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The Smart Port® CT Port Access System is indicated for any patient requiring repeated access of the vasculature system, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood.

When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19 Ga sizes, the Smart Port® CT Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.

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I am sorry, but based on the provided document, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for a medical device (AngioDynamics, Inc. Smart Port® CT, Mp and LP Lines Extensions).

This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance. It does not contain information about the specific acceptance criteria, study details, performance metrics, ground truth establishment, or sample sizes that you have requested.

The document focuses on:

• The device name and its regulatory classification.
• The FDA's determination of substantial equivalence.
• General regulatory requirements for the manufacturer.
• The intended indications for use of the device.

To provide the information you're looking for, I would need access to the actual 510(k) submission, specifically the sections detailing the performance testing and clinical data (if any was required for this particular type of device clearance). This document explicitly states, "CDRH does not evaluate information related to contract liability warranties," and the core of its content is the regulatory clearance, not a detailed technical or clinical study report.

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