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The Coronis 2MP-21" is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

The MFGD 2621 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Coronis 2MP-21" is a display system for medical viewing. It consists of 3 components: MFGD 2621 is a 21.3" grayscale LCD display. BarcoMed Coronis is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal Pro is user-friendly softcopy OA software. The display system can be a single-head system or multi-head system. In the last case it ontains multiple displays and display controller boards.

MFGD 2621 is a 21.3" grayscale LCD display for medical viewing. It is combined with MediCal Pro, a user-friendly softcopy QA software.

The provided text describes two devices, Coronis 2MP-21" and MFGD 2621, both intended for displaying medical images. However, the document does not detail any specific acceptance criteria or study results that prove the devices meet such criteria.

The 510(k) summaries primarily focus on establishing substantial equivalence to predicate devices (Coronis 2MP and MFGD 2320, respectively) based on technological characteristics, general function, application, and intended use. The conclusion for both devices explicitly states: "Any difference between both devices does not affect safety or efficacy." This implies that the devices are considered safe and effective because they are similar enough to already-approved devices, rather than through independent studies against predefined performance metrics.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for either a test set or training set. These elements are not present in the provided document.

The document is a 510(k) premarket notification for substantial equivalence, which often relies on a comparison to a predicate device rather than presenting new study data with acceptance criteria and performance metrics.

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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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