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The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.

The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.

The provided text is a 510(k) premarket notification approval letter for the "DEXIS Software." This document primarily focuses on the regulatory approval process and does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance.

Therefore, I cannot provide the information requested from the given text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include the results of performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications.

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