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Indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. The recommended application is printed on the package label referring to any combination of esophageal, pyloric and colonic dilatation.

The proposed CRE™ Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. It is designed to pass through the working channel of an endoscope and accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 in (0.89 mm), floppy tip guidewire preloaded in the guidewire lumen. The guidewire is 25 cm longer than the balloon catheter with the excess length extending from the hub end of the catheter. A guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in the "OFF" or unlocked position. The guidewire may only be advanced or removed from the catheter when the switch on the locking device is in the "OFF" position. The guidewire may be held in place within the catheter by moving the switch to the "ON" position.

The provided text is a 510(k) summary for the Boston Scientific CRE™ Balloon Dilation Catheter. This document is a premarket notification for a medical device and does not contain information regarding software-based AI/ML device performance or clinical study details as requested.

The document focuses on demonstrating substantial equivalence to a predicate device (K974788 CRE™ Balloon Dilatation Catheter) through technological characteristics, materials, manufacturing processes, and in-vitro testing.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance in a clinical study, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

The document explicitly states:

• "In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." (Section 7. Performance Data)

This indicates that any performance data mentioned in this specific submission is based on bench testing (in-vitro), not human clinical studies. The submission's purpose is to demonstrate substantial equivalence, not to detail a complex clinical performance study for a novel AI/ML device.

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