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The Fujinon ultrasonic processor SU-8000 is intended to be used in combination with Fujinon/Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: General Application
Specific: Tran-esoph. (non-Card.), Other (Specify)
Mode of Operation: B, M, PWD, Color Doppler, Combined1
Other includes gastro-intestinal tract and surrounding organs

Fujinon Ultrasonic Processor SU-8000 is a new ultrasonic processor, which can be used with the previously-cleared ultrasonic gastrointestinal endoscopes, EG-530UR and EG-590UT via K063847.

Fujinon Ultrasonic Processor SU-8000 consists of a scan engine and a function box and SU-8000 is controlled by keyboard (model: CP-8000) SU-8000 connects to ultrasonic endoscopes, which emits ultrasound in a body cavity by driving ultrasonic transducers of the endoscope. SU-8000 also processes the reflection of ultrasonic signals the transducer and converts it to an ultrasound image.

SU-8000 is used in combination with ultrasonic endoscopes, video processor, light source, cart, recorder, foot switch and other peripheral devices (e.g. external monitor and printer), which is the same as the legally marketed device, SU-7000.

I am unable to provide a structured response about acceptance criteria and study details based on the provided text. The document is a 510(k) summary for the Fujinon Ultrasonic Processor SU-8000, which states:

• "No clinical test was conducted."
• The device was evaluated in accordance with various IEC safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, etc.).
• Substantial equivalence to a legally marketed device (SU-7000) was established based on having the same Indications for Use and very similar Functional and Technical requirements.

This type of submission focuses on demonstrating safety and effectiveness through adherence to recognized standards and substantial equivalence to existing devices, rather than through a new clinical study with specific acceptance criteria and performance metrics typically associated with AI/algorithm validation. Therefore, the requested information (such as sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, ground truth details for test/training sets) is not present in this document.

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