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The GORE® PROPATEN® Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering from 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 document is a 510(k) premarket notification letter from the FDA for a vascular graft. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document only discusses substantial equivalence to a predicate device based on similar technology, manufacturing, coating, sterilization, and intended use, with a minor update to the end-of-shelf-life Heparin Surface Activity specification.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a training set from this document.

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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.

Ask a specific question about this device