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This instrument has been designed to be used with an Olympus universal endoscopic ultrasound center or a diagnostic ultrasound system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment. This instrument is designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

OLYMPUS GF-UCT180 EVIS EXERA II ULTRASOUND GASTRO VIDEOSCOPE have been designed to be used with the SSD-a10(K043196) diagnostic ultrasound systems (ALOKA CO.,LTD.), video system center, light source, documentation equipment, monitor, Endo-Therapy accessories such as aspiration biopsy needle and other ancillary equipment. The subject devices are designed for endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

I am sorry, but the provided text is a 510(k) summary and FDA letter for a medical device (endoscopic ultrasound system). It describes the device, its intended use, and compares it to predicate devices for substantial equivalence.

However, this document does NOT contain information about acceptance criteria, device performance results, specific study designs, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets those criteria, as it is not present in the provided text. This document is focused on regulatory clearance based on substantial equivalence to existing devices, not on the performance evaluation of an AI component.

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