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As a part of the Canon radiography system, the CXDI Control Software when used with a compatible Canon detector is intended to provide digital image capture, processing, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.

The Intelligent NR (Intelligent Noise Reduction) function is a part of the CXDI Control software for the Canon detectors (with version 3.10 of the CXDI Control Software) that makes use of the Intelligent NR function to reduce noise for X-ray images taken using the Canon detectors. The Intelligent NR function was developed using machine-learning and trained by using an existing clinical image database to learn the characteristics of noises and create noise reduced images. The Intelligent NR function does not perform machine learning after release to users. The CXDI control software, which Intelligent NR is a part of, provides system control, controls GUI on the monitor, and processes images. The Intelligent NR function works on a PC and displays to a monitor. The Intelligent NR function is used in conjunction with the cleared Canon detectors compatible with CXDI Control Software V3.10. The firmware within compatible Canon detectors to be used with this device is unchanged, and no firmware update is necessary for compatibility with the Intelligent NR.

The provided text describes Canon Inc.'s Intelligent NR (Intelligent Noise Reduction) function, which is a new feature within their CXDI Control Software. This function utilizes machine learning to reduce noise in X-ray images. The submission aims to demonstrate substantial equivalence to a predicate device (Enhanced Feature Software Pack for CXDI Series, K190368).

However, the provided document does not contain the specific acceptance criteria or details of a study proving the device meets those criteria, as typically found in a clinical performance study report. The document focuses on regulatory information, device description, and comparison to a predicate device for substantial equivalence.

Therefore, I cannot directly populate the requested table and answer the questions related to acceptance criteria and specific study details (like sample size, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set details) from the provided text.

Based on the available information, I can infer some general aspects:

• Device Purpose: To reduce noise in X-ray images using machine learning.
• Context: The Intelligent NR is a feature of the CXDI Control Software, not a standalone device.
• Regulatory Goal: To demonstrate substantial equivalence to an existing predicate device. This typically involves showing that the new device does not raise new questions of safety and effectiveness.

Here's a breakdown of what can be extracted and what is missing:

The provided text focuses on the regulatory submission process and the general description of the device's function. It does not include the detailed performance study results, acceptance criteria, or the methodology of such a study.

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