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The Vygon LIFEVAC Dual Lumen PICC Catheters (4.0 Fr. and 5.0 Fr.) are intended for use in patients who require mid-long term I.V. therapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain management or intravenous fluids.

Vygon Double Lumen PICC Catheter 4.0 Fr. & 5.0 Fr.

I apologize, but the provided text from the FDA 510(k) letter for the Vygon Double Lumen PICC Catheter does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

This document is a letter from the FDA confirming that the device is substantially equivalent to legally marketed predicate devices and can proceed to market. It outlines regulatory requirements and general information but does not delve into the specific details of performance studies or acceptance criteria that would typically be found in a more technical submission or a summary of safety and effectiveness.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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