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These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

The EOPA 3D® Arterial Cannula consists of a flexible, thin wall, wirewound body with a tapered distal tip. The tip features depth markings and an adjustable radiopaque suture ring to indicate insertion depth. The proximal end of the cannula terminates in a vented or non-vented connector. An obturator is provided to facilitate cannula insertion and priming. Multiple depth markings, catalog code, and French size are printed on the cannula body. The EOPA 3D® Arterial Cannula is sterile, nonpyrogenic, and single use.

This document describes a 510(k) premarket notification for the "EOPA 3D Arterial Cannula". However, there is no information within the provided text about acceptance criteria for a study demonstrating device performance against specific metrics, nor details about a study that proves the device meets such criteria.

The document outlines a comparison to a predicate device (the EOPA 3D Arterial Cannula), indicating that the proposed device is substantially equivalent due to similar intended use, design, materials (with a specific material formulation change for the Luer Cap), principles of operation, and technology.

The "Summary of Testing" section lists various tests performed on the Luer Cap with an alternate material formulation. These are primarily verification/validation tests for the cap itself, not a study assessing the overall device's clinical performance or a comparative effectiveness study with human readers.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device based on material and component-level testing rather than presenting a performance study with acceptance criteria.

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