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The ENTity WiFi Video Nasopharyngoscope System is intended to be used for oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords.

The ENTity WiFi Video Nasopharyngoscope System is a complete video nasopharyngoscopy system that includes a rechargeable, battery-powered, flexible videoscope with an integral LED light source and WiFi connectivity; a video processor box that receives WiFi signals from the videoscope and provides HDMI output to a video monitor; image management and user interface software; a battery charger accessory for the videoscope; and an active touchscreen monitor accessory that can be used to view images and/or to communicate with the software user interface. Light generated by the LED light source located in the videoscope handle is transmitted through glass fiber optic bundles to the distal tip of the scope, where it illuminates the anatomy to be examined. A CMOS image sensor (camera chip) located at the distal tip of the videoscope captures still or video images in the form of electrical signals, which are wirelessly transmitted to the ENTity WiFi Video Processor. The video processor incorporates user interface and image management software. Still and/or video images may be viewed on the ENTity WiFi Active Touchscreen Monitor; the touchscreen features on the monitor can also be used to interact with the ENTity WiFi Video Processor.

The provided text describes the ENTity WiFi Video Nasopharyngoscope System and its substantial equivalence to a predicate device. However, it does not contain a specific study proving the device meets particular clinical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for identifying specific conditions). The document focuses on showing substantial equivalence based on technical characteristics, non-clinical performance data, and compliance with various engineering and safety standards.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I detail a study that proves such criteria were met, as that information is not present in the provided text.

I can, however, extract information about the non-clinical performance and testing performed to demonstrate safety and technical equivalence.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with clinical acceptance criteria (e.g., diagnostic sensitivity/specificity) and corresponding device performance data for ENTity WiFi Video Nasopharyngoscope System. Instead, it lists technical features and compliance with standards.

Here's a table based on the technical comparison and performance verification mentioned, rather than clinical acceptance criteria for diagnostic efficacy.

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