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The PantOs equipment, model PantOs 16, and PantOs DG are indicated for individuals requiring extra-oral dental radiographic examinations and diagnosis of diseases of the teeth, jaw, and oral structures. It exposes and acquires radiographic images at the dentomaxillofacial region. Depending on the model, the anatomical structures are visualized either on a radiographic film or on a computer display, through a dedicated image-intensified fluoroscopic x-ray system.

PantOs 16 is an X-ray equipment for dental panoramic radiography and for Cephalometry when completed with lateral arm (Ceph version. PantOs 16 has an X-ray generator with anodic voltage from 60 to 86 kV (constant potential), anodic current from 4 to 10 mA (direct current). Positioning the patient is done using a bite block or a chin rest, a few simple steps are required: once the height of the carriage is adjusted manually to bring the Frankfurt plane horizontally, correct rotation of the head is checked with the mirror. Front teeth alignment (to align to the in-focus-layer) is done by moving manually the carriage (backward or forward) till correct position is determined with the aid of the lateral light beam (the unit is adjusted without the need to move the patient). PantOs DG performs like PantOs 16 and is equipped with a digital panoramic receptor instead of film cassette, thus producing panoramic images on the display of a computer system.

The provided text describes a 510(k) summary for the PantOs X-ray equipment (models PantOs 16 and PantOs DG) and focuses on establishing substantial equivalence to legally marketed predicate devices. It does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a regulatory submission for a medical device (an X-ray machine), and as such, it primarily details the device's technical specifications, intended use, and its comparison to predicate devices for regulatory approval. It is not a clinical study report or a performance evaluation against specific performance metrics.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study proving the device meets those criteria based on the provided text. The document's purpose is to demonstrate substantial equivalence, not to provide detailed performance study results against predefined acceptance criteria.

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