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The PowerPort™ Implanted Port 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, 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.

PowerPort™ duo M.R.I.™ Implanted Port with 9.5 Fr. D/L ChronoFlex® Polyurethane Catheter devices are implanted vascular access devices designed to provide long-term, repeated access to the vascular system.

The provided text is a 510(k) Summary for a medical device (PowerPort™ duo M.R.I.™ Implanted Port with 9.5 Fr. Dual Lumen ChronoFlex® Polyurethane Catheter). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on:

• Indications for Use: The current device has the same intended use as the predicate devices (PowerPort™ M.R.I.™ Implanted Port with 8.0 Fr. ChronoFlex® Polyurethane Catheter and X-Port™ duo Implanted Port with 9.5 Fr. D/L ChronoFlex® Polyurethane Catheter).
• Technological Characteristics: The summary states "Technological similarities between the subject PowerPort™ duo M.R.I.™ Implanted Port... and the cited predicate devices remain identical." It also claims "no additional questions raised regarding safety or effectiveness."
• Safety and Performance Testing: The summary broadly states that "safety and performance testing" was conducted, and the device "meets the minimum requirements that are considered adequate for its intended use." However, it does not provide any specific acceptance criteria, test results, or details about the studies performed.

Therefore, I cannot populate the table or answer the specific questions about the study design, sample size, ground truth, or expert involvement, as this information is not present in the provided document.

The document is a regulatory submission demonstrating substantial equivalence to predicate devices, which often relies on a comparison of design, materials, manufacturing processes, and sometimes bench testing, rather than extensive clinical studies with specific performance metrics and acceptance criteria for AI/diagnostic devices.

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