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The FG-36UX. Fiber Ultrasound Gastroscope, is intended to provide optical visualization of , ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organs; tissues; and subsystems; Esophagus, Stomach, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy (Mode of Operation: B, M, Color Doppler, Amplitude Doppler)

The FG-36UX, Fiber Ultrasound Gastroscope, can be used with any Lightsource (with the appropriate lightguide receptacle) and must be used with Ultrasound Scanner (software controlled device). The endoscope has a flexible insertion tube, a control body, and Umbilicus is bifurcated where one connector is connected to the Lightsource and connections for air/water and suction. The other umbilicus bifurcation is connected at the ultrasound scanner. The controls for up/ down/ left/ right angulation, an accessory elevator control, air/water delivery, suction selection/ control, forward water jet port, balloon insufflation, an accessory inlet port, and the endoscopic image viewing ocular. The device contains light carrying bundles, one to illuminate the body cavity another to optically visualize the anatomy, and an ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). A convex linear array transducer delivers ultrasonic pulses, reflections of the pulses are received and signals are passed to the Ultrasound Scanner for display. The instrument is immersable (with the use of supplied cleaning accessories) except for the Ultrasound Scanner Connector (as described in the Endoscope operator Manual cleaning instructions).

The provided text is a 510(k) summary for the FG-36UX Fiber Ultrasound Gastroscope and its associated FDA substantial equivalence letter. It describes the device, its intended use, and its comparison to predicate devices. However, this document does not contain any information about acceptance criteria, clinical studies, device performance metrics, sample sizes, ground truth establishment, or expert reviews.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other details about a study proving the device meets acceptance criteria, as this information is not present in the provided input.

The document explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical performance data." This indicates that the 510(k) clearance was granted based on substantial equivalence to existing devices, without requiring a clinical study demonstrating performance against specific criteria.

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