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The aScope Duodeno is designed to be used with the aBox Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. video monitor) for endoscopy and endoscopic surgery within the duodenum.

The aBox Duodeno is designed to be used with the aScope Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. medical grade video monitor) for endoscopy and endoscopic surgery within the duodenum.

The Ambu Duodeno System consists of a sterile single-use endoscope, the aScope Duodeno, and a processing unit, the aBox Duodeno.

The sterile single use duodenoscope aScope Duodeno consists of a flexible insertion tube with bendable tip, a control body and an umbilicus cord. The insertion tube has a bendable tip which is equipped with a camera to collect image data and a LED light source to illuminate the body cavity. The device contains a working channel through which additional instruments as biopsy devices may be introduced. The aScope Duodeno provides functions for lens washing, insufflation and suction.

The aBox Duodeno is an endoscopic video imaging system that receives video signals from the connected endoscope, controls the light at the endoscope tip and outputs this signal including a graphical user interface (GUI) to a connected external video monitor. It also provides signals to capture images by a connected external image capturing system. The aBox Duodeno also contains a peristaltic pump to provide water for the endoscope lens washing function. The peristaltic pump is controlled by the operator via the endoscope.

The provided text describes the Ambu Duodeno System, a sterile single-use duodenoscope, and its associated processing unit, the aBox Duodeno. The document outlines its intended use, device description, comparison to predicate devices, and performance testing, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The document details non-clinical and animal testing to demonstrate substantial equivalence to predicate devices (Olympus TJF-Q180V and EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180). This type of testing focuses on functional performance, safety, and physical characteristics of the duodenoscope itself, not on the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets acceptance criteria, as the provided text relates to the regulatory clearance of a traditional medical device (a duodenoscope) and not an AI/ML-powered device.

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