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The EkoSonic Endovascular System is indicated for the:

• Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
• Infusion of solutions into the pulmonary arteries.
• Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The EkoSonic Endovascular System consists of an EkoSonic Endovascular Device and EKOS Control Unit (Control Unit 4.0 or PT-3B and Connector Interface Cables). The EkoSonic Endovascular Device consists of a single-use, disposable infusion catheter with removable ultrasound core. 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. The Control System generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.

The provided document is a 510(k) premarket notification letter and summary for the Boston Scientific EkoSonic Endovascular Device. This document does not describe an AI/ML-based medical device study. Instead, it's a notification for a medical device (a catheter) with modifications to a previously cleared predicate device.

Therefore, the information requested about acceptance criteria and a study to prove the device meets these criteria in the context of AI/ML performance (e.g., sample size, ground truth, experts, MRMC studies) is not applicable to this document.

The document discusses non-clinical performance data which focuses on physical and biological safety testing for the catheter.

Here's a breakdown of why an AI/ML-focused response is not possible, based on the provided text:

• Device Type: The EkoSonic Endovascular Device is described as a single-use, disposable infusion catheter with a removable ultrasound core, used for infusing fluids into the vasculature. Its function is mechanical and ultrasound-based, not AI/ML-driven.
• Modifications: The changes from the predicate device are listed as: an updated luer design (ISO 80369-7 compliant), a luer material change (Cyrolite® Polymer), and updated packaging and labeling. These are physical modifications, not AI/ML algorithm changes.
• Performance Data: The "Non-Clinical Performance Data" section explicitly states that "Determination of substantial equivalence is based on an assessment of non-clinical performance bench testing, including bench-top performance evaluations and biological safety." It further details "Bench Testing" (physical integrity, functionality, burst pressure) and "Biological Safety Testing" (biocompatibility, bioburden, endotoxin, pyrogenicity, sterility).
• Clinical Testing: The document explicitly states: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of EkoSonic Endovascular Device." This confirms that the approval is not based on a clinical efficacy study often associated with AI/ML device performance.

In summary, there is no AI/ML component described in this FDA submission for the EkoSonic Endovascular Device. Therefore, I cannot provide information on acceptance criteria, test sets, ground truth establishment, MRMC studies, or training sets in the context of AI/ML for this particular device.

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