PALLAS 308/311 Solid-State UV Laser System

• K Number: K172639
• Device Name: PALLAS 308/311 Solid-State UV Laser System
• Manufacturer: Laseroptek Co.Ltd
• Date Cleared: 2017-11-03 ( 63 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K024020 , K152856 , K020847 , K062963

Intended Use

The indications for use are UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin.

Device Description

Laseroptek Co. Ltd.'s PALLAS 308/311 Solid-State UV laser system is a self-contained ultraviolet laser light source and optical energy delivery system that provides targeted energy to the treatment site while avoiding exposure to non-affected tissue. The light source is contained within the protective console. The complete system also includes a hand piece connected to the console via an articulating arm. Timing and dosing parameters and the user interface are controlled through a display on the console. The delivery system allows UV-B light to pass through the hand piece to selectively treat skin legions without exposure to the unwanted skin.

AI/ML Overview

The provided text describes the PALLAS 308/311 Solid-State UV Laser System and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-driven medical device.

The document is a 510(k) premarket notification for a laser system. It focuses on demonstrating that the new device is substantially equivalent to existing predicate devices based on:

• Intended Use: UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma.
• Technological Characteristics: Comparison of wavelength, pulse characteristics, output energy, fluence, and physical characteristics.
• Performance Data: Non-clinical tests measuring wavelength, average output power, and energy fluence, and compliance with various IEC and ISO consensus standards for electrical safety, electromagnetic compatibility, laser safety, and risk management. Biocompatibility of patient-contacting materials is also mentioned.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to an AI/algorithm.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
6. Standalone performance of an algorithm.
7. Type of ground truth (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document pertains to a physical medical device (a laser system) and its performance is evaluated through engineering and safety standards, not through AI/algorithm performance metrics with associated testing methodologies.

Regulation Number and Section

§ 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.