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The Nio 2MP Medical Grayscale Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

The Nio 2MP device is a digital image display system. The Barco Nio 2MP device consists of components to provide high resolution visualization of digital images.

The provided document is a 510(k) summary for the Barco Nio 2MP Medical Grayscale Display System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document is a regulatory approval letter and a summary of the device for submission to the FDA. It declares the device substantially equivalent to a previously approved device. This type of submission rarely includes detailed performance studies like those one would expect for a diagnostic AI device.

Therefore, I cannot fulfill your request for the tables and information related to acceptance criteria and study details based on the provided text. The document simply serves as official notification of FDA clearance.

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