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21.3-inch (54cm) Monochrome LCD Monitor MDL2121A (ME253i2) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.

MDL2121A (ME25312) is a 21.3-inch Monochrome LCD Monitor that supports DVI video signal and provides UXGA (1600 x 1200) resolution for both landscape and portrait display.

The provided text describes a 510(k) submission for a medical monitor and does not contain information about a study with acceptance criteria being met by a device that processes or analyzes medical data (e.g., AI/ML device). The document focuses on the regulatory clearance process for a 21.3-inch Monochrome LCD Monitor for displaying medical images; it is not a diagnostic device with performance metrics related to, for instance, sensitivity or specificity for a particular condition.

Therefore, I cannot extract the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, or ground truth establishment because it is not present in the provided text.

The closest relevant information, regarding the device (the monitor) meeting its intended function, is implicit in the FDA's 510(k) clearance, which states the device is "substantially equivalent" to a predicate device for displaying and viewing medical images. However, this equivalence is about the display's technical characteristics and intended use, not its performance in a clinical diagnostic task.

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