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The Rotational Angiography Option for Philips MultiDIAGNOST 4 is indicated for use in Angiographic diagnostic imaging examinations.

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The provided text is a 510(k) pre-market notification for the Philips MultiDIAGNOST 4 - Rotational Angiography Option. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines regulatory compliance. It does not contain information regarding acceptance criteria or the study details typically associated with AI/ML device performance evaluation.

Therefore, I cannot extract the requested information as it is not present in the provided document.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Details about experts used for ground truth establishment or their qualifications.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The MultiDIAGNOST 4 is indicated for use in Radiographic/Fluoroscopic, Angiographic, and Interventional diagnostic imaging examinations.

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The provided document is a 510(k) summary for the Philips MultiDIAGNOST 4, Universal Tilt C-Arm System, primarily focusing on its substantial equivalence to predicate devices and regulatory compliance. It does not contain any information regarding acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications in the way typically required for AI/ML-driven medical devices.

Therefore, I cannot provide the requested table and study details. The document is a regulatory approval document for a traditional X-ray system, not an AI/ML device, and thus does not include the type of performance evaluation data you are asking for.

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