(62 days)
Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The 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.
Ice Cooling IPL Hair Removal Device is an oversonal device for har reduction by using Intense Pulsed Light (PL). It is designed with a lamp that can emit continuously double of this surface and does not involve any cuting or pulling, reducing har growth with nearly painless pain. The device is only powered by the external pover adapter activation is by finger switch. This product adopts spphire treatment window that is suitable for multiple hair removal areas. It contains a skin contact, if the device is not in full contact with the skin, the device canot emit the treatment light pulses. Besides, the device tunction that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
The provided text is a 510(k) summary for the Ice Cooling IPL Hair Removal Device. It details the device's characteristics, comparison to predicate devices, and performance data submitted to support substantial equivalence.
However, the document does not contain the specific information requested regarding an AI/algorithm-based device, namely:
- Acceptance criteria table and reported device performance for an AI/algorithm. The document focuses on performance data for a non-AI medical device (biocompatibility, electrical safety, light safety, software verification, usability).
- Sample size and data provenance for a test set.
- Number of experts and qualifications for ground truth establishment.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Stand-alone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/algorithm.
- Sample size for the training set.
- How ground truth for the training set was established.
The device in question, an "Ice Cooling IPL Hair Removal Device," is regulated as a "Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology" (21 CFR 878.4810). While it mentions "Software Verification and Validation" and "Software documentation consistent with Basic Documentation Level," this typically refers to embedded software for device control and safety features, not a diagnostic or prognostic AI algorithm that processes image data to provide clinical insights, which would require the kind of performance study details requested in your prompt.
Therefore, I cannot provide the requested information based on the provided text. The document does not describe a study involving an AI model for which such specific performance metrics and ground truth establishment details would be relevant.
§ 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.