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The EG-3870UTK, 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

PENTAX EG-3870UTK Ultrasound Video Gastroscope + HI VISION PREIRUS are the endoscopic ultrasound system consists of an ultrasound endoscope with a curved linear array type ultrasound transducer, video processor, and Hitachi ultrasound scanner. This modified new system configuration is to work together with the already cleared latest Hitachi HI VISION PREIRUS Diagnostic Ultrasound Scanner (K093466).

The provided text is a 510(k) summary for a medical device called "PENTAX EG-3870UTK Ultrasound Video Gastroscope (Curved Linear Array Type) + HI VISION PREIRUS". It describes a modification to an already cleared system. This document is a regulatory submission for premarket notification, not a clinical study report detailing acceptance criteria and performance data for a device.

Therefore, I cannot provide the requested information about acceptance criteria and device performance based on the provided text for the following reasons:

• This is a Special 510(k) submission for a modification, not a de novo clearance or a typical 510(k) requiring detailed performance data against acceptance criteria. The submission explicitly states: "There are no software or hardware changes between the PENTAX EG-3870UTK Ultrasound Video Gastroscope subject and predicate device in connecting with the new Hitachi HI VISION PREIRUS Diagnostic Ultrasound Scanner. In addition, there are no change in technology, including features, materials, and principles of operation." The modification is simply a change in the ultrasound scanner used with the endoscope.
• The justification for clearance is "substantial equivalence" to a predicate device, not demonstration of meeting specific performance acceptance criteria through a clinical study. The document states: "The system configuration modification does not impact the intended use, safety and/or effectiveness. The modified system configuration has been verified and validated according to the company's design control activities as certified in this Special 510(K) Submission's declaration of conformity with design control to ensure the compatibility between the PENTAX EG-3870UTK Ultrasound Video Gastroscope and the HITACHI HI VISION PREIRUS Ultrasound Scanner." This implies compatibility testing, not a formal clinical trial with acceptance criteria for diagnostic performance.
• No clinical study to demonstrate "device performance" in terms of sensitivity, specificity, accuracy, etc., is described. The document focuses on the equivalence of the modified system.

In summary, the provided document does not contain the information required to populate the requested table and answer the questions about acceptance criteria, study details, sample sizes, ground truth, experts, or comparative effectiveness studies. This type of information is typically found in full clinical study reports, which are usually not part of a Special 510(k) for a system configuration change like this.

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