(15 days)
The GE Precision MPi is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
The GE Precision MPi is a multi-purpose system that can perform general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.
The GE Precision MPi tilt-C consists of an X-ray Generator, Right or Left side suspended Angulations Table with X-ray Tube, Collimator and Image Intensifier, Operators console, and Digital Imaging/Archive system.
The provided text does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy studies.
This document is a 510(k) premarket notification for a medical device called the "GE Precision MPi Universal tilt-C." It's a traditional medical device (an X-ray system), not an AI/ML powered device.
The information primarily focuses on:
- Device Description: An X-ray Generator, Angulations Table with X-ray Tube, Collimator and Image Intensifier, Operators console, and Digital Imaging/Archive system.
- Intended Use: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
- Technological Differences: States there are no technological differences between the GE Precision MPi and its predicate device (Philips MultiDiagnost 4, K961374).
- Conformance: Adherence to relevant sections of 21CFR (1020.30, 1020.31, 1020.32) and standards like UL60601-1, IEC60601-1.
- Conclusion: Substantial equivalence to the predicate device.
Therefore, I cannot provide the requested table or answer the questions related to AI/ML device performance, sample sizes for test/training sets, ground truth establishment, or expert adjudication, as this information is not present in the given text.
§ 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.