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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 does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is primarily a 510(k) summary and an FDA clearance letter for the EKOS Micro-Infusion System. It details:

• Device Description and Intended Use: The system is for controlled and selective infusion of fluids into peripheral vasculature and regional infusion of contrast materials into selected neurovasculature vessels, not for coronary use.
• Predicate Device: The device is considered substantially equivalent to a previously cleared EKOS Micro-Infusion System (K051225 and K050563).
• Testing: It states that testing and evaluations were performed, and the results support substantial equivalence, but it does not specify what tests were done, what the acceptance criteria for those tests were, or what the reported performance outcomes were.
• FDA Clearance and Limitations: The FDA clearance includes a box warning 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 to ensure that use of devices to deliver thrombolytic therapy into the neurovasculature does not result in an increased incidence of adverse events (e.g., intracranial hemorrhage)." This indicates that for this specific application (thrombolytic therapy in neurovasculature), the device's safety and effectiveness were not fully proven at the time of clearance, and further studies were required.

Therefore, I cannot populate the table or answer most of the questions you've asked because the provided text does not contain that level of detail about performance criteria or studies.

Here's what I can extract based on the limitations of the provided text:

Acceptance Criteria and Device Performance Study

The provided text does not explicitly state specific acceptance criteria or report detailed device performance against such criteria. It broadly mentions "results of the testing and evaluations performed" supporting substantial equivalence to a predicate device, but no quantitative or qualitative performance metrics are given.

The FDA letter, however, imposes a limitation for a specific use case, indicating that for "thrombolytic therapy in the neurovasculature," safety and effectiveness have not been established, and further clinical studies are necessary. This implies that for this particular application, the device did not meet implicit criteria for established safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "testing and evaluations" but not the type or source of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified.

4. Adjudication method for the test set

• Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not mentioned. This document describes a medical device for infusion, not an AI or imaging diagnostic device where MRMC studies are typically performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not mentioned. This document describes a medical device for infusion, not an algorithm.

7. The type of ground truth used

• Not specified.

8. The sample size for the training set

• Not applicable/Not specified. This document is about a hardware device, not a machine learning algorithm with a training set.

9. How the ground truth for the training set was established

• Not applicable/Not specified.

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