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The X-View 3D PAN/X-View 2D PAN 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 X-View 3D PAN/X-View 2D PAN dental panoramic and cephalometric device is intended for general populations as long as they are older than 10 years.

The device must only be operated and used by dentists and other legally qualified professionals.

The X-View PAN is manufactured by Trident s.r.l. and it can be sold under two different commercial names:

• X-View 3D PAN
• X-View 2D PAN

Both devices, depending on the configuration chosen, can be equipped with a cephalometric arm equipped with a 24x30 cm flat panel sensor for the execution of cephalometric radiographs of various formats and latero-lateral and antero-posterior projections. The cephalometric device can also be added in the field.

The device can be set in the configurations: Floor version with column and wall bracket and Floor version with column and standard base.

The subject dental X-ray system X-View is supported by software (firmware). The software is of Moderate Level of concern and is FDA-cleared.

The provided text is a 510(k) Summary for a medical device called X-VIEW 3D PAN/X-VIEW 2D PAN. It describes the device, its intended use, comparison to predicate devices, and performance data. However, the document does not contain information about specific acceptance criteria, a detailed study proving the device meets those criteria, or the specific performance metrics (e.g., sensitivity, specificity) of the device.

The document primarily focuses on demonstrating substantial equivalence by:

• Comparing technological characteristics with predicate devices.
• Listing adherence to various international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6/IEC 62366-1, IEC 60601-2-63, IEC 60825-1).
• Mentioning software verification and validation, risk analysis (ISO 14971), and biocompatibility.
• Stating that "Clinical tests were performed both in Italy at the University of Genoa and the clinical judgment made by ABR, President of Dental Imaging Consultants, LLC, have demonstrated the clinical validity of the X-View systems both in the execution of PAN-type exams and 3D volumetric exams. Images were presented and approved by the ABR Consultant." This is a general statement about clinical validation, not a detailed performance study with specific metrics, sample sizes, or ground truth establishment.

Therefore, I cannot provide the requested information from the given document as it does not contain quantifiable performance data or specified acceptance criteria for algorithm performance. The document focuses on showing the device is substantially equivalent to existing devices based on technical specifications and adherence to safety and performance standards rather than demonstrating specific diagnostic performance metrics of an AI or algorithmic component.

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