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The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for general populations. The device must only be operated and used by dentists and other legally qualified professionals.

The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is modified from the IMAGEWORKS PANOURA (K122806).

The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The device must only be operated and used by dentists and other legally qualified professionals.

Panoura X-ERA PF/NF/MF consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. The Console is new software and classified as moderate level concern. 3D Viewer will then perform the image analysis or image edition such as creating cross-section diagram.

3D sensor is not installed for Panoura X-ERA PF. Medium FOV sensor is installed for Panoura X-ERA NF. Large FOV sensor is installed for Panoura X-ERA MF.

The provided text is a 510(k) summary for the Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device. It focuses on demonstrating substantial equivalence to a predicate device (IMAGEWORKS PANOURA, K122806).

Crucially, this document does not contain information about acceptance criteria for an AI-powered device, nor does it describe a study specifically proving an AI device meets such criteria.

The "Panoura X-ERA PF/NF/MF" is an extraoral source x-ray system, a hardware device for capturing dental images. While it "consists of a scanner... and a Console, which is used for operating the scanner and managing the data. The Console is new software and classified as moderate level concern. 3D Viewer will then perform the image analysis or image edition such as creating cross-section diagram," this software appears to be purely for imaging acquisition, management, and basic viewing/editing, not for AI-driven diagnostic or analytical capabilities. The key changes mentioned are software and the addition of a 3D sensor.

The "studies" mentioned are "Bench Testing" which compared test pattern images and confirmed conformity with various IEC standards (electrical safety, radiation safety, laser safety). Software validation was done according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," which is a general guideline for medical device software, not specific to AI performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI device meets the acceptance criteria, as this document describes a traditional imaging hardware device with associated operational software, not an AI product.

If you have a document specific to an AI medical device, I would be happy to analyze it for the requested information.

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