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The Symetrex™ Long Term Hemodialysis Catheter is a symmetric tip dual lumen catheter designed for chronic hemodialysis and aphersis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.

The Symetrex™ Long Term Hemodialysis Catheter is a chronic, 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to arochr the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.

The provided document is a 510(k) premarket notification for a medical device called the Symetrex Long Term Hemodialysis Catheter. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, and thus does not contain information about an AI/ML powered medical device. As such, the requested information regarding acceptance criteria, study details, ground truth, and training data for an AI/ML device cannot be extracted.

The document discusses the substantial equivalence of the new device to a predicate device (K140884), focusing on design, materials, manufacturing, and performance testing against established medical device standards (e.g., ISO, ASTM) for safety and basic functionality.

Therefore, I cannot provide the answer in the requested format because the input document does not pertain to an AI/ML medical device.

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