(92 days)
The ORTHOPHOS XG 3D/ Ceph is intended to produce two dimensional images and three dimensional volume reconstructions, including partial volumes and selected projections of the dentomaxillofacial areas, for use in planning and diagnostic support. Image acquisition, modes include panoramic X-ray, cephalometric X-ray, specialized tomographic X-ray, and cone beam tomography X-ray. The system can also acquire carpal exposures. The system includes an X-ray source, flat panel X-ray detector, positioning devices, as well as interactive 3D reconstruction, processing, and archiving software.
The ORTHOPHOS XG 3D/ Ceph is a dental computed tomography system intended to produce X-rays for obtaining two dimensional images (panoramic and cephalometric) and three dimensional volume reconstructions of the teeth, jaw, and the head area, which includes dentomaxillofacial areas, for use in planning and diagnostic support. In 3D mode the OP XG 3D device generates a conical x-ray beam that rotates round the patient´s head within a certain angle.
The device comprises a combi sensor with 2D panoramic and cephalometric sensors and a flat panel sensor for 3D volume exposure. Five volume regions are defined by the geometry of the ORTHOPHOS XG 3D/ Ceph. Four class I laser beam light localizers serve for postioning the patient's head that may be fixed through bite block and adjustable forehead and temple supports.
From the obtained exposures in the 3D mode a three dimensional image is reconstructed and can be viewed as well as panoramic/cephalometric images. The constructed 3D volume and simulated projection exposures as well as panoramic/cephalometric data are conveyed to SIDEXIS and stored in the SIDEXIS data base.
An operator control panel allows height adjustment, selection of mode and program and indicates machine states.
A separate handhold push-button serves for exposure release.
An optional remote control is available.
The provided text describes a 510(k) summary for the Sirona Dental Systems ORTHOPHOS XG 3D/Ceph, which is an X-ray imaging device. The document does not contain information about acceptance criteria, detailed device performance metrics, or a study that proves the device meets specific acceptance criteria in terms of diagnostic effectiveness or accuracy.
Instead, this 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, which is a regulatory pathway for medical devices. The "study" mentioned here refers to nonclinical testing for technical equivalence, not a clinical study to establish diagnostic performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not available in the provided document. The 510(k) summary for this device focuses on demonstrating substantial equivalence to predicate devices (Sirona GALILEOS and Sirona ORTHOPHOS XGDS) rather than presenting specific quantitative acceptance criteria for diagnostic performance and corresponding study results.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided document. The nonclinical testing mentioned was performed using "test phantoms" (see Section 7), not human subjects or a defined dataset with provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not available in the provided document. As clinical testing was not performed and phantoms were used, there was no need for experts to establish ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not available in the provided document. No clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study in the document. This device is an X-ray imaging system, and there is no indication of AI assistance being evaluated in this context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device described is an X-ray imaging system, not an AI algorithm. Its performance is tied to image acquisition and reconstruction, not an automated diagnostic algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the nonclinical testing, the "ground truth" was implicitly the known physical properties and characteristics of the test phantoms used to evaluate exposure equality and conformance with FDA guidance (see Section 7). No expert consensus, pathology, or outcomes data were used as "ground truth" for diagnostic performance.
8. The Sample Size for the Training Set
This information is not available in the provided document. The document describes a medical device, not a machine learning algorithm that requires a training set. The "PC software" mentioned (Section 5.2.1) performs reconstruction and processing but is not described as involving a learnable model with a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not available and not applicable as there is no mention of a training set for a machine learning algorithm.
Summary of the "Study" Mentioned in the Document:
The "study" referenced in the 510(k) summary is "NONCLINICAL TESTING" (Section 7).
- Type of Study: System testing using test phantoms.
- Purpose: To evaluate the "equality of exposures" of the proposed ORTHOPHOS XG 3D/Ceph device against its predicate devices (ORTHOPHOS XGDS/Ceph and GALILEOS) in both 2D and 3D modes. For 3D mode, additional tests were performed in accordance with FDA Guidance for Solid State X-ray Imaging Devices.
- Methodology: Exposures were performed using "test phantoms." The specific types of phantoms or the quantitative metrics measured are not detailed beyond "equality of exposures."
- Conclusion: Based on this nonclinical testing, along with comparison of intended use, indications, construction materials, principles of operation, features, and technical data, the device was deemed "substantially equivalent" to the predicate devices and "safe and effective to perform its intended use."
- No Clinical Testing: Section 8 explicitly states, "Clinical tests have not been performed."
In essence, the document confirms that the device's technical specifications and image acquisition capabilities were tested against established standards and predicate devices using phantoms, rather than through a clinical study demonstrating diagnostic performance against specific acceptance criteria.
§ 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.