(26 days)
The SIGNA Voyager is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time imaging. The SIGNA Voyager is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images and/or spectra, dynamic images, and parametric maps of the internal structures and organs of the entire body. Body structures for evaluation include, but are not limited to: head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the SIGNA Voyager reflect the spatial distribution and/or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The SIGNA Voyager system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial and oblique planes, using various pulse sequences and reconstruction algorithms. The system is offered as a new system installation, in either a fixed or a mobile configuration. The system features a 1.5T superconducting magnet with a 70cm bore size.
This document, K192426, is a 510(k) premarket notification for a magnetic resonance diagnostic device (MRI scanner), the SIGNA Voyager / SIGNA Voyager Quantum, submitted by GE Healthcare (Tianjin) Company Limited.
Based on the provided text, there is no specific information regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI/algorithm performance study. The document is a 510(k) summary focusing on demonstrating substantial equivalence to a predicate device (SIGNA Voyager K161567) and does not detail the evaluation of an AI algorithm's performance with respect to specific diagnostic criteria.
Instead, the summary emphasizes:
- Compliance with voluntary standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, and applicable NEMA MS standards for MRI.
- Quality assurance measures: Risk Analysis, Requirements Reviews, Design Reviews, Unit-level testing, Integration testing, Performance testing, Safety testing, and Simulated use testing.
- Lack of clinical studies required for substantial equivalence: "The subject of this premarket submission, SIGNA Voyager, did not require clinical studies to support substantial equivalence."
- Human subject scanning for design validation: "Scanning of human subjects on the SIGNA Voyager system has been conducted at GE Healthcare facilities as part of design validation activities in order to ensure that the modified device meets user requirements." This is for validating the device's performance (e.g., image quality, signal-to-noise ratio, scan times), not for evaluating an AI's diagnostic accuracy or impact on human reader performance.
Therefore, I cannot populate the requested tables and information about AI algorithm performance, as the provided document does not describe such a study or related acceptance criteria. The 510(k) is for the MRI hardware itself and its modifications, not an AI diagnostic adjunct.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.