(44 days)
The OEC Fluorostar is a mobile digital C-arm designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, stone localization, critical-care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.
The OEC Fluorostar is a mobile digital C-arm.
The provided text is a 510(k) premarket notification letter from the FDA to GE OEC Medical Systems, Inc. for their OEC Fluorostar device. It primarily focuses on the FDA's "substantial equivalence" determination and regulatory classification.
The document does not contain information about acceptance criteria for device performance, a study proving the device meets these criteria, sample sizes for test sets or training sets, data provenance, details about ground truth establishment, or any information related to multi-reader multi-case (MRMC) studies or standalone algorithm performance.
Therefore, I cannot provide the requested information based on the given text.
The closest relevant information is the "Indications For Use Statement" which describes the intended purpose of the device: "The OEC Fluorostar is a mobile digital C-arm designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, stone localization, critical-care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion."
To answer your request, I would need a different type of document, such as a clinical study report, a performance validation report, or a detailed technical specification submitted as part of the 510(k) application itself, which would elaborate on how the device's technical performance was tested and proven.
§ 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.