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This ultrasound center is intended to be used with Olympus ultrasound endoscopes, Olympus ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time ultrasound images and indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree, and urinary tract.

The subject system, EU-Y0008 ENDOSCOPIC ULTRASOUND CENTER, combined with Ultrasound videoscopes or Ultrasound probes to make an endoscopic ultrasound imaging system that can acquire and display high-resolution and high-penetration. real-time ultrasound images of the target organs. The subject system has modes of B, PWD, Color Doppler, Combined and Others (3-D Imaging and Harmonic Imaging) and Elastography function which visualizes the amount of strain in tissue (hardness of tissue) during compression and retraction. The subject system provides measurements and calculations of distance, area, circumference, volume, time and blood velocity and provides storage and retrieval of images for review and printing. The subject system enables the user to print images and record images to external recording devices. Additionally, the subject system enables the user to record movies to internal memory. The subject system can identify and recognize compatible Olympus transducers and display endoscopic images in addition to ultrasound images.

I am sorry, but I am unable to extract information about acceptance criteria and study details from the provided document. The document appears to be a 510(k) Premarket Notification from the FDA for a medical device (ENDOSCOPIC ULTRASOUND CENTER EU-Y0008).

This type of document typically focuses on establishing substantial equivalence to previously cleared devices rather than presenting detailed study results or specific acceptance criteria. It mentions indications for use and technological characteristics in comparison to predicate devices, but does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results (effect size).
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

The document states that "The subject system has been designed to meet the applicable safety standards," but does not elaborate on specific performance criteria or the studies conducted to verify them. It primarily focuses on the device's intended use, modes of operation (B, PWD, Color Doppler, Combined, 3-D Imaging, Harmonic Imaging, Elastography), and its substantial equivalence to predicate devices (EU-Y0006 and HI VISION Preirus).

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