(470 days)
- The Trinias is an Image-intensified fluoroscopic X-ray system, which is used for diagnostic imaging and interventional procedures as described in 21 CFR 892.1650.
- The Trinias is intended to be used for cardiac angiography, abdominal angiography, abdominal angiography, peripheral angiography, rolational angiography, multi-purpose angiography and whole body radiographic filluoroscopic procedures.
- The Trinias is intended to be used for interventional procedures such as invasive cardiology and interventional neuroradiology.
Image-intensified fluoroscopic X-ray system
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as requested.
The document is a 510(k) premarket notification letter from the FDA to SHIMADZU Corporation regarding their "Trinias" image-intensified fluoroscopic x-ray system. It confirms that the device is substantially equivalent to legally marketed predicate devices.
While it mentions the device name, regulation number, regulatory class, and general indications for use, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test or training sets.
- Data provenance, number/qualifications of experts, or adjudication methods for ground truth.
- Information about MRMC comparative effectiveness studies or standalone algorithm performance.
- Specifics on how ground truth was established for either test or training sets.
The document is primarily a regulatory approval letter, not a technical study report.
§ 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.