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The EKOS Micro-Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The EKOS Micro- Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.

The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor and a distal end hole for placement over a guide wire and fluid infusion.

This document is a 510(k) notification for a medical device called the EKOS Micro-Infusion System. It is a submission to the FDA requesting clearance to market the device, demonstrating its substantial equivalence to previously cleared devices. It is not a study reporting on the performance of an AI/ML device.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, or MRMC studies for an AI/ML device.

The document describes a medical device (a catheter system), its intended use, technological characteristics, and its comparison to predicate devices, primarily focusing on hardware and safety/equivalence as per regulatory requirements for a 510(k) submission. It does not involve AI or algorithms that would have performance metrics like sensitivity, specificity, or AUC, established by expert consensus or pathology, which are typically found in studies for AI/ML diagnostic or predictive devices.

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