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Single use balloon dilator to be used in conjunction with Olympus endoscopes for dilating strictures of the biliary tree and the major duodenal papilla during endoscopic applications.

The subject device is a single use biliary balloon dilator to be used in conjunction with Olympus endoscopes for dilating strictures of biliary tree and the major duodenal papilla during endoscopic applications.

The subject device is a triple lumen catheter with a balloon mounted to the distal end of the catheter. Balloon dilators are used to exert radial force to dilate narrow duct segments. The balloon at the distal end of the subject device is inserted to the stricture of biliary tree or the major duodenal papilla. And the balloon is inflated by injection of inflation fluid from the balloon lumen hub. The stricture of biliary tree or the major duodenal papilla is dilated by the inflated balloon.

The provided text describes the 510(k) premarket notification for a medical device, the "Single Use Biliary Balloon Dilator" by Olympus Medical Systems Corp. The document primarily focuses on demonstrating substantial equivalence to a predicate device and outlines various non-clinical performance tests.

However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device. The request asks for details like:

• A table of acceptance criteria and reported device performance (in the context of AI/ML metrics like sensitivity, specificity, etc.)
• Sample size used for the test set and data provenance
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study
• Standalone performance
• Type of ground truth (e.g., pathology, outcomes data)
• Sample size for training set and how its ground truth was established

The document describes non-clinical testing for a physical medical device (a balloon dilator), focusing on mechanical and biological properties such as:

• Insertion/withdrawal forces
• Guidewire forces
• Balloon diameter, deflation time, and formation
• Tensile testing
• Burst pressure
• Packaging validation
• Shelf life
• Biocompatibility

These are typical performance tests for a conventional medical device, not an AI/ML diagnostic or prognostic system. The acceptance criteria mentioned are general (e.g., "performs as intended," "in accordance with established in-house acceptance criteria based on ISO 14971:2007").

Therefore, I cannot provide the requested information in the format pertaining to an AI/ML device based on the provided text. The document describes a traditional medical device submission, not one for an AI-powered system where the requested metrics would be relevant.

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