(269 days)
DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 is indicated for use in generating radiographic images of human anatomy to replace the radiographic film/screen systems in all general purpose diagnostic procedures. It is also used for generating fluoroscopic images, when integrated into the X-ray diagnostic systems, to replace the spot-film devices and the X-ray image intensifiers.
Not intended for mammography applications.
The proposed CXDI-RF Wireless B1 is a solid state X-ray imager, which is capable of both fluoroscopic and spot radiographic imaging and has a common Thallium-doped Cesium Iodide (CsI:TI) scintillator. The CXDI-RF Wireless B1 will be integrated as a component into the Canon fluoroscopy x-ray system for fluoroscopic and radiographic imaging. The CXDI-RF Wireless B1 intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values. The digital values are sent to the PC via a wired or wireless connection, converted to images with the CXDI Control Software (CXDI Controller RF version 3.11), and then displayed on the PC/monitors. The PC/monitors used with the CXDI-RF Wireless B1 are not a part of this submission.
The provided document from the FDA 510(k) premarket notification for the Canon Inc. DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 does not contain information about acceptance criteria and a study proving that the device meets specific acceptance criteria related to AI/algorithm performance.
The document states that the device is a digital radiography and fluoroscopy system, which is hardware (a solid-state X-ray imager) with associated control software. It is not an AI/CADe (Computer-Aided Detection/Diagnosis) device with performance metrics like sensitivity, specificity, or AUC, which are typically evaluated against AI acceptance criteria.
The "Summary of Non-Clinical/Test Data" section primarily references adherence to technical standards, internal specifications, and FDA guidance documents for medical devices (e.g., biological evaluation, risk management, software life cycle, cybersecurity, electrical safety, radiation protection, usability, etc.). It emphasizes that "No clinical testing was required as non-clinical testing should be sufficient to demonstrate that the DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 works as intended."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets AI/algorithm-specific acceptance criteria, as the document does not describe such a study or performance metrics for AI.
If you have a document that specifically details the AI/CADe component of a different device, I would be happy to analyze it for the information you've requested.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.