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Vaxcel ™ PICC with PASV®Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, and piotics, chemotherapy, analgesics, nutitional therapy, and blood products, and blood indicated for blood specimen withdrawal.

The Vaxcel™ PICC with PASV® Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy and blood products. It is also indicated for blood specimen withdrawal.

The provided text is a 510(k) summary for the Vaxcel™ PICC with PASV® Valve Technology. It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria, detailed study designs (such as sample sizes for test or training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance), or the type of ground truth used for a device that relies on interpretation or measurement.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding the study details you requested, as this information is not present in the provided document. The document primarily addresses regulatory aspects of device approval based on substantial equivalence.

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