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GORE® PROPATEN® Vascular Graft is intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The GORE® PROPATEN® Vascular Graft is a synthetic graft made of an expanded polytetrafluoroethylene (ePTFE) tube with a reinforcing film for radial strength. The luminal surface of the vascular graft is coated with the CBAS® Heparin Surface.

The provided text describes a 510(k) premarket notification for the GORE® PROPATEN® Vascular Graft. This type of FDA submission is for medical devices and does not involve an AI/ML algorithm. Therefore, the device does not have acceptance criteria, a study proving it meets acceptance criteria, or any of the other AI/ML-specific information requested (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set size, or how training set ground truth was established).

The document details the device, its intended use, predicate devices, and a summary of performance testing conducted to demonstrate substantial equivalence to the predicate device. These tests are physical and material property tests related to the vascular graft's design and manufacturing, not AI/ML performance.

Therefore, I cannot provide the requested information as it is not applicable to the provided document.

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