(23 days)
PreXion 3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three dimensional digital X-ray images of the dental (oral), maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand wrist to obtain carpus images for growth and maturity assessment.
PreXion 3D Excelsior consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Excelsior Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer. 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 inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure.
The provided text is a 510(k) Summary for the PreXion 3D Excelsior device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study proving device performance against those criteria in the context of an AI-driven diagnostic aid.
Specifically, the document discusses:
- Device Description: The PreXion 3D Excelsior is a dental cone-beam computed tomography (CT) device.
- Modifications from Predicate: The subject device adds a "CT-panoramic" mode (reconstructing panoramic images from CT raw data) and an "Airway measurement function" (calculates volume and cross-section area of airways).
- Non-Clinical Performance Data: Conformance to various harmonized standards (e.g., IEC 60601-1, ISO 14971) and specific testing for 3D imaging performance (MTF for three image orientations).
- Software Quality Activities: Compliance with software moderate level concern based on risk management and usability evaluation, including bench tests and user evaluations.
- Conclusion: The device is substantially equivalent to the predicate device.
However, the document does NOT provide the requested information regarding acceptance criteria related to AI/Machine Learning performance (e.g., sensitivity, specificity, AUC) or a clinical study proving AI-driven diagnostic aid performance. The "Airway measurement function" is described as an additional supplemental function, but no performance metrics for this automated measurement function are presented, nor is it explicitly stated to be an AI-driven diagnostic aid in the sense of pattern recognition or disease detection.
Therefore, I cannot extract the information required to formulate the table and answer the detailed questions about acceptance criteria for an AI device and the study proving it meets those criteria. The provided submission is for a medical imaging device (CT scanner) and its software, not an AI diagnostic software that requires assessment of diagnostic accuracy.
§ 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.