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The Xenon BrightStar Illumination System is intended to provide intraocular illumination in vitreoretinal surgery.

The Xenon BrightStar Illumination System consists of the Illumination Unit and accessories. The Illumination Unit uses a Xenon Short Arc Lamp and utilizes two internal focusing systems to focus the light into the end of an optical fiber of two individually controlled ports. Both ports can be individually controlled by choice of an UV cut-off filter and a light intensity setting. Accessories trother system include single use and reusable fiber optic probes, fibers and micro instruments which are delivered sterile or require sterilization prior to use.

This 510(k) summary describes a traditional medical device (an ophthalmic light source), not an AI/ML-driven device. As such, it does not contain the information requested in your prompt regarding acceptance criteria, study details, expert involvement, or AI performance metrics.

The document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and intended use. There is no mention of a study to "prove the device meets acceptance criteria" in terms of algorithmic performance, as this device does not involve an algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and study details for an AI/ML device based on the provided text.

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