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The Total Abscession Biliary Drainage Catheter is indicated for percutaneous transhepatic biliary drainage.

The Total Abscession Biliary Drainage Catheters includes a variety of related components including:

• Total Abscession Biliary Drainage Catheter .
• . Stiffening Cannula
• Flexible Cannula .
• Standard Injection Port ●
• Needless Injection Port ●
  The Total Abscession Biliary Drainage Catheter family includes 8F, 10F, 12F, and 14F catheters in working lengths of 40cm. The Total Abscession Biliary Drainage Catheter are used to percutaneously drain fluids from the biliary tree.

The provided document is a 510(k) premarket notification for a medical device, specifically the AngioDynamics Total Abscession Biliary Drainage Catheter. It outlines the regulatory approval process and describes the device, its intended use, and comparative testing against a predicate device.

However, the document does not contain any information about a study involving AI, image analysis, computer vision, or machine learning. It focuses on the physical properties and performance of a catheter, specifically material formulation changes and mechanical tests.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria, as the input document does not describe such a device or study.

To answer your request, I would need a document detailing an AI-powered medical device and its validation studies.

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The ANGIODYNAMICS Total Abscession Biliary Drainage Catheter is indicated for percutaneous transhepatic biliary drainage.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (ANGIODYNAMICS Total Abscession Biliary Drainage Catheter). It primarily concerns the regulatory approval based on substantial equivalence to a predicate device and states the indications for use.

This document does not contain any information about:

• Acceptance criteria and reported device performance.
• Details of any study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for this specific input.

Ask a specific question about this device