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The 1.9F Vascu-PICC® is a long term catheter intended for central venous access via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.

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The provided text is an FDA 510(k) clearance letter for the 1.9F Vascu-PICC. This document does not include information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the manner you've described for, for example, an AI/ML device.

Therefore, I cannot extract the requested information (acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) from this document. The document primarily confirms regulatory clearance based on substantial equivalence to pre-existing devices.

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