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The EkoSonic™ Endovascular System with Rapid Pulse Modulation is intended for the infusion of solutions into the pulmonary arteries.

The safety and effectiveness of the EKOS EkoSonic™ Endovascular System with Rapid Pulse Modulation for thrombolytic therapy administration in pulmonary embolus have not been established. In particular, the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic, nor has it been cleared with an indication for thrombolysis in pulmonary emboli.

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

The system consists of a disposable infusion catheter with removable ultrasound core and an instrument that generates and controls the delivery of energy to the catheter. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature.

This document is a 510(k) premarket notification for the EkoSonic™ Endovascular System with Rapid Pulse Modulation. It does not describe a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/ML medical device would. Instead, it describes a "Special 510(k)" notification, which generally means changes have been made to a previously cleared device, and the submission argues that these changes do not affect the technological characteristics or safety and effectiveness, thus maintaining substantial equivalence to a predicate device.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not applicable in the context of this specific regulatory submission. The document explicitly states: "The 510(k) submission was not re-reviewed." and "The device modification described in this notification does not affect the technological characteristics for the EkoSonic System."

However, based on the Test Summary provided, I can infer some general information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Implicitly, the acceptance criteria are that the modified device's electrical safety, electrical circuit qualification, software validation, and system integration demonstrate performance equivalent to the predicate device. The document does not provide quantifiable metrics or specific thresholds for these criteria.
• Reported Device Performance: The document states that "Electrical safety testing, electrical circuit qualification testing, software validation testing and system integration testing confirmed the modified EkoSonic System is substantially equivalent to the predicate EndoWave System." No specific performance data (e.g., accuracy, sensitivity, specificity, or detailed electrical safety measurements) is provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable. The "Test Summary" refers to engineering and software validation tests, not a clinical test set with patient data.
• Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. This is not a clinical study involving expert interpretation of medical data. The "tests" mentioned are technical in nature.

4. Adjudication Method for the Test Set:

• Not applicable.

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 applicable. This device is not an AI/ML diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This is not an algorithm for diagnostic performance.

7. The Type of Ground Truth Used:

• For the technical tests mentioned (electrical safety, etc.), the "ground truth" would be the engineering specifications, regulatory standards, and expected behavior established for the device and its predicate. No external medical ground truth (like pathology or outcomes data) is referenced in this summary.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device involving a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable.

In summary:

This document is a regulatory submission focused on demonstrating substantial equivalence for a modified medical device, not a performance study for a new device, especially not an AI/ML-driven one. The "tests" mentioned are related to engineering and software validation to ensure the modified device functions as intended and safely, maintaining equivalence to its predicate. It explicitly states that "The safety and effectiveness of the EKOS EkoSonic™ Endovascular System with Rapid Pulse Modulation for thrombolytic therapy administration in pulmonary embolus have not been established." and "the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic, nor has it been cleared with an indication for thrombolysis in pulmonary emboli."

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