(30 days)
The Ice Cooling IPL Home Use Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small as underarm and facial hair below the chin line and large areas such as legs.
The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The Ice Cooling IPL 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 and it has the cooling function that effectively cools the skin.
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. Besides, the device has the cooling function that will be activated throughout the whole hair removal process or when the user want to activated to provide users with a more comfortable experience.
The provided document is a 510(k) summary for an Ice Cooling IPL Home Use Hair Removal Device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials.
Therefore, it is not possible to fully answer all aspects of your request based on the provided text alone, as it lacks a standalone clinical study section with detailed acceptance criteria, sample sizes, expert involvement, and ground truth establishment for performance.
However, I can extract information related to the device's alignment with safety and performance standards which serve as a form of acceptance criteria in the context of a 510(k) submission.
Here's the information that can be gleaned from the document:
1. A table of acceptance criteria and the reported device performance
The document lists several international and FDA-recognized standards that the device conforms to. While these are not "performance" metrics in terms of hair reduction efficacy, they represent acceptance criteria for safety, electrical compatibility, usability, and photobiological safety.
| Acceptance Criteria (Standards Conformance) | Reported Device Performance (Conformance) |
|---|---|
| IEC 60601-1 (Basic Safety & Essential Performance) | Conforms |
| IEC 60601-1-2 (Electromagnetic Disturbances) | Conforms |
| IEC 60601-1-6 (Usability) | Conforms |
| IEC 60601-1-11 (Home Healthcare Environment) | Conforms |
| IEC 60601-2-57 (Non-laser light source for therapeutic/cosmetic use) | Conforms |
| IEC 60601-2-83 (Home light therapy equipment) | Conforms |
| IEC 62471 (Photobiological Safety) | Conforms |
| IEC 62366-1 (Usability Engineering for Medical Devices) | Conforms |
| ISO 10993-5 (In-Vitro Cytotoxicity) | Conforms |
| ISO 10993-10 (Irritation and Skin Sensitization) | Conforms |
| ISO 10993-23 (Tests for Irritation) | Conforms |
| Software Verification and Validation | Performs as intended (according to FDA Guidance) |
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 submission focuses on non-clinical engineering and biocompatibility testing against standards, and comparison to predicate devices, rather than a clinical performance study with a specific test set of human subjects.
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 therefore not provided, as the document does not describe a clinical study with a ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided, as the document does not describe a clinical study with a test set requiring adjudication.
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 therefore not provided. This device is an IPL hair removal device, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and therefore not provided. The device is a hardware product for hair removal, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests (electrical safety, photobiological safety, biocompatibility, software V&V), the "ground truth" or reference is adherence to the specified international and FDA-recognized standards. For the claimed "permanent reduction in hair regrowth," the document states it is "defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime." However, explicit outcomes data from a clinical trial to prove this ground truth for the subject device is not presented in this summary, rather the substantial equivalence to predicate devices that have this indication is leveraged.
8. The sample size for the training set
This information is not applicable and therefore not provided. There is no mention of machine learning or AI models with training sets for this device.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided, as there is no training set for a machine learning 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.