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The EG-3670URK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy

The EG-3670URK, Ultrasound Video Gastroscope, must be used with a Pentax Video processor (a software controlled device) and must be used with an Ultrasound Scanner (a software controlled device). The endoscope has a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water/ and suction. The ultrasound umbilical connector will be attached to the ultrasound scanner unit. The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, suction selection control, balloon insufflation/ evacuation, and an accessory inlet port. The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic image data, and a radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced. The video processor contains a lamp that light and is focused at the PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and the signals are passed to the ultrasound scanner for processing and 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 510(k) summary for the PENTAX EG-3670URK Ultrasound Video Gastroscope does not contain information about acceptance criteria or a study that proves the device meets such criteria.

The submission explicitly states: "The submission for substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to predicate devices primarily through mechanical drawings, material lists, labeling, standard components, optional accessories, and system performance testing (which likely refers to technical specifications rather than diagnostic performance in a clinical context) and acoustic power data.

No clinical study, performance metrics, or ground truth establishment is described in this 510(k) summary.

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