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The MDMC - 12133 is intended to be used in displaying digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners.

It is especially designed for breast tomosynthesis (3D mammography) applications, breast US.

It is especially designed for CT and ultrasound including vascular and gynecological US.

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The provided document is an FDA 510(k) clearance letter for the Barco Coronis Uniti, a Picture Archiving and Communications System (PACS) display device. This document confirms the device's substantial equivalence to a legally marketed predicate device.

Crucially, this document does not contain information about acceptance criteria, detailed study designs, sample sizes, expert qualifications, adjudication methods, or specific performance metrics that "prove the device meets the acceptance criteria."

The clearance letter focuses on regulatory approval, stating that the device is substantially equivalent to existing devices and is subject to general controls. It does not include the technical detail and study results typically found in a clinical or performance evaluation report.

Therefore, I cannot fulfill your request for the tables and information based solely on the provided text, as this information is not present. The document explicitly states its purpose is to grant clearance for marketing based on substantial equivalence, not to provide a detailed performance study report.

To answer your questions, I would need a different type of document, such as a formal clinical study report, a performance validation report, or a summary of safety and effectiveness data (SSED) that would typically accompany a 510(k) submission but is not included in this clearance letter.

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