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The PaX-Uni3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

The PaX-Uni3D diagnostic equipment consists of Digital Computed Tomography, Panoramic, and Cephalometric dental X-ray system. This device is a system based on Digital X-ray Imaging System (Computed Tomography Sensor to Capture X-ray Digital Computed Tomogram Scanned Image)

The provided document is a 510(k) summary for a dental X-ray imaging system (PaX-Uni3D). It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria related to AI or algorithm performance.

The safety and effectiveness data mentioned in section 8 refers to compliance with electrical, mechanical, environmental, and EMC standards (IEC 60601 series). This is standard for medical devices but does not involve AI performance evaluation.

Therefore, I cannot provide the requested table and study details as the information is not present in the provided text. The document focuses on showing substantial equivalence to a predicate device based on general safety and performance standards for an imaging system, not on the performance of a diagnostic algorithm or AI.

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