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The Barco MGD 521 5 MegaPixel Diagnostic Display is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.

The MGD 521 device is a diagnostic display. The Barco MGD 521 is a electronic resolution monitor with high resolution capabilities for evaluation of high medical images.

This is a medical device, a Monitor/Display, not an AI/ML device, so many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

Not applicable. This is a hardware display device, not an AI/ML diagnostic tool that processes a "test set" of medical images.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The device's performance is based on its technical specifications for displaying images, not on expert interpretations of data it processes.

4. Adjudication Method

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a display monitor, not an AI system designed to assist human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a display, not an algorithm.

7. Type of Ground Truth Used

Not applicable. The "ground truth" for a display device would primarily relate to its technical specifications (e.g., resolution, brightness, contrast, color accuracy) and its ability to accurately render images as intended by the source, rather than a clinical ground truth like pathology or outcomes data.

8. Sample Size for Training Set

Not applicable. This is a hardware device; it does not have a "training set" in the context of machine learning.

9. How Ground Truth for Training Set Was Established

Not applicable.

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