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The Occlusion Perfusion Catheter™ is indicated for localized infusion of various diagnostic and therapeutic agents into the peripheral vasculature. The Occlusion Perfusion Catheter™ may be repositioned for multiple treatments with the same patient. It is not indicated for use in the neurovasculature.

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I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a device called "Occlusion Perfusion Catheter™", along with its indications for use. It primarily discusses regulatory aspects and does not delve into detailed performance studies or statistical evidence.

Therefore, I cannot provide the requested information in the specified format.

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The Occlusion Perfusion Catheter™ is indicated for localized infusion of various diagnostic and therapeutic agents into the peripheral vasculature. It is not indicated for use in the neurovasculature.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Occlusion Perfusion Catheter™" does not contain the detailed information necessary to answer your request regarding acceptance criteria and the study that proves the device meets those criteria.

The document primarily focuses on the FDA's determination of substantial equivalence to a predicate device, the regulatory class, product code, and general regulatory requirements. It includes the device name and its Indications for Use.

It does not include:

• A table of acceptance criteria and reported device performance.
• Details about specific studies, sample sizes, data provenance, ground truth establishment, or expert qualifications.
• Information about MRMC studies or standalone algorithm performance.

To find this type of information, you would typically need to review the original 510(k) submission itself, which includes the detailed testing and performance data submitted by the manufacturer to the FDA. The letter provided is merely the FDA's official response to that submission.

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The Occlusion Perfusion Catheter 10 is indicated for localized infusion or irrigation of various diagnostic and therapeutic agents into the peripheral vasculature. It is not indicated for use in the neurovasculature.

Not Found

This looks like a 510(k) clearance letter for a medical device (Occlusion Perfusion Catheter), not a study report or a document detailing acceptance criteria and device performance in the context of an AI/algorithm.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) from the provided text. These details are typically found in a clinical study report, a pre-submission document, or a detailed technical report that supports the 510(k) application, not in the FDA clearance letter itself.

The provided document only states that the device is "substantially equivalent" to legally marketed predicate devices and outlines the indications for use. It does not contain any information about performance testing against specific acceptance criteria for an AI or algorithm.

Ask a specific question about this device