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The MFGD 2320 device is intended to be used in displaying and viewing digital images for review by trained medical practitioners.

The MFGD 2320 20 Inch 2 Megapixel Grayscale LCD Display is intended to be used as a tool in displaying and viewing digital images (excluding digital Mammography) for review and analysis by trained medical practitioners.

The MFGD 2320 is a diagnostic display

The MFGD 2320 device is a high resolution monitor with electronic capabilities for evaluation of high resolution medical images.

I am sorry, but the provided text does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical display device (MFGD 2320 20 Inch 2 Megapixel Grayscale LCD Display) and primarily focuses on its regulatory clearance, intended use, and substantial equivalence to a predicate device.

Specifically, the text does not include:

• A table of acceptance criteria or reported device performance metrics like sensitivity, specificity, or accuracy.
• Details on sample size, data provenance, number of experts, adjudication methods for test sets.
• Information about multi-reader, multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used or how it was established for training and testing.
• Training set sample size.

The document states: "The MFGD 2320 device is a high resolution monitor with electronic capabilities for evaluation of high resolution medical images." and "The MFGD 2320 20 Inch 2 Megapixel Grayscale LCD Display is intended to be used as a tool in displaying and viewing digital images (excluding digital Mammography) for review and analysis by trained medical practitioners."

This is a regulatory filing for a display device, not an AI or diagnostic software, so the types of studies and performance metrics you are asking for (e.g., sensitivity, specificity, ground truth establishment, MRMC studies) are not typically applicable or detailed in such a submission. The substantial equivalence determination for a monitor like this would likely be based on technical specifications (resolution, luminance, contrast, etc.) matching or exceeding a legally marketed predicate device, rather than diagnostic performance in a clinical study.

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