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The Reprocessed Acunav Diagnostic Ultrasound Catheter is intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients.

The reprocessed device is not indicated for use with pediatric patients.

The Reprocessed AcuNav Diagnostic Ultrasound Catheters distal end has an ultrasound transducer providing 2-D imaging. A steering mechanism controls the image plane orientation through four-way articulation of the tip.

The provided text describes a 510(k) premarket notification for a Reprocessed AcuNav Diagnostic Ultrasound Catheter. This document focuses on demonstrating the substantial equivalence of the reprocessed device to legally marketed predicate devices, rather than establishing acceptance criteria or proving performance of a novel AI/ML-driven device.

Therefore, the information required to answer your questions about acceptance criteria, device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this document.

This document describes a medical device reprocessing process and the testing performed to ensure the reprocessed device's safety and effectiveness are equivalent to new devices. The "Functional and Safety Testing" section highlights the types of tests conducted, but it doesn't provide specific quantitative acceptance criteria or detailed results of those tests.

In summary, this document does not contain the information requested in your prompt regarding acceptance criteria and study results for an AI/ML-driven device.

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