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Zsquare ENT-Flex endoscope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic endoscope procedures.

Zsquare ENT-Flex endoscope is a flexible, high-resolution endoscope with a narrow insertion diameter composed of a Single-Use Shell, provided sterile, that fully encompasses a reusable Imaging Core. The Zsquare ENT-Flex endoscope is intended to visualize the internal cavities of the ear, airways, nose, and sinus cavities during diagnostic endoscope procedures. The endoscope is to be used with a Console provided by Zsquare in a hospital or clinic environment. This device is designed to reduce the need for high-level disinfection and/or sterilization between patients by providing a sterile disposable Single-Use Shell that is used in combination with a reusable Imaging Core.
The Zsquare ENT-Flex system consists of a/an:
• Endoscope comprised of a:
• Disposable Single-Use Shell that is comprised of the handle, the steering mechanism, and the steerable shaft (imaging fiber, illumination fiber and distal optics). It is the only part that contacts the patient and physician's soiled hands and is disposed of at the end of the procedure.
• Reusable Imaging Core, which is a hand-held multi-use unit containing the optical system that is composed of a lens array and a camera. At the end of a procedure, the Imaging Core is disengaged from the Shell and cleaned with ethanol wipes.

• · Console comprised of a/an:
  • o Illumination Unit
  • o Camera Control Unit (CCU)
  • o Monitor/Screen
  • Keyboard with touchpad
  • o Footswitch
  • o Cart
    The console enables the image-processing. A data cable connects to the endoscope and transfers the video data to the image-processing unit. The image is transferred and displayed on a graphical user interface (i.e.: monitor).
    Power is supplied to the camera contained in the Imaging Core by a cable from the CCU. A second cable is connected to the illumination source to control the illumination.

The provided text is a 510(k) summary for the Zsquare ENT-Flex endoscope. It focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and non-clinical performance data. Crucially, this document does not contain information about acceptance criteria for a specified performance study, nor does it describe a study proving the device meets such criteria.

The document primarily covers non-clinical bench testing for various aspects like image parameters, mechanical properties, illumination, mating cycles, IP rating, color performance, latency, sterilization, packaging, shelf-life, biocompatibility, software verification, electromagnetic compatibility, and electrical safety. These are standard validation tests for medical devices but are not framed as a "study that proves the device meets the acceptance criteria" in the context of clinical or performance outcomes that would typically involve a test set, ground truth, or expert readers.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study proving the device meets them because the provided text does not contain this specific information. The document focuses on demonstrating physical and technical equivalence, not a clinical performance study with the requested metrics.

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