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hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is digital panoramic, cephalometric and tomographic extra-oral system, intended to:

(1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;

(II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH);

(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dentomaxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMD), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

The Proposed device is a panoramic, cephalometric and tomographic radiological system developed and manufactured by CEFLA S.C. The proposed device is a change of the predicate device: hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS (K214084). Like the predicate device the proposed device can be sold under three different proprietary product name and brands for commercial needs, without changing any of the basic safety, essential performances and functional features:
1 hyperion X9 pro myray CEFLA S.C.
2 NewTom GIANO HR NewTom CEFLA S.C.
3 X-RADIUS TRIO PLUS Castellini CEFLA S.C.
Wherever the Proposed device is mentioned the device with its three different trade/ proprietary names: hyperion X9 pro, New Tom GiANO HR and X-RADiUS TRiO PLUS.
Like the predicate device hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS (K214084) the proposed device is equipped with X-ray tube generator and X-ray sensors (Solid State X-ray Imaging Detectors) for dental panoramic (PAN), cephalometric radiography (CEPH) and computed tomography (CBCT). The proposed device permits to acquire radiological images (panoramic images, cephalometric images and 3D volumes) at varying radiographic angles by rotating around the patient following different trajectories depending on the selected examination. The exposed area can be adapted to a specific region of interest to keep the radiation dose as low as possible for the patient. This is achieved by collimating the x-ray beam and the adjustment of starting and ending points of the x-ray source and sensor movement. Furthermore, the radiation dose can be adapted by various parameters such as examination types and exposure technique factors. Class I lasers pointers are utilized to define reference lines for the patient position. The patient stabilized through adjustable patient supports, can sit or stand. Control panel allows user actions as: height adjustment, selection of examination, and exposure parameters and delivers information about the unit status. The obtained digital image data are processed to provide a reconstructed image. The images are transferred to a computer, in real time or later depending on the needs and choice of the operator. The software used to manage the images, essential for CBCT acquisitions, is NNT/iRYS, a radiological imaging software developed by CEFLA S.C.

This document describes a 510(k) premarket notification for a dental X-ray system. The key aspect of this submission is that the Proposed Device is a modification of an existing, legally marketed Predicate Device. The modifications primarily involve the availability of alternative 2D X-ray detectors. Therefore, the study presented here focuses on demonstrating substantial equivalence to the predicate device, rather than proving novel performance against a clinical ground truth.

1. Acceptance Criteria and Reported Device Performance

Since this is a submission demonstrating substantial equivalence to an existing device, the "acceptance criteria" are predominantly the adherence to various medical device standards and the maintenance of comparable performance to the predicate device. The "reported device performance" is largely framed in terms of "no significant difference" or "comparable" to the predicate, as the goal is to show the new version is as safe and effective as the old.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a traditional "test set" sample size in terms of clinical cases or patient images. This submission relies on a comparison against the predicate device's established performance and adherence to engineering and safety standards. The testing described is primarily non-clinical performance testing to verify conformity with various IEC standards (electrical safety, EMC, radiation protection, software lifecycle, usability, dental x-ray specific requirements).

• Sample Size: Not specified in terms of clinical images or patient data, as the study is not based on a new clinical performance claim but on equivalence to a predicate. It indicates "Verification activities for confirmation of the image quality of the proposed device has been performed." This implies technical tests on samples, phantoms, or test patterns, rather than a large human-read image dataset.
• Data Provenance: Not explicitly stated for specific test data, but the manufacturer is CEFLA S.C. based in Imola, Italy. The testing would have been conducted as part of their device development and validation processes, likely at their facilities or certified labs. The study is a non-clinical validation comparing the proposed device's technical specifications and test results to those of the predicate device and relevant standards. It is retrospective in the sense that it relies on existing data/standards for the predicate and engineering tests for the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts

This type of submission (510(k) for substantial equivalence based on non-clinical performance and direct comparison to a predicate) typically does not involve establishing ground truth through multiple expert clinical readers for a test set. The "ground truth" here is the established safety and performance of the predicate device and the adherence to relevant international standards.

If image quality was assessed, it would likely be through technical metrics (e.g., MTF, contrast, noise) rather than subjective clinical readings by multiple radiologists. The document references "image quality review," which could involve internal engineering and quality experts. No specific number or qualifications of experts for image review are provided in this summary.

4. Adjudication Method for the Test Set

Not applicable for this type of submission. There is no multi-reader, multi-case study or a need for clinical adjudication to establish ground truth for a diagnostic accuracy claim. The comparison is based on engineering specifications and adherence to standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Given the differences from the predicate device, no human clinical studies have been considered necessary to support substantial equivalence." This means the submission relies on non-clinical performance data and a direct comparison of features and technical specifications to the legally marketed predicate device.

Therefore, there is no effect size of how much human readers improve with AI vs. without AI assistance, as AI assistance is not the subject of this submission, nor is a human-in-the-loop performance study.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is an X-ray imaging system, not an AI software algorithm. Therefore, "standalone" algorithm performance testing is not applicable in this context. The core function is image acquisition, not algorithmic analysis of images.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly the already established and FDA-cleared performance and safety of the predicate device (K214084), combined with compliance with relevant international and national standards (e.g., IEC 60601 series, IEC 62304). The study aims to demonstrate that the small changes introduced do not alter this established 'ground truth' of safety and fundamental performance. It is not based on expert consensus for disease detection, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device (X-ray system), not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no AI algorithm training set involved.

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