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The theraPORT Low-Profile Vascular Access System is a totally implantable venous access system intended for use with patients that require repeated venous access for injection or infusion therapy and/or venous blood sampling. Because of its low-profile design, it is indicated for either traditional chest placement or placement in the upper arm, and is appropriate for use in pediatric patients and small adults.

The theraPORT® Low-Profile Vascular Access System is a totally implantable venous access system consisting of a detached catheter and port.

The provided text describes the theraPORT® Low-Profile Vascular Access System, a medical device, and its regulatory submission. It does not contain information about acceptance criteria for an AI/CAD/software device, nor does it detail a study proving such a device meets acceptance criteria. The document is a 510(k) summary for a physical implanted medical device.

Therefore, I cannot provide the requested information. The document explicitly states: "Clinical studies were not conducted as they were determined to be not necessary due to the similarity in design, performance, materials, function and intended use of the theraPORT® Low-Profile Vascular Access System to other commercially available systems."

The "Performance Testing" section describes mechanical tests of the physical device rather than a study of an AI/CAD/software system. These tests are:

• Catheter-to-port connection strength tests
• Septum puncture durability tests
• Port leakage integrity tests
• Port/catheter clearance tests

These are not relevant to the performance metrics typically associated with AI/CAD systems (e.g., sensitivity, specificity, AUC).

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