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The Olympus Integrated Endosurgery System EndoALPHA has been designed to be used with an Olympus endoscope ancillary equipment for central operation, central display, automatic initial setting and interlocking operation of the ancillary equipment.

Olympus EndoAlpha Integrated Endoscopy System is the remote control unit of Olympus legally marketed ancillary equipment. No new clinical functions are added to the above ancillary equipment by the proposed device. This subject device enables the remote control of the ancillary equipment, the display of their action status and the memory of the previous set-up values.

The provided text describes the Olympus Integrated Endoscopy System EndoALPHA, but it does not contain any information about acceptance criteria, device performance metrics, or a study conducted to prove that the device meets specific criteria.

The document is a 510(k) summary from 1998, which primarily focuses on:

• Identification of the device and manufacturer.
• Comparison to predicate devices: It states the device is a remote control unit for legally marketed ancillary equipment and adds no new clinical functions. This is the core of its argument for substantial equivalence.
• Intended Use.
• Technological Characteristics: Emphasizes that "no new clinical functions are added" and therefore "does not affect safety or effectiveness when compared to the predicate devices."
• Non-clinical Tests: Mentions compliance with voluntary safety standards (IEC 60601-1, IEC 60601-2, CISPR 11) and software validation.
• FDA's finding of substantial equivalence.

Because the device is a remote control unit that does not add new clinical functions, the validation appears to be centered around demonstrating electrical safety, material compatibility (no new patient-contacting materials), software validation for the remote control functionality, and adherence to relevant safety standards. There is no mention of clinical performance studies, diagnostic accuracy, or human factor studies in the context of specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document positions the device as substantially equivalent to existing predicate devices due to its lack of new clinical functionality, rather than presenting new performance data against specific clinical criteria.

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