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The PercSys Accordion® Stone Management Device is intended to be used in endoscopic procedures to bypass, entrap and remove calculi and other foreign objects from the urinary tract, to prevent retrograde migration of calculi during lithotripsy, and to guide instrumentation within the ureter.

The Accordion device consists of a film membrane preloaded onto a two-part wire guide with a removable handle. The device is advanced within the urinary system similar to a wire guide, then, once the film membrane is in the desired position, the film folds into a helical coil (a film-based occlusion) which occupies the lumen of the anatomy in which it resides. In this manner, the occlusion limits migration of stones and stone fragments during lithotripsy. The shaft of the device is 0.97mm (0.038 inch) in outer diameter, has a 150 cm working length, and the film occlusion can be formed into either a 7 mm or 10 mm diameter helical coil. The device is visible under fluoroscopic imaging due to marker bands on either side of the film component and radiopaque disc embedded in the film. The Accordion device is provided sterile and is a single-use only device.

The provided text is a 510(k) summary for a medical device (PercSys Accordion® Stone Management Device) and details its intended use, description, and substantial equivalence to predicate devices. It does not contain information about specific acceptance criteria, device performance metrics, or details of a study that explicitly proves the device meets such criteria.

The document states: "Bench top and clinical data from the literature were submitted in support of the proposed performance claims for this 510(k) submission, as well as in support of documenting that the changes in device materials and sterilization method has not affected design specifications." and "The bench top and clinical data show the Accordion device is as safe and as effective as the predicate devices and support the proposed advertising claims."

However, it does not provide the details of this data, making it impossible to answer the specific questions regarding acceptance criteria, sample sizes, ground truth establishment, or clinical study methodologies.

Therefore, I cannot populate the table or answer the specific questions as the required information is not present in the provided text.

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