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The Nexus I.V. Vial Access Device is intended for use to aid healthcare professionals in mixing and transferring I.V. fluids / medication from a rubber-stopper medication vial to another device, through a needle-free system that aids in the elimination of needle stick injuries.

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The provided document is a 510(k) clearance letter from the FDA for a medical device. It does not contain any information about the acceptance criteria or a study that proves the device meets those criteria.

The letter states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer (Nexus Medical, LLC) in their 510(k) submission, which would include performance data, but that specific data and the acceptance criteria themselves are not detailed in this clearance letter.

Therefore, I cannot answer your request for a table of acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth information based on the provided text.

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