(84 days)
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.