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The detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.

The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor.

The detector should be connected to a computer and X-ray generator for transfer of diagnostic images. The functions of the EverestView 4343X are supported by software and the software is of Moderate level of concern. The main function of software is image acquisition and transfer and it doesn't have functions of image post-processing. The detectors can be used for dynamic imaging (fluoroscopy) that is same as Predicate Device.

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for an X-ray Flat Panel Detector (EverestView 4343X) and focuses on demonstrating substantial equivalence to a predicate device (CareView 1800RF) based on technological characteristics and safety testing.

It does include a comparison table of technical specifications between the proposed and predicate devices, which could be interpreted as comparative performance metrics, but these are not explicitly presented as acceptance criteria for a study proving clinical effectiveness.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding specific studies (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) as this information is not present in the provided text.

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