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The WIRION® is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION® may be used with commercially available 0.014" guide wires.

WIRION® is a temporary Embolic Protection System (EPS), filtering distal to the intervention site. The system is a rapid exchange, pre-crimped filter that can be used with any commercially available 0.014" guide wires.

I am sorry, but the provided text from the FDA 510(k) K210282 letter and summary for the WIRION® Embolic Protection System does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI-based or statistical classification system.

The document is a traditional 510(k) submission for a physical medical device (an embolic protection system), not a software or AI-driven diagnostic device that would typically involve acceptance criteria related to sensitivity, specificity, or reader studies.

The "Functional and Safety Testing" section mentions:

• Biocompatibility testing
• Simulated use
• Bond and torque strength testing
• Package testing

These are standard engineering and safety tests for a physical medical device, not performance metrics for an AI algorithm.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert involvement, MRMC study details, etc.) from the provided text because it is not relevant to the type of device described in the document.

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