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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Transesophageal
Transrectal
Transvaginal
Transurethral
Other
1)Gastrointestinal tract, biliary, pancreatic duct and the surrounding Organs
2)Intraluminal ultrasound for upper airways and tracheobronchial tree
3)Urinary tract
4)Female reproductive tract

The combination of OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER, Ultrasonic Gastrovideoscope OLYMPUS GF TYPE UM160, and Ultrasonic probe OLYMPUS UM-DP12/20-35R makes a endoscopic ultrasound imaging system used to acquire and to display high-resolution and high-penetration, real-time ultrasound B-mode images.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details.

The text describes:

• A 510(k) premarket notification for the Olympus EU-M60 EUS Exera Endoscopic Ultrasound Center and its associated components (ultrasonic gastrovideoscope and probes).
• The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
• The intended uses for the device, including various clinical applications in B-mode operation (transesophageal, transrectal, transvaginal, transurethral, and "other" applications such as gastrointestinal tract, biliary, pancreatic duct, upper airways, tracheobronchial tree, urinary tract, and female reproductive tract).
• Details about the manufacturer, initial importer, contact person, device names, and classification.
• A list of predicate devices used for comparison.
• A brief device description and technological characteristics, stating that it operates identically to predicate devices in how it acquires and displays ultrasound images.

The document is a clearance letter from the FDA, and as such, it focuses on demonstrating substantial equivalence to pre-existing devices rather than presenting the detailed performance study results that would typically include acceptance criteria and a description of the study to prove those criteria were met.

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