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The aScope™ Duodeno 2 is designed to be used with the aBox™2, endoscopic accessories (e.g., biopsy forceps) and other ancillary equipment (e.g., medical grade video monitor) for endoscopic surgery within the duodenum.

The aBox ™2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ Duodeno 2 Endoscopy System is a combination of the duodenoscope, Ambu® aScope™ Duodeno 2 and the compatible displaying unit, Ambu® aBox™ 2.

The Ambu® aScope™ Duodeno 2, is a sterile and single-use medical device for endoscopic surgery within the duodenum.

The Ambu® aScope™ Duodeno 2 is a flexible endoscope) with side viewing optics, deflectable tip and an elevator to control the position of inserted accessories. The angulation of the endoscope tip is wheels, whereby the angulation can be locked via levers. The elevator (Albarran lever) is also controlled via a lever. Insufflation, suction and rinsing functions are activated via user controls. The product contains remote switches / programmable buttons of the connected Displaying Unit (Ambu® aBox™ 2). The Ambu® aScope™ Duodeno 2 must be connected to the Ambu® aBox™ 2 to be able to work.

The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8" LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.

The Ambu® aBox™ 2 has the following physical and performance characteristics:

• · Can process and display live imaging data from Ambu® aScope™ Duodeno 2 to a monitor
• · Can record, store and transport image data from Ambu® aScope™ Duodeno 2
• Is a portable device with an integrated monitor, and the possibility to connect to an external monitor

The provided text describes the regulatory clearance of a medical device (Ambu® aScope™ Duodeno 2 and Ambu® aBox™ 2), but it does not contain information about an AI-powered device or a study validating its performance against specific acceptance criteria for AI.

Therefore, I cannot extract the detailed information requested in your prompt (acceptance criteria table, sample size for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC study details, standalone performance, type of ground truth, etc.) because these elements are not present in the provided FDA 510(k) summary for the Ambu® aScope™ Duodeno 2 Endoscopy System.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and safety testing (e.g., geometrical characteristics, functional performance, optical performance, biocompatibility, electrical safety), not on the performance of a software algorithm against a specific clinical task with AI-defined acceptance criteria.

The information regarding acceptance criteria and performance in the document is general, stating: "In all instances, the Ambu® aScope™ Duodeno 2 Endoscopy System performed as expected and met the set test specifications." It lists types of tests performed (e.g., optical performance, image quality, electrical safety) but does not provide quantitative acceptance criteria or detailed study results for each.

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