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This medical control unit for endosurgery has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.

The SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 (hereinafter referred to as "UCES-4") has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.

I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted to prove the device meets specific acceptance criteria. The document is an FDA 510(k) premarket notification letter and a 510(k) summary for the SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (UCES-3 Software Version 4) and lists general non-clinical testing performed, such as software validation, electromagnetic compatibility, electrical safety, risk management, and human factors activities, in accordance with various FDA guidances and international standards. However, it does not provide specific acceptance criteria or performance results from these tests in a format that allows for the completion of the requested table and study details.

Therefore, I cannot extract the information required to answer your request.

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