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Ambu® aScope™ 5 Broncho HD is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.

Ambu® aScope™ 5 Broncho HD is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing endotherapy instruments via its working channel.

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

The Ambu® aScope™ 5 Broncho HD system is a combination of the displaying unit, Ambu® aView™ 2 Advance, and a compatible Ambu endoscope, the Ambu® aScope™ 5 Broncho HD 5.0/2.2 or the Ambu® aScope™ 5 Broncho HD 5.6/2.8. The Ambu® aScope™ 5 Broncho HD bronchoscopes are the same devices as cleared in K220606. The only change is that the bronchoscopes are now also compatible to Ambu® aView™ 2 Advance.

The Ambu® aScope™ 5 Broncho HD endoscopes are single-use endoscopes designed to be used with Ambu displaying units, endotherapy instruments and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The insertion portion is inserted into the patient airway through the mouth, nose, or a tracheostomy. It is lubricated with a water-soluble medical grade lubricant to ensure the lowest possible friction when inserted into the patient. There is a working channel system within the endoscope for use with endotherapy instruments. An introducer (luer lock adaptor), which is supplied together with the endoscope, can be attached to the working channel port during use. Suctioning of blood, saliva, and mucus from the airway is possible through the suction system.

Ambu® aScope™ 5 Bronco HD features an integrated camera module, with built-in dual LED illumination. The image module provides a cropped 800x800 Pixels signal from the 1280x800 (1 megapixel) sensor.

The Ambu® aView™ 2 Advance, also referred to as displaying unit, is a non-sterile digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a 12.8" LCD screen. The device is powered through a Lithium-ion (Li-ion) battery or a separate power adapter.

Ambu® aView™ 2 Advance displaying unit has the following physical and performance characteristics:
Displays the image from Ambu® aScope™ 5 Broncho HD endoscope on the screen.
Can record snapshots or video of image from Ambu® aScope™ 5 Broncho HD endoscope.
Can connect to an external monitor.
Reusable device.

The provided text is a 510(k) summary for the Ambu® aScope™ 5 Broncho HD system. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence. However, this document does not detail a study proving the device meets an acceptance criterion for an AI/ML-driven medical device, nor does it provide a table of acceptance criteria and reported device performance in the context of an AI/ML study.

The document discusses performance tests for the medical device itself (bronchoscope and display unit), such as optical properties, mechanical performance, biocompatibility, and electrical safety. The "acceptance criteria" here refer to the device meeting these engineering and regulatory standards, not specifically to the performance of an AI/ML algorithm.

Therefore, I cannot answer your request based on the provided input text, as the information you are asking for (acceptance criteria and study details for an AI/ML device) is not present. The document focuses on the hardware aspects of a bronchoscope system.

To address your query, I would need a document that describes the development and testing of an AI/ML-based medical device.

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