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Indications for use for the MediVision Cystoscope are as follows:

MediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. This device is marketed as a reusable device; methods for cleaning, disinfecting, and sterilization are included in latter sections of this submission under Section 5, STERILIZATION INFORMATION.

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I apologize, but the provided text from the FDA 510(k) clearance letter and the "Indications for Use" document does not contain the specific information required to describe acceptance criteria, a study proving device performance, or details about the ground truth, sample sizes, expert qualifications, or adjudication methods.

The documents focus on the regulatory approval for the MediVision Cystoscopes (Models MV400, MV415, MV430, MV470). They state that the device is "substantially equivalent" to previously marketed devices and outline its indications for use (examination of the lower urinary tract and performing diagnostic/therapeutic procedures with accessories).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. This information would typically be found in a separate study report or a more detailed technical submission, not in the FDA clearance letter itself.

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