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The PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter is intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system.

The PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a PowerLoc® Safety Infusion Set (SIS), the PowerPort® device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.

The PowerPort® ClearVUE® Slim with 8F Polyurethane Catheter is a member of the PowerPort® series of power-injectable implanted ports. The subject device consists of a hard plastic port and 8F polyurethane catheter that is attached to the port with a catheter lock compression fitting. The subject device is distinguishable as a member of BAS's power-injectable port series by the triangular body shape and three palpation bumps on the septum.

PowerPort® implanted ports can be used for routine vascular access using a non-coring access needle. However, for power injection procedures, PowerPort® ports must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to create a power-injectable system.

The provided text does not describe a study involving an AI/CAD/ML device. Instead, it is a 510(k) summary for the PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter, a medical device designed for vascular access.

Therefore, I cannot provide information on acceptance criteria, test set details, expert ground truth, MRMC studies, standalone performance, training set size, or training set ground truth, as these concepts are not applicable to the type of device described in the document.

The document discusses Verification testing performed in accordance with Design Controls per 21 CFR §820.30 and various guidance documents and standards to determine appropriate methods for evaluating the performance of the device. It states:

"The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device."

This indicates that the acceptance criteria are based on established standards and general device performance, not on AI-related metrics.

In summary, the provided information does not pertain to an AI device, and thus the requested specific details regarding AI device performance evaluation are not available in the given text.

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