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The Biop Digital Colposcope is intended for magnified viewing of the vagina, cervix and external genitalia, in order to assist doctors in diagnosing abnormalities such as lesions or cancer and selecting areas for biopsy. The images from the Digital Colposcope are to be viewed on a color display. The Biop Digital Colposcope is intended for use in hospitals, clinics, and doctor's offices.

The Biop Digital Colposcope comprises 3 components:
. Biop Digital Colposcope Control unit;
. Biop Digital Colposcope unit;
Dedicated PC (touch screen) containing software and vertical stand.
The Biop Digital Colposcope is designed to be utilized at a working distance (WD) of 8" (200mm) -12" (300mm) from the cervix and acquires magnified images according to the doctor's requirements. The colposcope includes LED illumination and digital green filter capabilities as well.
The user can operate the Biop Digital Colposcope unit using the keypad on the Biop Digital Colposcope Control unit and/or via the touch screen of the PC. Via the operation screen on the monitor, the user can visualize the cervix, take snapshots, take video, and use the green filter and additional illumination functionalities. Each of these functions can be controlled and adjusted by designated menus.
The touch-screen graphical user interface (GUI) consists of three menu options: Menu 1, 2, or 3, which allow control over the Biop Digital Colposcope, including the illumination system, zoom functions and Pan options. Each Operation Screen can be used during the colposcopy exam and shows the video taken by the Biop Digital Colposcope camera in real time. Images acquired during colposcopy are shown on the right of the screen. The user can toggle through all images obtained via the Biop Digital Colposcope unit and, if indicated, can acquire the biopsies in a standard manner. In addition, the system also enables full screen presentation of the images.

This document describes the Biop Digital Colposcope and its equivalence to a predicate device. However, it does not contain specific acceptance criteria for a device's performance in diagnosing abnormalities or selecting areas for biopsy using AI or advanced algorithms, nor does it provide a study proving such criteria are met. The document focuses on the physical and optical specifications of the colposcope itself, and its compliance with general medical device standards.

Therefore, for the specific questions requested, much of the information cannot be found in the provided text.

Here is what can be extracted or inferred:

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

The document lists various specifications and states that the device "met its predefined optical specifications" or "met predefined specifications" for those criteria. It does not provide specific acceptance values or thresholds for all listed specifications, nor does it present "device performance" in terms of diagnostic accuracy, sensitivity, or specificity, as the device itself is a viewing tool, not an AI diagnostic system.

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