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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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