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20.8-inch (53cm) Color LCD Monitor CDL2114A (DV3MC-HB) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.

CDL2114A (DV3MC-HB) is a 20.8-inch color LCD monitor that supports a DVI video signal and provides QXGA (2048 x 1536) resolution for both landscape and portrait display.

The provided document is a 510(k) summary for a medical display monitor (TOTOKU ELECTRIC CO., LTD. 20.8-inch (53cm) Color LCD Monitor CDL2114A (DV3MC-HB)). This document does not contain information about acceptance criteria for an AI/algorithm-based device, nor does it describe a study proving such a device meets acceptance criteria.

The device in question is a display monitor, which is a hardware component. Its substantial equivalence is based on comparisons to a predicate device in terms of physical characteristics (e.g., LCD panel brightness, lifetime, AC adapter capacity), not on algorithmic performance or clinical outcomes.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance because the provided text is for a hardware display monitor, not an AI/algorithm-based medical device that would typically have such studies.

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