(137 days)
The Hair Removal Devices (models IPL-D26 and IPL-D19) are over the counter devices intended for the removal of unwanted hair. The devices are intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
The Hair Removal Devices (Model:IPL-D26,IPL-D19) are pulsed light hair removal devices. The IPL-D26 and IPL-D19 models use the same components and have the same features except for their color. The IPL-D26 is white and IPLD19 is red. The device uses light pulses to produce hair removal, and the effect of the device is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The IPL-D26 and IPL-D19 devices are each composed of a hand held applicator and an external power supply. Each applicator contains a xenon lamp, a skin color sensor and a skin proximity sensor. The xenon lamp emits the pulsed light flashes to produce hair removal. The skin color sensor is to ensure that the light will be emitted only to skin color appropriate for the device. The contact sensor is to ensure that the light pulses will not be emitted unless the applicator in full contact with the skin. The spot size (treatment area) in the Hair Removal Device devices is 3 cm²
This document is a 510(k) summary for a hair removal device, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI performance, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone AI performance, and ground truth establishment is not applicable.
The document describes the device, its intended use, a comparison to a predicate device, and various performance tests conducted to demonstrate safety and substantial equivalence for a non-AI medical device.
Key information provided in the document (and why it doesn't fit the AI/ML criteria):
- Device Type: The device described is a Hair Removal Device (models IPL-D26, IPL-D19) that uses pulsed light (IPL) technology. It is not an AI/ML powered device.
- Intended Use: The device is intended for permanent reduction in hair regrowth. This is a functional claim for a physical device, not an analytical claim for an AI algorithm.
- Performance Data: The performance data section ([7. PERFORMANCE DATA] on page 5) details:
- Biocompatibility testing: Conducted according to ISO 10993-1. (Irrelevant for AI performance)
- Electrical safety and electromagnetic compatibility: Compliance with IEC 60601-1 series and IEC 62471. (Irrelevant for AI performance)
- Software Verification and Validation Testing: This is about the device's control software, not an AI algorithm for image analysis or diagnosis. The software was deemed "Moderate" level of concern, indicating basic safety V&V, not AI validation. (Irrelevant for AI performance criteria)
- Usability: Compliance with IEC 60601-1-6. (Irrelevant for AI performance)
In summary, as this 510(k) submission pertains to a conventional medical device (IPL hair removal device) and not an AI/ML algorithm, the detailed acceptance criteria and study design elements relevant to AI/ML evaluation as requested are not present in this document.
§ 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.