(56 days)
PALLAS Premium is Solid-State Ultraviolet laser system for treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.
This device consists of a power supply unit, a cooling system, a controller, and a laser resonator, and is controlled by a microprocessor. When electric energy pumping is applied to the flash lamp, the laser is emitted through a device laser module that oscillates a laser with a wavelength of 311mm, and the laser is radiated through the end of the optical fiber, which is a laser carrier.
The provided text is a 510(k) Summary for the PALLAS Premium device, a Solid-State Ultraviolet laser system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance studies typical for novel AI/ML medical devices.
Therefore, the information required to answer your prompt, specifically concerning acceptance criteria and detailed study performance (like MRMC studies, specific performance metrics, ground truth establishment for test/training sets, and expert qualifications for data annotation), is not present in the provided text.
The "Performance Data" section discusses compliance with various electrical safety, electromagnetic compatibility, laser safety, and software validation standards, but it does not include any clinical performance data or acceptance criteria related to the device's efficacy or accuracy in treating the specified conditions (psoriasis, vitiligo, atopic dermatitis, and leukoderma). The document asserts equivalency based on technical characteristics and intended use, implying that clinical performance is expected to be similar to the predicates.
This type of 510(k) submission generally relies on the established safety and effectiveness of the predicate devices. The device described, PALLAS Premium, is a physical laser system, not an AI/ML algorithm requiring studies to demonstrate diagnostic or prognostic accuracy.
If this were an AI/ML device, the detail you requested would be crucial for determining its clinical utility and safety. However, for a laser surgical instrument, the focus of the 510(k) submission is on demonstrating safety through adherence to recognized standards and technical similarity to legally marketed devices.
§ 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.