(267 days)
PreXion 3D is intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial regions at the direction of healthcare professionals as diagnostic support.
The PREXION 3D consists of scanner and two software including Console software, and Viewer software used for the Image Analysis System and Data processing. A qualified computer named Console computer is distributed with the PREXION 3D.
The PREXION 3D uses the Image Analysis System and the processed data acquired by the scanner to analyze 2D and 3D images, perform image edition, such as creating cross-section views, and output results to a printer or other output device.
During scanning, X-rays are generated from the X-ray tube head mounted in the arm of the scanner and the X-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware and the Console software installed on the qualified computer. The detected X-ray absorption data is processed by the Console software and viewer software on a computer to reconstruct images. Scanning is performed using X-ray penetration signals of a patient taken from multiple directions for the diagnosis of hard tissue including bones and teeth of the jaw and mouth cavity. The PREXION 3D performs two types of scanning including CT scan generating two (2) and three (3) dimensional images and Panoramic scan generating two (2) dimensional images.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device Name: PREXION 3D
K Number: K120948
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Explicit or Implied) | Reported Device Performance |
|---|---|---|
| Premarket Testing | (Implied: demonstrate substantial equivalence to predicate devices and conform to recognized standards) | (Conclusion: PREXION 3D is substantially equivalent to predicate devices FINECUBE (K063622) and CS 9300 (K103659) and does not raise new questions of safety or effectiveness. Meets requirements of recognized consensus/voluntary standards.) |
| Laser Safety | Compliance with IEC 60825-1 | Identical laser system to PANOURA 18S (K111231), which has a test report showing compliance with IEC 60825-1. |
| Modulation-Transfer Function (Spatial Resolution) | All scan modes must meet acceptance criteria (specific numerical criteria not provided). | The spatial resolution of all scan modes met the acceptance criteria (measured in accordance with IEC 61223-3-5). |
| Artifact Analysis | No significant difference in pattern and strength of metal artifacts compared to predicate. | No difference in pattern and strength of the metal artifact between the PREXION 3D and the FineCube (K063622) for all scan modes. |
| Software Verification/Validation | Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Software has been validated accordingly. |
| EMC | Compliance with IEC 60601-1-2 | Confirmed (details of specific tests not provided). |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-1 | Confirmed (details of specific tests not provided). |
| X-ray Radiation Safety | Compliance with IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 | Confirmed (details of specific tests not provided). |
| Risk Analysis | Deemed satisfactory in accordance with ISO14971:2007. | Risk management was deemed satisfactory. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided summary does not specify a sample size for a test set in the context of clinical or image-based studies with human subjects. The testing described focuses on technical performance metrics (MTF, artifact analysis) and safety standards, likely using phantoms or laboratory setups rather than patient data for "test sets" in the diagnostic performance sense.
Data Provenance: Not applicable in the context of the described technical bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for the technical tests (like MTF and artifact analysis) is established by measurement against defined physical standards or comparison to a predicate device's known performance, not by expert interpretation.
4. Adjudication Method for the Test Set
Not applicable, as the tests were technical and did not involve human interpretation or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on technical substantial equivalence, not comparative diagnostic effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
No, a standalone algorithm performance study was not explicitly described. The device, an X-ray system, produces images for human healthcare professionals to interpret; it is not presented as an AI-driven diagnostic algorithm. The software validation mentioned pertains to the software's functional correctness for image processing and system control.
7. The Type of Ground Truth Used
- For Laser Safety: Compliance with IEC 60825-1 (international standard).
- For Modulation-Transfer Function (Spatial Resolution): Measurements in accordance with IEC 61223-3-5 (international standard).
- For Artifact Analysis: Comparison to the predicate device (FineCube K063622). The "ground truth" here is the established and accepted performance of the predicate device.
- For Software Verification/Validation: Compliance with FDA guidance for software in medical devices.
- For EMC, Electrical Safety, X-ray Radiation Safety: Compliance with relevant IEC 60601 series standards.
- For Risk Analysis: Compliance with ISO 14971:2007.
8. The Sample Size for the Training Set
Not applicable. This device is an imaging system, not an AI/ML algorithm that requires a training set of data. The software validation is for the image acquisition and processing functions, which are deterministic, not for a learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 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.