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The Coronis 3MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be need in primary image diagnosis in mammography.

Coronis 3MP is a display system for medical viewing. It consists of 3 components: MDCG 3120-CB is a 20.8" grayscale LCD display. MXRT 5100 is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal QAWeb Agent for a softcopy QA software application for local calibration and QA control.
The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.

The provided text describes a 510(k) submission for the Barco Coronis 3MP display system. This document focuses on establishing substantial equivalence to a predicate device (Coronis 2MP-21") rather than demonstrating performance against specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided text. The submission is a regulatory filing for a medical device display, emphasizing its technical characteristics and intended use, and declaring it "substantially equivalent" to an existing device, which is a different type of assessment than proving efficacy or performance against clinical metrics.

The "conclusion" section explicitly states: "The 510(k) Pre-Market Notification for the Barco Coronis 3MP contains adequate information and data to enable FDA – CDRH to determine substantial equivalence to the predicate device." This indicates the nature of the submission.

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