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The CareView 1800Cw 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.

CareView 1800Cw is a kind of wireless, portable digital X-ray flat panel detectors which have 244 mm x 307 mm imaging area. The device communicates by not only the wireless communication but also wired communication feature (Giga-bit Ethernet communication mode by connecting the power box) optionally.

The device intercepts X-ray photons and then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. After the electrical signals are generated, it is converted to a digital value and an image will be displayed on the monitor.

The detector should be integrated with an operating PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic.

The detector can't provide feedback to the generator to terminate the x-ray exposure.

The provided text is a 510(k) premarket notification for the CareView 1800Cw X-ray Flat Panel Detectors. It focuses on demonstrating substantial equivalence to a predicate device (CareView 1500Cw) and details aspects of the device's design, intended use, and technical characteristics.

However, the document does not contain information on "acceptance criteria" for algorithms (like AI), studies proving device performance against such criteria, data provenance, expert ground truth establishment, or comparative effectiveness studies of AI-assisted reading. The document is a regulatory submission for a medical imaging detector itself, not an AI software or algorithm.

Therefore, I cannot provide the requested information based on the given text. The provided text is about the hardware (X-ray detector), not about AI for image analysis.

To clarify, the information you're asking for (acceptance criteria for algorithms, expert adjudication, MRMC studies, standalone performance, etc.) is typically associated with the evaluation of AI algorithms or CAD (Computer-Aided Detection/Diagnosis) systems that process medical images. This document describes the performance characteristics of an X-ray detector, which is a piece of hardware that acquires the image.

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