(211 days)
The indication for use are UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin.
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.
The provided text is a 510(k) Summary for a medical device, the PALLAS 308/311 Solid-State UV Laser System. It outlines the device's technical characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence for FDA clearance.
However, this document does not contain information about a study that proves the device meets specific acceptance criteria based on AI/algorithm performance, human reader improvement with AI assistance, or expert consensus on a test set. The performance data section refers to non-clinical tests (measurement of wavelength, output power, energy fluence) and compliance with various consensus standards related to electrical safety, electromagnetic compatibility, usability, risk management, and software validation for a laser system, not an AI-driven medical device.
Therefore, I cannot provide the requested information related to acceptance criteria and study details for an AI-driven device, as the provided document concerns a UV laser system and its substantial equivalence to a predicate device, based on engineering and safety standards, not AI-specific performance.
Specifically, the document does not mention:
- A table of acceptance criteria with reported device performance for an AI/algorithm.
- Sample sizes for a test set or data provenance for AI model validation.
- The number or qualifications of experts for ground truth establishment.
- Adjudication methods for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- The type of ground truth (e.g., pathology, outcomes data).
- Sample size for a training set or how its ground truth was established.
The "Performance Data" section details non-clinical tests of the laser's physical parameters and compliance with electrical and safety standards, which are typical for laser devices seeking 510(k) clearance via substantial equivalence.
§ 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.