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Olympus MH-246R Balloon Sheath have been designed to be used with the Olympus Ultrasonic Probe UM-2R/UM-3R, for intraluminal ultrasonic imaging of the urinary tract.

The MH-246R Balloon Sheath for urinary tract consists of two sections - insertion section and connector section. The insertion section is constructed of a balloon with the light shielding cover, insertion tube, and adapter. The connector section consists of a connector body, probe locking ring, sheath locking ring, and irrigation port. The insertion section is connector body through a sheath locking ring, while the ultrasonic probe in inserted into the balloon sheath through a probe locking ring. The water filled syringe is connected to the irrigation port via an extension tube and three-way stopcock. The insertion section with the balloon will be provided sterile and intended for single use only. The connector section can be reused after proper cleaning and sterilization as outlined in the instruction manual.

The provided text is a 510(k) Summary for the Olympus MH-246R Balloon Sheath. It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics (such as accuracy, sensitivity, specificity), study design, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested table or detailed answers to questions 1-9 based on the given input. The document is primarily a regulatory submission outlining the device's description and intended use for substantial equivalence, not a performance study report.

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