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EzMobile is dental imaging software that is intended to provide various tools for maxillofacial radiographic imaging. These tools are available to view a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzMobile is intended for use as software to acquire, view and save 2D image files, load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

EzMobile is dental imaging software that is intended to provide various tools for maxillofacial radiographic imaging. These tools are available to view a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzMobile is intended for use as software to acquire, view and save 2D image files, load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

The provided text is an FDA 510(k) clearance letter for EzMobile, a dental imaging software. It does not contain information about acceptance criteria for a device's performance or a study proving the device meets acceptance criteria related to diagnostic accuracy or AI performance metrics.

The clearance letter primarily addresses regulatory compliance and substantial equivalence to a predicate device. The "Indications for Use" section describes the software's intended function (viewing/saving DICOM dental images, etc.) but does not specify performance metrics or a study demonstrating their achievement.

Therefore,Based on the provided document alone, I cannot provide the requested information regarding the acceptance criteria and the study that proves the device meets them. The document is an FDA clearance letter focusing on regulatory compliance and substantial equivalence, not a performance study report.

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