(55 days)
hyperion X9 pro, NewTom Giano HR, X-RADiUS TRiO PLUS is a digital panoramic, cephalometric and tomographic extra-oral X-ray 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, when equipped with tele-radiographic arm (CEPH):
(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMI), 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.
Not Found
This FDA clearance letter does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.
Specifically, the following information is not provided in the given text:
- A table of acceptance criteria and the reported device performance: This document does not include any performance metrics, thresholds, or a direct comparison to acceptance criteria.
- Sample size used for the test set and the data provenance: There is no mention of the number of cases or patients used for testing, nor the origin (country, retrospective/prospective) of any data.
- Number of experts used to establish the ground truth for the test set and their qualifications: The document does not discuss expert involvement in ground truth establishment.
- Adjudication method: There is no information regarding how disagreements among experts (if any were used) were resolved.
- Multi-reader multi-case (MRMC) comparative effectiveness study: The document does not mention whether such a study was performed or any effect size related to AI assistance.
- Standalone (algorithm-only) performance: While the device is an X-ray system, it's not an AI-driven diagnostic algorithm whose standalone performance would typically be reported.
- Type of ground truth used: The document does not specify if expert consensus, pathology, or outcomes data was used for validation.
- Sample size for the training set: As there's no mention of an AI algorithm or a training process, this information is absent.
- How the ground truth for the training set was established: Similarly, this information is not applicable or provided.
The document indicates that the devices (hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS) are digital panoramic, cephalometric, and tomographic extra-oral X-ray systems, and it describes their intended uses, such as producing images of the maxillofacial region, jaws, skull, and for cephalometric and tomographic examinations. The substantial equivalence determination is based on the comparison to predicate devices, but the specific performance data for this equivalence is not detailed in this FDA letter.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.