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The Next Generation Access Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Next Generation Access Platform consists of the Next Generation Access Sheath, Dilator, Introducer Sheath, Rotating Hemostasis Valve (RHV), and Hemostasis Valve Adapter (HVA). The Next Generation Access Sheath is a single lumen, braid-reinforced, variable stiffness sheath with a radiopaque zone on the distal end and a luer hub on the proximal end. The Next Generation Access Sheath is compatible with introducer sheaths appropriately sized for the outer diameter of the Next Generation Access Sheath. The Next Generation Access Platform is provided sterile, non-pyrogenic, and is intended for single use only. The Dilator facilitates the percutaneous entry of the Next Generation Access Sheath by forming an atraumatic transition of the Next Generation Access Sheath through the skin and subcutaneous tissue to the vessel. The distal 40 cm portion of the Next Generation Access Sheath is covered with a hydrophilic coating to aid in reducing friction.

The provided text describes the regulatory clearance for the "Next Generation Access Platform" and includes performance data from bench tests, but it does not include information about AI/ML algorithm performance, ground truth, or study designs typically associated with AI/ML evaluations. Therefore, I cannot generate a response that directly addresses acceptance criteria and studies for an AI device.

It explicitly states:
"No animal study was conducted because bench performance testing was deemed sufficient for verification and validation and to support substantial equivalence."
"No clinical study was conducted because bench performance testing was deemed sufficient for verification and validation and to support substantial equivalence."

The available information pertains to a conventional medical device (a catheter platform) and its physical and biological performance characteristics, not an AI/ML device.

However, if you would like me to summarize the performance data for this conventional medical device based on the provided text, I can do that. Please clarify if that is what you would like.

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