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GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access. The GORE® ACUSEAL Vascular Graft is a multi-layer vascular graft with a low bleed layer between the inner and outer layers of ePTFE (expanded polytetrafluoroethylene). The luminal surface of the inner graft component is coated with the CBAS® Heparin Surface.

This document is a 510(k) Summary for the GORE® ACUSEAL Vascular Graft. It describes a medical device and its regulatory review, not an AI/ML powered device. Therefore, the request to describe acceptance criteria and associated studies for an AI/ML powered device cannot be fulfilled.

The document states that the GORE® ACUSEAL Vascular Graft has the same clinical use, indications for use, fundamental technology, materials, sterilization, and intended use as its predicate device (K130215, GORE® ACUSEAL Vascular Graft). The only differences are an additional packaging configuration and additional device configurations with different diameters.

The performance testing summarized relates to the physical and material properties of the vascular graft itself, not to the performance of an AI/ML algorithm.

Therefore, since the input document does not pertain to an AI/ML powered device, I cannot provide the requested information regarding AI/ML acceptance criteria, study details, ground truth establishment, or sample sizes for AI/ML models.

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