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FlexScan MX300W is intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. FlexScan MX300W does not support the display of mammography images for diagnosis.

FlexScan MX300W is a 76cm (29.8") Color LCD display for medical image viewing and digital images viewing. MX300W displays high-definitions medical imaging.

The provided text is a 510(k) summary for a medical monitor (Color LCD Monitor, FlexScan MX300W). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about a study that assesses the device's performance against specific acceptance criteria related to its diagnostic accuracy or the impact of AI on human readers.

This type of submission for a display device primarily focuses on technical specifications and demonstrating that the new device is substantially equivalent to an already approved predicate device. It doesn't involve the kind of comparative effectiveness studies or standalone algorithm performance evaluations that would be documented for an AI-powered diagnostic device.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

1. A table of acceptance criteria and reported device performance: This would typically involve metrics like sensitivity, specificity, accuracy, or other performance indicators, which are not discussed for this monitor.
2. Sample size used for the test set and data provenance: No test sets are described for evaluating diagnostic performance.
3. Number of experts used to establish ground truth and their qualifications: Ground truth establishment is not relevant in this context for a monitor.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This is a display device, not an AI diagnostic algorithm, so no such study is described. There's no mention of AI or its effect on human readers.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a display device, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on the monitor's technical characteristics (e.g., panel size, resolution, Digital Uniformity Equalizer, brightness) and its intended use for displaying digital images for diagnosis by trained medical practitioners, specifically excluding mammography. It establishes substantial equivalence to the RadiForce R31 monitor (K052344) based on these technical aspects.

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