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to enable clinicians to withdraw quantities of solution multiple times from vials without the need for needles.

Multi-Dose Vial Adapter & Bionector

The provided text is a U.S. FDA 510(k) clearance letter for the VYGON Multi-Dose Vial Adapter & Bionector. This type of document does not contain details about acceptance criteria, study design, or specific performance metrics of the device itself.

The letter is a regulatory approval, stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements, but not the technical data that would be used to establish acceptance criteria or prove performance.

Therefore, I cannot provide the requested information based on the input text. The information points you've asked for (acceptance criteria table, sample sizes, ground truth, expert qualifications, etc.) are typically found in the 510(k) submission summary or detailed study reports, which are not part of this clearance letter.

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