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The CLISIS SYSTEMS, Discovery RF180 is indicated for performing general radiography, fluoroscopy and angiography procedures.

Applications and techniques:

• Gastroenterology
• Skeleton
• Thorax and lungs
• Paediatrics
• Urology and gynecology
• Emergency/traumatology
• Digital angiography
• Linear tomography
• Auto Image Paste (Stitching)
• Tomosynthesis

Not Found

The provided text is an FDA 510(k) clearance letter for the CLISIS SYSTEMS, Discovery RF180, a tomographic x-ray system. It states the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.

However, the provided text DOES NOT contain any information regarding acceptance criteria or the study that proves the device meets those criteria. It is a regulatory clearance document, not a detailed technical report or clinical study summary.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance
7. Type of ground truth used
8. Training set sample size
9. How ground truth for the training set was established

The document focuses on the regulatory approval process and the intended uses of the device, not the technical details of its performance or the studies conducted to validate that performance. To obtain that information, one would typically need to refer to separate study reports, a detailed 510(k) summary (if available publicly with more technical details), or an Instructions for Use (IFU) document if it contains performance specifications.

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The MECALL CLISIS SYSTEMS, Discovery RF180 is indicated for performing general radiography, fluoroscopy and angiography procedures/applications.

The device is intended for use in:

• Skeleton
• Chest and lungs
• Pediatrics
• Emergency/traumatology
• Gastroenterology
• Urology and gynecology
• Linear tomography
• Digital angiography
• Stitching

Not Found

The provided document is a 510(k) summary for a fluoroscopic x-ray system, the MECALL CLISIS SYSTEMS, Discovery RF180. It states the indications for use but does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth, expert adjudication, or sample sizes for training or testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about any of the other requested study details based on this document. This document is a regulatory clearance letter, not a detailed study report.

Ask a specific question about this device