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to provide repeated access to the vascular system. The Ideas' Port allows for the infusion of medications, total parenteral nutrition, blood products, imaging solution, as well as, venous blood sampling.

The Ideas' Dual Port is a totally implantable system designed to provide repeated access to the vascular system. The Ideas' Port allows for the infusion of medications, total parenteral nutrition, blood products, imaging solution, as well as, venous blood sampling. Port access is performed by percutaneous needle insertion using a "Huber type" non-coring needle. The system includes an injection portal with self sealing septum, compression lock and Tecoflex® catheter.

This document, a 510(k) Notification for the Ideas Dual Port, does not contain the detailed information necessary to describe acceptance criteria and a study proving the device meets those criteria in the way you've outlined.

The provided text is a summary for regulatory clearance (510(k)) and focuses on safety, effectiveness, classification, device description, and substantial equivalence to previously marketed devices. It does not include:

• Specific performance metrics: There are no reported device performance values like sensitivity, specificity, accuracy, etc.
• Acceptance criteria: No numerical or qualitative targets are defined for device performance.
• Study design details: No information about sample sizes, data provenance, expert qualifications, ground truth establishment, or specific study types (MRMC, standalone).

The document states: "It meets or surpasses the performance specifications in the guidelines on competitive ports and has superior tensile strength at the junction of the catheter and port." However, it does not specify what those performance specifications are or how "superior tensile strength" was demonstrated (e.g., through a specific test, its methodology, or results).

Therefore, I cannot populate the table and answer the questions based on the provided text.

To answer your request, I would need a detailed study report, a clinical trial summary, or a more comprehensive technical document that outlines the device's performance testing and validation against predefined criteria.

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