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

The GORE® ACUSEAL 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) clearance letter from the FDA for a medical device called the GORE® ACUSEAL Vascular Graft. This type of document establishes substantial equivalence to a predicate device and does not contain the detailed study information typically found in a clinical trial report or an academic paper describing device performance against explicit acceptance criteria.

Specifically, the document states:

• "One in vitro study was conducted to demonstrate substantial equivalence to the predicate device."
• "The GORE® ACUSEAL Vascular Graft is substantially equivalent to the predicate device. The change to the end-of-shelf-life Heparin Surface Activity specification does not raise new types of safety or effectiveness questions, and the testing provided in this application supports a determination of substantial equivalence."

Therefore, the document does not provide the information requested regarding acceptance criteria and the detailed study that proves the device meets them because it's a 510(k) clearance based on substantial equivalence, not a performance study against predefined criteria.

The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria or conducting extensive clinical trials, especially for Class II devices like this vascular graft.

As a result, I cannot fill in the requested table and details about the study because that information is not present in the provided FDA clearance letter.

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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.

Ask a specific question about this device