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The MeDis 5MP2 Aura is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.

The MeDis 5MP2 Aura device is a digital image display system

The provided text is a 510(k) summary for the Barco MeDis 5MP2 Aura, a medical image display system. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it is a notification of substantial equivalence to a predicate device rather than a performance study report.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. Ground truth establishment for the training set.

The document's purpose is to establish that the "MeDis 5MP2 Aura" is substantially equivalent to a previously cleared device (Barco NV Display Systems MeDis 5MP2 Quad-Head Medical Diagnostic Display System, K001748), based on its intended use and technological characteristics. It does not present a de novo performance study.

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