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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, Duodenum, Small There monded out is not room to introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

The FG-36UX, Fiber Ultrasound Gastroscope, can be used with any Lightsource (with the appropriate itemble insertion tube, a control body, and Umbilicus . The umbilicus is bifurcated where one connector is connected to the Lightsource and contains connections for air/water and suction. The other umbilicus Comments is connected at the ultrasound scanner. The control body includes controls for up/ down/ left/ right angulation an accessory elevator control, air/water delivery, suction selection/ control, forward water jet port, allyon insulflation, an accessory inlet port, and the endoscopic image viewing occular. The device contains light oundon insurrition, and to illuminate the body cavity another to optically visualize the anatomy, and an ultrasound carrying out 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 allay aunsation on for display. The instrument is immersable (with the use of supplied cleaning accessories) Onazound Deminer for Gisplay : The measur (as described in the Endoscope operator Manual cleaning instructions).

This looks like a 510(k) summary for a medical device, which typically describes the device, its intended use, and how it is substantially equivalent to a predicate device. It doesn't contain detailed information about a study proving the device meets specific acceptance criteria with performance metrics, sample sizes, and expert qualifications.

The document explicitly states: "The substantial equivalence was not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information because the document does not contain details about a study with acceptance criteria and device performance. The device's clearance was based on substantial equivalence to predicate devices, not on a new clinical performance study demonstrating direct fulfillment of specific performance metrics.

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