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The Nuvolase 532 Laser System for Ophthalmology is intended for use in the treatment of vascular lesions of the skin, including capillary hemangioma (port wine stain), strawberry hemangioma, telangiectasia, and rosacea. It is also intended for pigmented lesions including freckles, age spots, café-au-lait, and lentigo.

The Nuvolase 532 Cutaneous Laser System is a continuous-wave frequencydoubled diode-pumped Nd: Y AG laser system. Treatement beam power output for the system is 50 milliwatts to 1.5 watts at a wavelength of 532 nm. The maximum power level to tissue is 2.5 Watts CW. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure durations for the Nuvolase 532 Laser System for Ophthalmology (in seconds) are 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via fiber optic and handpiece.

The provided text describes a 510(k) premarket notification for the "Nuvolase 532 Cutaneous Laser System" and explicitly states it is a modification of a previously cleared device (Nuvolase 660 Laser System, K970667). The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document is a regulatory submission for substantial equivalence based on technological characteristics and intended use, not a clinical study report. Therefore, I cannot provide the requested information.

Here's why each specific point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are present. The submission focuses on demonstrating equivalence to a predicate device.
2. Sample size used for the test set and the data provenance: No test set or study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment process is described.
4. Adjudication method for the test set: Not applicable as there is no test set or study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Conclusion from the document:

The provided document details a 510(k) submission for a laser device, emphasizing its technological equivalence to a predicate device for the treatment of vascular and pigmented skin lesions. It is a regulatory submission asserting substantial equivalence, not a report of a study proving performance against acceptance criteria.

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