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The MGD 521M display is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It is specifically intended for use with any digital mammography system for which the MGD 521M device meets the criteria specified by the manufacturer of the digital mammography system.

The MGD 521M device is a digital image display system, image monitor/display, and others workstation, image processing

This document describes the 510(k) summary for the Barco MGD 521M, a 5-megapixel diagnostic display intended for displaying and viewing digital mammography images. The submission asserts substantial equivalence to the Barco NV Display Systems MGD 521 (K980541).

Acceptance Criteria and Device Performance:

The document does not explicitly state quantitative acceptance criteria or a detailed "device performance" section in the traditional sense of a clinical or technical study outcome. Instead, the acceptance criteria for the Barco MGD 521M appear to be defined by its conformity to the specifications required by digital mammography system manufacturers and the functional equivalence to its predicate device.

The "reported device performance" in this context is the statement that the device is a "high resolution monitor with electronic capabilities for evaluation of high resolution digital images." The focus is on meeting the technical characteristics required for displaying such images accurately for review by trained medical practitioners.

The critical acceptance criterion is implicit: the Barco MGD 521M must meet the criteria specified by the manufacturer of the digital mammography system with which it is intended to be used. Furthermore, its performance must be "substantially equivalent" to the predicate device, the Barco NV Display Systems MGD 521 (K980541).

Study Information (Based on the provided text):

The provided 510(k) summary and FDA letter do not describe a specific clinical study or technical validation study with detailed methodology, sample sizes, or ground truth establishment relevant to performance metrics like sensitivity, specificity, or reader agreement. This type of submission (for a display monitor) typically focuses on technical specifications, safety, and substantial equivalence to a previously cleared predicate device, rather than a clinical trial assessing diagnostic accuracy of the display itself.

Therefore, many of the requested items cannot be directly answered from the given text.

1. Sample size used for the test set and the data provenance: Not applicable/Not provided. The document does not describe a test set or clinical data used to evaluate diagnostic performance. The criteria refer to the display's technical capability to show images, not to interpret them.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No test set requiring expert ground truth establishment is mentioned for this device.
3. Adjudication method for the test set: Not applicable/Not provided.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a display monitor, not an AI-assisted diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware display device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided.
7. The sample size for the training set: Not applicable/Not provided. This device is a display monitor and does not use a training set in the context of machine learning.
8. How the ground truth for the training set was established: Not applicable/Not provided.

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