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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.

The provided text is a 510(k) summary and FDA clearance letter for the EKOS NeuroWave Micro-Infusion System. It details the device's description, intended use, and substantial equivalence to predicate devices. However, it does not include specific acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information for the following reasons:

• No Acceptance Criteria or Performance Data: The document states "Electrical safety and system testing confirmed the PT-2B operates as intended with the Micro-Infusion Catheters," but it does not specify what "operates as intended" quantitatively means, nor does it provide any numerical performance metrics (e.g., accuracy, precision, flow rates, efficacy).
• No Clinical Study Details: The document explicitly mentions that "The safety and effectiveness of the EKOS Micro-Infusion System for thrombolytic therapy in the neurovasculature have not been established. Further clinical studies are necessary..." This directly indicates that a study proving clinical effectiveness and safety, which would typically involve acceptance criteria, was not conducted or presented in this 510(k). The clearance is based on substantial equivalence to predicate devices for its stated intended uses, not on a new clinical efficacy study.

Without this missing information, I cannot complete the table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies.

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