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The Dental Cone Beam Computed Tomography System is intended to be used by medical institutions for X-ray image diagnosis on oral and maxillofacial areas through X-ray Cone Beam Computed Tomography (CBCT).

The system consists of X-ray tube assemblies, collimators, flat panel detector, control devices (the touch screen, the control panel, the console panel and the exposure switch), auxiliary positioning devices(the lifting seat and the chin rest) and U-shape gantry (the X-ray tube assembly support, the base and the Detector Support), and workstation. The system is an open design that allows patients to sit upright during a procedure. An electric powered seat is built into the scanner for proper patient positioning. The system has 2 configurations: the Configuration 1 has two X-ray tube assemblies(X-ray tube assembly A and X-ray tube assembly B) and two collimators(A and B), the Configuration 2 only has X-ray tube assembly A and collimator A. The proposed device is a CBCT dental system utilizes X-ray to obtain cross-sectional images of patient's oral and maxillofacial areas. The image software can reconstruct data and clearly display the 3D anatomical structure of the oral and maxillofacial areas, and achieve the multi-slice at any level, accurate measurement, contour plots and so on in the workstation software, greatly facilitating the clinical application of stomatology. The Lifting Seat moves up and down via buttons on the system Control Panel allowing positioning and adjustment of patients at different heights; the Touch Screen facilitates the adjustment of projection parameters and the control of actions of the device; the Gating and the shielding door are the safety interlock of the X-ray beam exposure to prevent the dose leakage caused by abnormal operation; the Exposure Switch controls the exposure output of the whole machine in real time during the scanning process. There are four FOV sizes; 20cm x 18cm high resolution is for diagnostic imaging of maxillary region, mandibular region, TMJ region and other craniofacial region, and it is only available for configuration 1; 17cm x 10.5cm high resolution , 8cm x8cm Super Resolution and 4cm x4cm Super Resolution are for diagnostic imaging of maxillary region and mandibular region. Under High Resolution mode, patients will receive lower radiation dose compared to Super Resolution. Dose radiation for each mode is different for pediatric and adult patients.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria for AI performance. The document is a 510(k) clearance letter for a Dental Cone Beam Computed Tomography System, which is a medical imaging device, not an AI-powered diagnostic tool.

The "Clinical Performance Data" section mentions that "Sample clinical images obtained from the subject device were provided to demonstrate its imaging performance. An ABR-certified radiologist with over 5 years of experience post-certification independently reviewed the sample scans and evaluated essential image quality. The overall image quality was acceptable for all cases and image types in various scanning modes for both adult and pediatric applications."

However, this review is about the imaging performance of the CBCT system itself, not about the performance of an AI algorithm within the system. There are no mentions of:

• Specific AI acceptance criteria (e.g., sensitivity, specificity, AUC)
• A test set for AI
• Ground truth establishment methods for AI
• MRMC studies or standalone AI performance
• Training set details for AI

Therefore, I cannot fulfill your request for information related to AI acceptance criteria and study data based on the provided text. The document focuses on the substantial equivalence of the CBCT system as an imaging device to a predicate device, covering aspects like electrical safety, EMC, biocompatibility, and general image quality assessment by a human radiologist.

To provide the information you requested, the input document would need to be a 510(k) for an AI/ML-powered device, or indicate that the "Dental Cone Beam Computed Tomography System" includes an AI component whose performance was evaluated for clearance.

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