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Fogarty Venous Thrombectomy Catheters are indicated for use in the peripheral venous vasculature of adult patients for the removal of emboli and thrombi, and may be used for temporary vessel occlusion.

Fogarty venous thrombectomy catheters are specifically designed for the performance of venous thrombectomy in adult patients. Fogarty venous thrombectomy catheters have a long, soft tip which is intended to facilitate advancement past the venous valves while minimizing trauma. The flexibility required for the venous procedure is supplied by the spring-wound body. The spring is covered with a braiding for additional strength. The gate valve is designed for single-handed operation and to minimize the possibility of leakage. The gate valve has an arrow to indicate the "open" and "closed" positions. There are three available catheter sizes (6 French (2.0 mm), 8 French (2.7 mm), and 8/10 French (2.7/3.3 mm)). Each may be quickly identified by the color-coded body. The size and filling capacity are printed on each catheter.

This document is a 510(k) summary for the Fogarty Venous Thrombectomy Catheter. It outlines the device description, indications for use, and a comparison to a predicate device. Importantly, it focuses on demonstrating substantial equivalence to a preamendment predicate device through bench testing, biocompatibility testing, shelf-life, packaging, and sterilization validations. It does not present a study proving the device meets acceptance criteria related to AI/software performance or human-in-the-loop improvements, nor does it discuss ground truth establishment, expert consensus, or MRMC studies.

Therefore, I cannot extract the information required to answer your prompt because the provided text pertains to a traditional medical device (catheter) and does not contain information about AI, software, or the types of studies you are asking about (e.g., MRMC studies, standalone algorithm performance).

The document explicitly states: "Bench testing inclusive of design verification, packaging, sterilization, and biocompatibility testing all demonstrate that the subject devices are substantially equivalent to the predicate devices." This highlights that the device's performance is demonstrated through physical and biological testing, not through AI/software evaluation.

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