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The HEMASHIELD PLATINUM™ Vascular Graft is indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

The Hemashield Platinum WDV grafts are woven double velour vascular grafts impregnated with a highly purified collagen. The Hemashield Platinum WDV grafts minimize bleeding at implant and thereby eliminate the operative preclotting step, including cumbersome autoclave techniques. The collagen is gradually resorbed by the patient. The CONCENTRICRIMP® pleat and GUIDELINE® are also featured. In addition to collagen, the graft also contains glycerol as a softening agent.

The provided document describes a 510(k) premarket notification for a medical device called the "Hemashield Platinum Woven Double Velour TAAA graft configuration." This is a vascular graft used for the replacement or repair of arteries.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a submission for substantial equivalence, comparing the new device to existing predicate devices.

Specifically, the document states:

• "The Hemashield Platinum WDV TAAA configuration has been tested and compared to the predicate devices. All data gathered demonstrate this device is substantially equivalent. No new issues of safety or efficacy have been raised."
• "We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule..."

Since this is a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a de novo study with defined performance metrics in the way a PMA might. The biocompatibility section mentions ISO 10993 testing, which implies testing was done but doesn't detail the acceptance criteria or results.

Therefore, I cannot fulfill the request to provide acceptance criteria and study details based on this document. The information requested (sample size, data provenance, number of experts, adjudication, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for the training set) are typically found in clinical study reports or more detailed verification and validation documents, which are not present in this summary.

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