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Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic devices into the vasculature, excluding coronary and neuro vasculature.

The Flexor® Tuohy-Borst Side-Arm Introducer Ansel Modification, Flexor® Check-Flo® Introducer Ansel Modification, Flexor® Check-Flo® Introducers Ansel Modification with High-Flex Dilator and Hydrophilic Coating, Flexor® Check-Flo® Introducer Balkin Up and Over® Contralateral Design, Flexor® Up and Over® Balkin Contralateral Introducer, Flexor® Check-Flo® Introducer Raabe Modification and Flexor® Check-Flo® Performer Introducer are composed of an introducer sheath and a dilator(s). These devices are intended to be used as introducer sheaths, providing means of introducing therapeutic or diagnostic devices into the vasculature.

This document is a 510(k) Premarket Notification from the FDA regarding several Cook Inc. medical devices, specifically various configurations of their "Flexor" Introducers and Guiding Sheaths. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and performance testing.

The document does NOT describe the acceptance criteria or a study related to a device that uses AI or sophisticated algorithms or image processing where ground truth, number of experts, reader studies, or training/test sets would be relevant.

Instead, the listed "Test Data" refers to standard medical device performance testing for physical and biological characteristics, such as:

• Biocompatibility testing
• Coating integrity testing
• Dilator and introducer sheath tensile testing
• Dilator and introducer sheath liquid leakage
• Dilator and introducer sheath mechanical abrasion
• Dimensional verification
• Introducer sheath lubricity
• Thromboresistance testing
• Torque strength
• Acute Performance Testing

These tests confirm the physical and material properties of the catheter introducers meet predetermined acceptance criteria, which are typically defined by engineering specifications and relevant ISO standards (e.g., ISO 10993-1:2009 for biocompatibility, BS EN ISO 11070:1999 for introducer sheaths).

Therefore, it is not possible to extract the requested information (AI/algorithm-related acceptance criteria, test set, ground truth, expert opinions, MRMC studies, etc.) from this document. The document concerns a traditional Class II medical device, not one involving AI or diagnostic imaging interpretation.

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