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The Jostra Antegrade Cardioplegia Cannulas are intended to be used to infuse blood and/or cardioplegia solution to the patient's myocardium, antegrade, via the aortic root, during cardiopulmonary bypass for 6 hours or less.

The Jostra Antegrade Cardioplegia Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to infuse blood or cardioplegia solution antegrade via the aortic root during extracorporeal circulation. The cannulas are made from polyurethane (PUR) in sizes 7 Fr., 9Fr., and 11 Fr., with or without vent lines and with an optional needle safety system.

The provided document describes a 510(k) premarket notification for the "Jostra Antegrade Cardioplegia Cannula" (K020515). This application demonstrates substantial equivalence to a predicate device, focusing on performance and biocompatibility. However, it does not describe an AI device or a study that establishes acceptance criteria for such a device.

The information requested in the prompt (acceptance criteria for AI, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is specific to studies evaluating Artificial Intelligence or machine learning systems. The provided text is for a medical device (a cannula), not a software algorithm or AI.

Therefore, I cannot fulfill the request as the input document does not contain information about an AI device or a study demonstrating its performance.

This document pertains to a medical device (cannula) and not an AI or machine learning system. Therefore, the requested information regarding acceptance criteria and studies for an AI device, including details like sample sizes for test/training sets, expert qualifications, MRMC studies, and standalone performance, is not applicable and cannot be extracted from the provided text.

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