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Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. Stopcocks are intended for use to change the direction of fluids through a tubing set. Needleless valve allows the user to add medication into the without the use of a needle.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Flowart" and does not contain the detailed information you requested about acceptance criteria and the study proving the device meets them.

The document primarily focuses on:

• The FDA's determination of substantial equivalence to a predicate device.
• Regulatory requirements and guidelines for the manufacturer.
• The indications for use of the Flowart device (extension sets, stopcocks, needleless valve).

It does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Information on data provenance, expert qualifications, or adjudication methods.
• Details about MRMC studies, effect sizes, or standalone algorithm performance.
• The type and establishment of ground truth.

Therefore, I cannot fulfill your request with the information provided.

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