(75 days)
IPL hair removal is an over-the-counter device intended for removal of unwanted body hair.
The IPL hair removal is a personal, light-based, hair reduction device intended to be sold overthe-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 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 in full contact with the skin, the device cannot emit the light pulse.
The IPL hair removal includes FZ-610, FZ-612, FZ-611, FZ-613, and FZ-608 six models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly contains product appearance and its spot size of the treatment window, but these differences do not affect or change the intended use of the device.
The provided document is an FDA 510(k) clearance letter for an IPL hair removal device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of the device's performance against specific acceptance criteria for a novel AI or medical imaging device.
Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth, and multi-reader comparative effectiveness are not applicable or cannot be extracted from this document, as it describes a non-AI, non-diagnostic device.
However, I can extract information related to the device's performance data and safety testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization) for patient-contacting components (ABS plastic). | Passed ISO 10993-5: Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity |
| Passed ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization | ||
| Electrical Safety | Compliance with IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-57. | Passed IEC 60601-1-2: Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility |
| Passed IEC 60601-1: Medical electrical equipment -Part 1: General requirements for basic safety and essential performance | ||
| Passed IEC 60601-1-11: Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment | ||
| Passed IEC 60601-2-57: Medical electrical equipment -- Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use | ||
| Eye Safety | Compliance with IEC 62471. | Passed IEC 62471: Photobiological safety of lamps and lamp systems |
| Software Verification and Validation | Software documentation consistent with moderate level of concern, demonstrating all software requirement specifications are met and all software hazards mitigated to acceptable risk levels. | System validation testing demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
Regarding the other points:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This document describes safety and performance testing against standards, not a clinical efficacy study with a test set of patient data in the context of AI or diagnostics.
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)
- Not applicable/Not provided. This document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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
- Not applicable. This is not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" here is the adherence to established international safety and biocompatibility standards (e.g., ISO, IEC). This is a technical compliance assessment, not a clinical diagnostic performance assessment.
8. The sample size for the training set
- Not applicable. This is not an AI device that undergoes a "training set" process.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.