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The Adelante® Breezeway Delivery Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use. Modification and Comparison to Predicate devices. There is no modification to the device itself. The Adelante® Breezeway Delivery Sheath has been cleared in K101497 and will remain intact, and no modifications to product labels.

The provided text is a 510(k) summary for a medical device called the Adelante® Breezeway Delivery Sheath. It describes the device, its intended use, and its substantial equivalence to predicate devices for expanded indications. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI performance, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.

The document explicitly states: "This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use. Modification and Comparison to Predicate devices. There is no modification to the device itself. The Adelante® Breezeway Delivery Sheath has been cleared in K101497 and will remain intact, and no modifications to product labels."

This means the submission focuses solely on expanding the stated uses for a device that was previously cleared (K101497) and has not undergone any changes itself. Therefore, it relies on the previous clearance and the substantial equivalence to existing predicate devices for the expanded indications, rather than new performance studies with specific acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The document does not describe a study involving performance metrics, sample sizes, expert adjudication, or AI.

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