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

Single use balloon dilator Maxpass ™ is a triple lumen catheter with a balloon Single use banoon and of the catheter. Balloon dilators are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.

The provided text describes a medical device, the "Single use balloon dilator MaxPass™", and its FDA 510(k) summary. However, it does not contain any information regarding acceptance criteria, reported device performance data, sample sizes, expert qualifications, adjudication methods, details of a multi-reader multi-case study, standalone performance, or ground truth establishment.

The document primarily focuses on:

• Administrative details: Submitter information, contact person, device name, classification, and predicate devices.
• Device description: A brief overview of the device (triple lumen catheter with a balloon).
• Intended use: For dilating strictures of the biliary tree and major papilla.
• Summary of non-clinical tests: States that when compared to predicate devices, there are no significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness. This is a very general statement and does not provide specific performance data.
• FDA correspondence: An FDA letter confirming substantial equivalence to predicate devices based on the information provided in the 510(k) submission.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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