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Cannulation of the Papilla of Vater to deliver contrast medium for fluoroscopic visualization of the biliary/pancreatic system.

The ProFormaTM HF 4.5 Cannula is used for endoscopic cannulation of the biliary ductal system. With a tapered, atraumatic tip, and high flow injection port, this device provides cannulation of the papilla and access into the biliary system. The 4.5 French tip accepts a 0.035" (0.889 mm) guidewire. The unique multi-lumen port design at the proximal end, allows for injection of contrast medium through two lumens with a separate port for guidewire passage.

Colored visual markers located on the distal tip endoscopically aid in the assessment of cannulation and insertion into the biliary system. A distal radiopaque maker band aids in fluoroscopic visualization. A proximal marker band indicates when the catheter exists the duodenoscope.

The provided K050777 document does not contain information about a study proving device performance against acceptance criteria for an AI/ML powered device.

This document describes a 510(k) submission for a medical device called the "ProForma™ HF 4.5 Cannula," which is used for endoscopic cannulation of the biliary ductal system. The submission is from 2005, significantly predating the widespread use and regulatory framework for AI/ML in medical devices.

Therefore, I cannot fulfill your request for information related to acceptance criteria and a study proving an AI/ML device meets them based on this document. The document focuses on establishing substantial equivalence for a physical medical device based on its technological characteristics, biocompatibility, and functionality testing, not on the performance of a software algorithm.

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