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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.

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The indications 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 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.

Ask a specific question about this device