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The Data Ray Corporation DR11021 Medical Imaging Monitor is intended to be used by radiologists/trained practitioners to examine digitized x-ray images for the purpose of medical analysis.

The Data Ray Corporation DR11021 Medical Imaging Monitor is used in filmless radiology systems to display digitized x-ray images. These digitized x-ray images are viewed by trained medical providers for the purpose of diagnosing and/or treating illnesses in human beings.

The DR11021 Medical Imaging Monitor is a diagnostic display used in film-less radiology applications.

The Data Ray Corporation DR11021 Medical Imaging Monitor is a high resolution monitor with the electronic capability necessary for displaying high resolution medical images for the purpose of evaluation.

The provided document is a 510(k) Premarket Notification Summary for the "DR11021 Medical Imaging Monitor" by Data Ray Corporation. This document concerns a medical display monitor and does not contain any information about acceptance criteria or a study proving device performance for an AI/CADe device.

The document describes the monitor's intended use (displaying digitized X-ray images for medical analysis by radiologists/trained practitioners) and its technological characteristics (high-resolution display). It also lists substantially equivalent predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance, as the provided text does not contain this information.

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