Search Results

This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.

The MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula models feature wire wound polyvinyl chloride (PVC) bodies with side ports in the distal tip, a ported atrial basket drainage site located along the length of the cannula body, and a 3/8-inch (0.95 cm) to 1/2-inch (1.27 cm) connection site. The overall length of each cannula body is approximately 15¼ inch (38.7 cm). Insertion depth marks are provided to aid in positioning of the cannula. Each cannula is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide.

This document is a 510(k) clearance letter for a medical device: the MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula. It does not contain any information about an AI/ML-driven medical device, nor does it discuss acceptance criteria, test sets, ground truth establishment, or human reader studies related to AI performance.

The clearance is for a physical device used in cardiopulmonary bypass surgery, and the summary of performance data refers to pre-clinical bench testing related to material formulation changes, not algorithmic performance.

Therefore, I cannot provide the requested information based on the provided text. The prompt asks for details about AI/ML device performance, which are entirely absent from this 510(k) clearance.

Ask a specific question about this device