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The MD210C3 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.

To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display controllers.

MD210C3 cannot be used for a life-support system.

This device must not be used in digital mammography.

This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.

Medical Display, MD210C3 is a 21.3" Color LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving device performance for a medical AI device.

The document is a 510(k) premarket notification for a diagnostic imaging LCD monitor (MD210C3), not an AI or algorithm-based device. Therefore, it discusses display specifications and comparisons to a predicate display, not AI performance metrics.

Specifically, the document does not contain any of the following information:

• Acceptance criteria for an AI algorithm expressed in terms of metrics like sensitivity, specificity, or AUC.
• Reported device performance (e.g., accuracy, recall) of an AI algorithm.
• Sample sizes for test sets used for AI model evaluation.
• Data provenance (country of origin, retrospective/prospective) for AI data.
• Number of experts or their qualifications for establishing ground truth for AI.
• Adjudication methods for an AI test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study information for AI.
• Standalone performance data for an AI algorithm.
• Type of ground truth used for AI (pathology, outcomes data).
• Sample size for training set of an AI model.
• How ground truth for the training set of an AI model was established.

The document primarily focuses on verifying that the new display (MD210C3) is substantially equivalent to a previously cleared predicate display (MD211C3) by comparing their physical and performance specifications as a display device. It mentions "Display Testing" with items like "Luminance Response" and "Display Resolution," and states "Test results showed minor differences between MD210C3 and MD211C3, however these differences are minor and were within the acceptable range of DICOM part 14." This refers to performance characteristics of a monitor, not an AI algorithm.

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