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To allow multiple needleless accesses to an injection vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.

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The provided text is an FDA 510(k) clearance letter for the "FlowArt® Valve for Vial Access". This document does not contain any information about acceptance criteria for an AI/ML device, nor does it describe a study proving such a device meets acceptance criteria.

The 510(k) is for a physical medical device (a valve for vial access), not an AI/ML software device. Therefore, it does not discuss topics such as sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

To answer your request, I would need a different document that pertains to the clearance of an AI/ML driven medical device. The current document is irrelevant to the specific questions asked as it focuses on the substantial equivalence of a physical medical device to a predicate device, and the general regulatory requirements for marketing such a device.

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