(37 days)
The Home use hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas with Fitzpatrick Skin Phototypes I-V.
The Home use 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 technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The 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 a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the skin of the treatment area, the device will not emit light pulses.
The provided document is a 510(k) summary for a medical device called "Home Use Hair Removal Device." It describes the device, its intended use, and its comparison to a predicate device to establish substantial equivalence for regulatory clearance. This type of document is not an academic study or a report of clinical trial results directly proving the device meets specific performance criteria for efficacy in the same way a diagnostic AI device would.
Therefore, the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a diagnostic AI device is largely not applicable to this regulatory submission for a hair removal device.
The "performance data" section in this document refers to:
- Biocompatibility Testing: Ensuring the materials are safe for contact with the human body.
- Electrical Safety and Eye Safety Testing: Verifying the device's electrical components and light emission are safe according to established standards.
- Software Verification and Validation: Confirming the software functions as intended and mitigates hazards.
These are safety and engineering performance criteria, not clinical efficacy metrics for hair removal, which are typically assessed through different types of studies not detailed here. The 510(k) process relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing independent clinical proof of efficacy against strict, quantitative acceptance criteria for clinical performance like sensitivity or specificity.
However, I can extract and structure the information that is present, noting where the requested details are not available or not relevant to this type of device and submission.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for a physical, light-based hair removal device, the "acceptance criteria" are primarily related to safety, electrical performance, and biocompatibility, rather than clinical efficacy metrics like sensitivity or specificity for a diagnostic algorithm. The document states that the device "passed" these tests, implying they met the requirements of the cited standards.
| Acceptance Criterion Type | Standard/Test Performed | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-5 (Cytotoxicity) | Passed |
| ISO 10993-10 (Irritation & Skin Sensitization) | Passed | |
| ISO 10993-23 (Irritation) | Passed | |
| Electrical Safety | IEC 60601-1, -1-2, -1-6, -1-11 | Passed |
| IEC 60601-2-57, -2-83 | Passed | |
| Eye Safety (General Light Source) | IEC 62471 (Photobiological Safety of Lamps) | Passed |
| Software | Verification & Validation | "All software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." |
2. Sample size 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 510(k) summary. The listed "performance data" refers to technical safety tests rather than clinical studies with human subjects and test sets for efficacy measurement. The summary does not provide details on the number of units tested for electrical safety, biocompatibility, or software validation, nor does it specify the provenance of such test data.
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 applicable and not provided. "Ground truth" in the context of expert consensus is typically relevant for diagnostic devices that interpret complex medical images or data. For a hair removal device, the "ground truth" would be the physical removal of hair, often evaluated in clinical trials which are not explicitly detailed in this 510(k) summary beyond a general assertion of "safety and effectiveness profile that is similar to the predicate device."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are used in studies involving expert review of diagnostic findings to establish ground truth, which is not the focus of the performance data presented 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
This information is not applicable and not provided. MRMC studies are specific to evaluating diagnostic algorithms, often with human-in-the-loop components. This device is a standalone hair removal product, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of diagnostic AI. The device itself is a standalone physical product that performs hair removal. The "software verification and validation" addresses the performance of the embedded software, but not as a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly detailed for hair removal efficacy as it relates to clinical studies. For the technical performance data provided:
- Biocompatibility: Ground truth is established by standardized chemical and biological assays that evaluate material interactions with biological systems against predefined acceptable limits.
- Electrical and Eye Safety: Ground truth is established by physical measurements and tests against the specified limits of the IEC standards.
- Software: Ground truth is established by predefined software requirements and hazard mitigations, verified through testing.
8. The sample size for the training set
This information is not applicable and not provided. This device is not an AI/ML-based diagnostic algorithm that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reason as point 8.
§ 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.