(97 days)
Diode Laser Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Diode Laser Har Removal is also intended for permanent reduction in hair regrowth defined as a 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.
The Diode Laser Hair Removal device models LHR-V8S-810, LHR-V8-810, LHR-V4S-810, and LHR-V4-810 emit pulses of invisible infrared laser light of 810mm wavelength that penetrates into the skin and is selectively absorbed by melanin in the hair follicles. This creates a localized thermal effect that disrupts hair growth from the hair follicles. The device contains a sensor that detects contact with the skin so that the device will only emit the infrared laser pulses when the sensor is in contact with the skin. The device also includes a skin cooling feature and the device is powered by an external AC/DC power adaptor.
The provided document describes a 510(k) premarket notification for a Diode Laser Hair Removal device. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered medical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and safety/performance testing of physical aspects of the device, not its AI/ML performance.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance (for AI/ML).
- Sample size for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size.
- Standalone performance (AI/ML without human-in-the-loop).
- Type of ground truth used (for AI/ML).
- Sample size for the training set.
- How ground truth for the training set was established.
The document lists "Performance Data" which includes Biocompatibility Testing and Electrical, EMC, and laser output, Safety and Performance Testing. These are standard safety and engineering tests for a physical medical device, not performance studies for an AI/ML algorithm.
§ 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.