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The Five Lumen Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is intended for short-term vascular access.

The Five Lumen Central Venous Catheter is a 10-French radiopaque polyurethane coaxial catheter for short-term use. The catheter is available in lengths of 15 to 30 cm incorporating five round noncommunicating vascular access lumens with numbered, colored-coded hubs.

The provided document is a 510(k) summary for a medical device, the Cook Five Lumen Central Venous Catheter. It describes the device, its intended use, and states that it has undergone testing to provide reasonable assurance of safety and effectiveness.

However, the document does not contain the detailed acceptance criteria and a specific study report proving the device meets those criteria in the format requested. It only broadly states "Testing includes Biocompatibility, Tensile, Vacuum and Pressure, Leakage and Flow Rate." It does not provide:

• A table of specific acceptance criteria values and reported performance values.
• Information on sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details for a diagnostic or AI-enabled device study. This is because the device is a physical medical device (a catheter), not a diagnostic tool or an AI algorithm.

Therefore, I cannot fulfill your request for a table of acceptance criteria and the study that proves the device meets them, nor the other requested details, as this information is not present in the provided text. The document is a regulatory submission for a physical medical product, not a software or AI-driven diagnostic.

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