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The Orthophos Plus and Orthophos Plus/CD are intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The X-ray source is located outside the mouth. The system provides for panoramic imaging of the entire maxillofacial region as well as transverse slice imaging of the maxillary and mandibular regions.

The Orthophos Plus contains 23 factory installed programs that allow for comprehensive imaging of the entire maxillofacial region. The Orthophos Plus software programs allow for panoramic radiographs of the teeth, maxillary sinuses, and temporal mandibular joints, as well as transverse panoramic tomographs of the lateral, canine and anterior maxillary and mandibular regions. The device is equipped with various bite block and head positioning accessories. The device is also available with an optional cephalometric attachment (Orthophos Plus/CD).

The provided text is a 510(k) summary for a medical device (Orthophos Plus and Orthophos Plus/CD dental X-ray system) seeking substantial equivalence to a predicate device. This type of submission generally does not contain detailed acceptance criteria or a specific study proving the device meets those criteria, as it focuses on demonstrating equivalence rather than a full de novo validation.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text.

The document only states the intended use, device description, and an assertion of substantial equivalence based on minor modifications to a previously cleared device. It explicitly states: "These technical changes do not alter the intended use of the device, nor do they raise new questions of safety and effectiveness." This implies that the original studies/data for the predicate device (Orthophos and Orthophos C, cleared under K895467) would have established their safety and effectiveness, and the modifications to the Orthophos Plus are not considered significant enough to require new, extensive performance studies for 510(k) clearance.

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