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The Coronis 5MP (MDCG-5221) display is intended to be used in displaying digital images, for review and analysis by trained medical practitioners. It is designed for radiology and digital mammography applications.

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The provided text is a 510(k) premarket notification approval letter for the Barco Coronis 5MP (MDCG-5221) display device. This document confirms the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory requirements.

However, this document does not contain specific information regarding:

• Acceptance criteria for device performance.
• The details of any study conducted to prove the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance (country, retrospective/prospective).
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

The document is an administrative approval, not a technical study report. Therefore, I cannot extract the requested information from the provided text.

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The Coronis 5MP (MDCG-5121) display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

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This document is an FDA 510(k) clearance letter for the Barco N.V. Coronis 5MP (MDCG-5121) display device. It confirms that the device is substantially equivalent to a legally marketed predicate device for displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

The document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies. This type of information is typically found in the 510(k) summary or the full submission, not in the clearance letter itself.

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The Coronis 5MP HD (MDMG-5121) Display is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the Coronis 5MP HD (MDMG-5121) display device. This document primarily focuses on the regulatory clearance process and does not contain the detailed technical specifications, acceptance criteria, or study results that would typically be found in a performance study report.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC study details from this document.

The document states the device's indications for use:
Indications For Use: The Coronis 5MP HD (MDMG-5121) Display is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.

To answer your questions, I would need access to the actual technical documentation, validation reports, or performance studies submitted by Barco n.v. to the FDA, which are not part of this 510(k) clearance letter.

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The Coronis 5MP Mammo SL (MDMG 6121) Display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

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This FDA 510(k) clearance letter for the Barco Coronis 5MP Mammo SL states that the device is intended for displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. However, the provided document does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The letter is a regulatory filing indicating substantial equivalence to a predicate device, which means it met the administrative requirements for marketing. It does not include performance data, study design, or any of the detailed information requested in the prompt regarding acceptance criteria and performance studies.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment based on the provided text.

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The Coronis 5MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images, including digital mammography, for review by trained medical practitioners.
The Coronis 5MP Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

The Coronis 5MP device is a digital image display system
The Coronis 5MP device consists of components to provide high resolution visualization of digital images.

This document is a 510(k) summary for the Barco Coronis 5MP Medical Flat Panel Display System, a digital image display system intended for viewing digital images, including digital mammography.

1. Table of Acceptance Criteria and the Reported Device Performance:

The provided document does not contain a table of acceptance criteria or reported device performance in the typical sense of quantitative metrics for an AI device. Instead, it describes a medical device (a display system) and seeks substantial equivalence to existing devices. The "performance" being assessed here is the device's ability to display images adequately for medical review, and the acceptance is based on meeting the regulatory requirements for such a display system.

However, based on the context of a 510(k) for a display system, the implicit acceptance criteria would revolve around the display's ability to accurately and sufficiently present medical images, particularly for mammography. This would typically involve:

2. Sample size used for the test set and the data provenance:

• No specific test set or data provenance is mentioned. This document is a regulatory submission for a display device, not a study evaluating an AI algorithm's diagnostic performance on a dataset of patient images. The evaluation is focused on the characteristics of the display itself and its equivalence to other legally marketed predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. As this is a display device, there's no "ground truth" establishment in the context of diagnosing cases. The evaluation focuses on technical specifications of the display and its suitability for medical image review.

4. Adjudication method for the test set:

• Not applicable. No test set requiring expert adjudication is mentioned for this device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This document pertains to a medical display system, not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. The device is a display system, not an algorithm.

7. The type of ground truth used:

• Not applicable. No ground truth in the context of diagnostic accuracy is used for evaluating this display system. The "ground truth" for a display would refer to objective technical specifications and performance against industry standards.

8. The sample size for the training set:

• Not applicable. This document does not describe the development or training of an AI algorithm.

9. How the ground truth for the training set was established:

• Not applicable. This document does not describe the development or training of an AI algorithm.

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The Coronis 5MP HD display is intended to be used in displaying and viewing digital images for review by trained medical practitioners. It is specifically designed for digital mammography applications.

The Coronis 5MP HD is a diagnostic display

The provided text is a 510(k) summary for the Barco Coronis 5MP HD display system, which is a medical image display intended for digital mammography applications.

Unfortunately, this document does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving those criteria were met.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Data: The document is primarily a regulatory submission summary, focusing on device description, intended use, and substantial equivalence to a predicate device. It explicitly states it's a "510(K) SUMMARY." This type of document, particularly from 2004, typically does not include the detailed test results or acceptance criteria used to validate the device's performance. It confirms regulatory approval based on demonstrating equivalence, not necessarily presenting a full performance study outcome.
• No Mention of a Specific Performance Study: While a manufacturer must perform testing to demonstrate safety and effectiveness for a 510(k) submission, the details of those tests, including specific acceptance criteria or an overarching study proving it met them, are not provided in this public summary. There is no mention of a clinical or technical performance study, sample sizes, ground truth establishment, or expert involvement.
• No AI Component: This device is a display monitor, not an AI or algorithm-based diagnostic tool. Therefore, questions regarding AI-specific aspects like standalone algorithm performance, AI assistance for human readers, or training sets are completely inapplicable.

In summary, the provided text describes a medical display monitor and its 510(k) regulatory clearance, but it does not contain any of the requested information about acceptance criteria or a performance study.

Therefore, I cannot populate the table or answer the specific questions based on the input text.

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