(61 days)
IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
The subject device IPL Cooling 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 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.
The provided text is a 510(k) Pre-market Notification for an IPL Cooling Hair Removal Device. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it does not contain the specific information required to complete the table and answer all the questions about acceptance criteria and the study proving the device meets those criteria.
The document primarily focuses on:
- Device Description: What the device is and how it works (IPL technology for hair reduction).
- Comparison to Predicate Device: Technological characteristics like wavelength range, energy density, spot size, pulse duration, and indications for use.
- Performance Data: This section outlines types of testing performed (Biocompatibility Safety, Electrical Safety and EMC Safety, Eye Safety, Software Verification and Validation) and states that the tests passed.
Missing Information:
The document explicitly states that "Performance data supports that the device is safe and as effective as the predicate device for its intended use." However, it does not provide quantitative acceptance criteria or the specific numerical results of those tests (reported device performance) for comparison. It only lists the types of tests performed and the standards they adhered to.
Specifically, the document does not contain any information regarding clinical performance studies, human reader studies, or the establishment of ground truth for such studies. The performance data provided are related to electrical safety, biocompatibility, eye safety, and software validation, which are typically assessed against published standards rather than through clinical effectiveness studies with explicit acceptance criteria for diagnostic or treatment accuracy.
Therefore, I cannot fully complete the table or answer questions 2-9 based on the provided text.
Here's how I can address what is available and highlight the missing parts:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Conformance to ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization) | Passed: Tests performed and passed in accordance with ISO 10993-5 and ISO 10993-10 for patient-directly contacting components. |
| Electrical Safety & EMC Safety: Conformance to IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-83 | Passed: Tests performed and passed against specified IEC standards. |
| Eye Safety: Conformance to IEC 62471 | Passed: Test performed and passed against IEC 62471. |
| Software Verification and Validation: Software documentation consistent with moderate level of concern; all software requirement specifications met; all software hazards mitigated to acceptable risk levels. | Passed: System validation testing demonstrated all software requirement specifications met and hazards mitigated. |
| Clinical Effectiveness for Hair Removal: (This information is missing from the document for the subject device. The document only states it's "as effective as the predicate device" without providing specific acceptance criteria or results from a clinical study for the subject device.) | (Specific performance data for hair removal effectiveness is not provided in this document.) |
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 document. The document describes engineering and biocompatibility tests, not clinical studies with patient test sets.
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 as no clinical effectiveness study with human assessment of ground truth is detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as no clinical effectiveness study requiring expert adjudication is detailed.
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 provided. The device is an IPL hair removal device, not an AI-assisted diagnostic tool, so an MRMC study is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. This is not an AI algorithm, but a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety and performance tests mentioned (biocompatibility, electrical safety, eye safety, software), the "ground truth" is defined by the technical standards (e.g., ISO, IEC). For clinical effectiveness (hair removal), no specific ground truth methodology is described for the subject device, although it is asserted to be "as effective as" the predicate.
8. The sample size for the training set
This information is not provided as it's not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
This information is not provided as it's not an AI/machine learning device requiring a training set.
§ 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.