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for hair removal efficacy or provide reported device performance data in terms of hair reduction percentage or similar metrics. It focuses on demonstrating safety and technical similarity to a predicate device.
However, it does list several safety standards that the device "passed." If we interpret "acceptance criteria" as meeting these standards and "reported device performance" as passing them, then:
| Acceptance Criteria (Testing Standard) | Reported Device Performance |
|---|---|
| ISO 10993-5 Biocompatibility | Passed |
| ISO 10993-10 Biocompatibility | Passed |
| IEC 60601-1-2 Electrical Safety | Passed |
| IEC 60601-1 Electrical Safety | Passed |
| IEC 60601-1-11 Electrical Safety | Passed |
| IEC 60601-2-57 Electrical Safety | Passed |
| IEC 62471 Photobiological Safety | Passed |
| Software Verification & Validation | Software requirement specifications met, hazards mitigated. |
No performance metrics related to hair removal efficacy are provided.
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to engineering and safety testing, not clinical trials on human subjects for efficacy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided. Ground truth in the context of hair removal efficacy usually refers to clinical assessment of hair count or density, often by experts. The document focuses on meeting general safety and electrical standards, not on clinical efficacy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for subjective assessments, typically in expert-based ground truth establishment for clinical trials, which is not described here.
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
An MRMC study is relevant for AI-assisted diagnostic devices. This document is for an IPL Hair Removal Device, which does not involve human "readers" interpreting images with AI assistance. Therefore, this question is not applicable to the content of this document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is an IPL hair removal device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety and electrical standards testing, the "ground truth" is defined by the specific requirements and measurement methods outlined in each referenced ISO/IEC standard. For example, for biocompatibility, it's about whether the device materials cause a specific biological reaction (toxicity, irritation). For electrical safety, it's about whether it meets specified limits for leakage current, insulation, etc.
However, for hair removal efficacy, which is the device's intended function, no ground truth or study data is provided in this summary.
8. The sample size for the training set
This information is not provided. The device is not an AI/ML model that would have a "training set" in the context of deep learning.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/ML model with a training set.
Summary of what is present in the document:
The provided document is an FDA 510(k) summary, which is primarily focused on demonstrating "substantial equivalence" to a previously cleared predicate device. It strongly emphasizes meeting various safety and electrical standards through testing (biocompatibility, electrical safety, eye safety, software validation). It does not contain direct clinical performance data for hair removal efficacy, nor does it describe trials with human subjects for that purpose. The basis for clearance is the demonstrated safety and technical similarity to an already cleared device for the same indication.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.