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Stellaris 2D: Extraoral source dental X-ray system intended to perform panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry.

Stellaris 2D Ceph: Extraoral source dental X-ray system intended to perform panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.

Stellaris 3D: Extraoral source dental X-ray system intended to perform 3D and panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry.

Stellaris 3D Ceph: Extraoral source dental X-ray system intended to perform 3D, panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.

Stellaris 3D is a dental X-ray system for Panoramic and Cone Beam Computed Tomography (CBCT) which allows to perform all the radiographic projections, both 2D and 3D, of most interest for the dentist, the surgeon and the maxilla-facial radiologist.

In addition to the functions of Panoramic and 3D radiography, Stellaris 3D Ceph also allows to perform One-Shot Cephalometric radiographs.

Stellaris 2D is a dental X-ray system for Panoramic which allows to perform all the radiographic projections of most interest for the dentist, the surgeon and the maxilla-facial radiologist.

In addition to the functions of Panoramic, Stellaris 2D Ceph also allows to perform One-Shot Cephalometric radiographs.

Except for the panoramic acquisition sensor, the remaining mechanical, electrical and software characteristics of Stellaris 2D are exactly identical to those of Stellaris 3D.

The control panel interface on the unit provides a complete control of the operation and for the setting of the desired technique factors.

Class I LASER aiming lights support positioning of patient's head, which is stabilized through the use of bite blocks, chin rest, and, if required, temple supports.

The user controls the exposure using a manual hand-switch, implementing the dead man functionality.

An Ethernet connection cable allows the FONA Stellaris devices to interface with a computer for image acquisition, processing and storage.

The provided document is a 510(k) Premarket Notification from FONA S.r.l. to the FDA for their Stellaris dental X-ray systems. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and adherence to relevant standards.

The document does NOT describe the acceptance criteria for an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria.

The Stellaris devices are dental X-ray systems (2D and 3D, with and without cephalometric capabilities). The document explicitly states:

• "The Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices can be used with the OrisWin DG Suite software for image acquisition and database (not part of this submission)..." (page 8)
• "...the 3D sensor has been replaced with a 2D sensor." (page 10)
• "The principle of operation of the Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices remains the same as the predicates. The difference is the type of sensors used which work on similar principles as the sensors found in the predicate devices." (page 7)

There is no mention of any AI or machine learning components within the device itself for diagnostic or image processing purposes that would require specific performance criteria or a study as outlined in the request. The "reconstruction algorithm" mentioned is standard for CT and panoramic imaging, not an AI/ML algorithm requiring separate clinical performance validation from the device's image acquisition capabilities.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document describes a traditional 510(k) submission for an imaging device, demonstrating substantial equivalence through technical characteristics, safety standards (IEC, EN), software standards (EN 62304), and biocompatibility (ISO 10993-1).

In summary, none of the requested information regarding AI/ML acceptance criteria or a comparative study proving device performance against such criteria can be found in this document.

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