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LANMIX MLT add. version of Canon's X-ray Digital Cameras provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

The Canon X-ray digital camera model CXDI-11 LANMIX MLT add. version is used to directly capture and convert conventional projection X-ray images to digital images. A sub sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.

The Canon X-ray Digital Camera CXDI-11 LANMIX MLT add. version is substantially equivalent to the Canon Xrray Digital Camera CXDI-11. It differs from the CXDI-11 in that the LAN MIX MLT software was added to make possible the Multi-objective Frequency Processing.

The provided text describes a 510(k) summary for a new model of a Canon X-ray digital camera, the CXDI-11 LANMIX MLT add. version. It states that this device is substantially equivalent to a predicate device (Canon CXDI-11, K981556) and includes an addition of LANMIX MLT software for Multi-objective Frequency Processing.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The provided text is a regulatory submission summary, focusing on device description, intended use, and substantial equivalence to a predicate device, rather than detailed performance study results.

Therefore, I cannot fulfill the request to provide the specific information listed in your prompt based on the provided text.

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