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The Vygon LIFECATH-PICC (PUR) Catheter is intended for use in patients who require mid-long term I.V. therapy. It may be used to administer hyperalimentation, chemotherapy, pain management or intravenous fluids.

Vygon LIFECATH-PICC (PUR) Catheters & Single and Double Lumen, 3 FR, 4 FR, 4.5 FR, and 5 FR)

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) premarket notification for a medical device (Vygon Lifecath-PICC Catheters). It contains an FDA letter of substantial equivalence, an indications for use statement, and contact information.

However, the document does not contain any information about acceptance criteria for device performance, or any studies conducted to prove the device meets such criteria. It's a regulatory approval document, not a detailed performance study report. Therefore, I cannot extract the table of acceptance criteria, sample sizes, expert qualifications, or details about comparative effectiveness studies, as this information is not present.

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