(78 days)
IPL Hair Removal Device is indicated for the removal of unwanted hair. The IPL Hair Removal Device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The subject device 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, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use. There are BR223, BR225 two models in this application. Their work principle, function, intended use, structure, and composition are the same, with difference being product appearance, but this difference does not affect or change the intended use of the device.
This document is a 510(k) summary for the Shenzhen Borria Technology Co., Ltd. IPL Hair Removal Device. It is a regulatory submission to the FDA, not a study report. Therefore, it does not provide the kind of detailed information about acceptance criteria and study results that you are asking for regarding device performance, particularly for AI/algorithm-based devices.
The document states that "Performance data supports that the device is safe and as effective as the predicate device for its intended use" and "the subject device was found to have a safety and effectiveness profile that is similar to the predicate device." However, it does not present the raw performance data, acceptance criteria, or details of a clinical study in the format you've requested.
The "Performance Data" section (VII) primarily lists safety testing (Biocompatibility, Electrical Safety, EMC Safety, Eye Safety) and software verification/validation, which are important for device safety and functionality, but not for demonstrating a clinical outcome like hair reduction effectiveness with specific performance metrics such as accuracy, sensitivity, or user improvement with AI.
To directly answer your questions based only on the provided text, many details are missing or not applicable, especially concerning an AI/algorithm component. This document describes a traditional medical device (IPL hair removal) rather than an AI-based diagnostic or treatment device that would typically involve acceptance criteria related to AI performance, ground truth establishment, and human-in-the-loop studies.
Here's an attempt to answer your questions based on what is and is not in the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for clinical effectiveness (e.g., hair reduction percentage) or reported device performance against such criteria. It states that performance data was provided to support substantial equivalence to a predicate device, implying that its performance is considered comparable to the predicate.
The table in the document compares "technological characteristics" such as wavelength range, energy medium, energy density, spot size, pulse duration, and pulsing control between the subject device and predicate devices. This shows their technical specifications are similar, not performance against clinical outcomes.
2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set or the sample size used for evaluating hair removal effectiveness, nor does it mention data provenance (e.g., country of origin, retrospective/prospective). The performance data listed (biocompatibility, electrical safety, etc.) refers to standard engineering and safety tests, not clinical efficacy trials with patient sample sizes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. Ground truth establishment with experts is typically relevant for diagnostic or AI-assisted devices where human interpretation is involved. For an IPL hair removal device, effectiveness is usually measured through objective means (e.g., hair counts, photographic assessment by non-interpreting personnel) rather than expert consensus on a diagnostic image.
4. Adjudication method for the test set
Not applicable/not provided. There is no mention of a test set requiring adjudication in the context of clinical performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This type of study is relevant for AI-assisted diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This document describes an IPL hair removal device, which is not an imaging or diagnostic AI product, so an MRMC study would not be applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical IPL hair removal device, not an algorithm.
7. The type of ground truth used
For the safety tests listed (biocompatibility, electrical safety), the "ground truth" would be adherence to the specified ISO and IEC standards. For the clinical effectiveness of hair removal, while not detailed in this summary, the typical ground truth in such studies involves objective hair counts or validated photographic scales taken at specified time points after treatment. However, the document does not specify how effectiveness was measured or what "ground truth" was used for the substantial equivalence claim beyond technical specifications and comparison to predicate.
8. The sample size for the training set
Not applicable. The IPL Hair Removal Device is not an AI/machine learning model, so there is no "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI model.
§ 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.