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The CareView 1500Cw 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 1500Cw is a kind of wireless portable digital X-ray flat panel detectors which have 434mm×355mm 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 describes a 510(k) premarket notification for the CareView 1500Cw X-ray Flat Panel Detectors. It does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML device.

The document focuses on demonstrating substantial equivalence to a predicate device (ViVIX-S Wireless, K122865) based on:

• Technological Characteristics: Comparing specifications like image matrix size, pixel pitch, effective imaging area, grayscale, spatial resolution, etc.
• Nonclinical studies: Evaluation of parameters like Detective Quantum Efficiency (DQE), Modulation Transfer Function (MTF), noise power spectrum (NPS), spatial resolution, etc.
• Clinical considerations: A "concurrence study of 30 clinical images" comparing the proposed device to the predicate.

Therefore, I cannot provide the requested information for an AI/ML device as it is not present in the provided document. The device described is an X-ray flat panel detector, not an AI/ML-driven diagnostic tool.

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