Search Results

The Alien™ RX Micro Cannula is indicated for use to cannulate and inject contrast media into the biliary and pancreatic ductal systems. Contrast medium is injected through the cannula and fluoroscopy or x-ray is performed to obtain a cholangiogram.

The proposed Alien™ RX Micro Cannula is a single lumen cannula. It is compatible with the Boston Scientific Microvasive Endoscopy's Rapid Exchange™ platform, and is capable of accommodating a .025" guidewire while passing through a .035" lumen.

The provided FDA document is a 510(k) premarket notification for the "Alien™ RX Micro Cannula." This type of document is for a medical device and describes its intended use and a comparison to a predicate device to establish substantial equivalence. It is not a study report investigating an AI/ML powered device, nor does it contain information about "acceptance criteria" and "device performance" in the way a clinical study or a study validating an AI model would.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these details are not present in the provided text.

The document primarily focuses on:

• Device Name: Alien™ RX Micro Cannula
• Intended Use: To cannulate and inject contrast media into the biliary and pancreatic ductal systems for cholangiography.
• Predicate Device: Contour™ ERCP Cannula (K833417)
• Substantial Equivalence: The document asserts that the Alien™ RX Micro Cannula is substantially equivalent to the predicate device in terms of performance characteristics and biocompatibility.

No information regarding AI/ML models, their performance, or associated validation studies is present in this document.

Ask a specific question about this device