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The AngioDynamics, Inc. Morpheus® CT PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. For blood sampling, infusion, or therapy use a 4 French or larger catheter.

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I am sorry, but based on the limited information provided in the document, I cannot answer questions 1-9. This document is a letter from the FDA regarding 510(k) clearance for a medical device (AngioDynamics, Inc. 5F Dual Lumen Morpheus® CT PICC and Procedure Kit). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

However, the document does not contain any information about:

• Acceptance criteria for device performance.
• Studies conducted to prove the device meets performance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Ground truth adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• The type of ground truth used.
• How ground truth for the training set was established.

This type of information is typically found in the 510(k) premarket notification itself, or in supporting study reports, which are not part of this FDA clearance letter.

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The AngioDynamics, Inc. Morpheus® CT PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injections of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

Not Found

I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, or any study results. The document is an FDA 510(k) clearance letter for the AngioDynamics, Inc. Morpheus® CT PICC and Procedure Kit, indicating that the device has been found substantially equivalent to legally marketed predicate devices. It outlines the indications for use but does not present data from studies or specific performance metrics.

Ask a specific question about this device