(10 days)
The Signa Profile/i MR system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Profile/i with High Slew Rate Option MR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa Profile/i MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Due to the 'open' design of the system, the Profile/i with High Slew Rate Option MR system may also be utilized for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.
The 0.2T Signa Profile/i MR System is a modification to the 0.2T Signa Profile/i MR System (K992135), which utilizes a permanent magnet to acquire 2D sindle-slice and multi-slice, and 3D volume images. The 0.2T Signa Profile/i Magnetic Resonance System also features a permanent magnet operating at 0.2T. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences, such as inversion recovery, spin echo, gradient echo, gradient recalled, and steady state, and free precession acquisitions. The Signa Profile/I operator has the ability for shorter scan times due to expanded gradient capabilities. Imaging options such as cardiac gating, peripheral gating, glow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality.
The provided document is a 510(k) summary for the GE 0.2T Signa Profile/i Magnetic Resonance System. It describes a modification to an existing MR system, primarily increasing the gradient slew rate capability and adding a new high SNR head coil.
However, the document does not contain information typically found in a study demonstrating how a device meets specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc.) for AI/CAD devices. This 510(k) focuses on the substantial equivalence of an updated MR imaging system, not a diagnostic algorithm.
Therefore, most of the requested information regarding acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this type of submission.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document describes an updated MR scanner, not a diagnostic algorithm with performance metrics like sensitivity or specificity. The "performance" mentioned relates to increased gradient slew rate and improved SNR, which are hardware specifications, not diagnostic accuracy. The study summarized evaluated the system against NEMA performance standards and IEC safety standards, which are technical and safety compliance criteria, not outcome-based diagnostic performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set of patient data for diagnostic performance evaluation is mentioned. The studies referenced are hardware performance and safety evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No expert-established ground truth for diagnostic performance is mentioned as part of this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication process for diagnostic performance is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is an MR scanner, not an AI/CAD system. No MRMC study is referenced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is an imaging system, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth for diagnostic performance is relevant to this submission.
8. The sample size for the training set
- Not Applicable. This device is an MR scanner, not an AI/CAD system that requires a training set of data.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth establishment is relevant to this submission.
Summary of Studies and Basis for Substantial Equivalence (as provided in the document):
The document states:
"The Signa Profile/i Magnetic Resonance System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International Medical Equipment Safety standard and IEC 601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis."
This indicates that the "study" was focused on compliance with established technical performance (NEMA) and safety standards (IEC), rather than clinical diagnostic performance against specific acceptance criteria for disease detection. The conclusion is that "The Signa Profile/i Magnetic Resonance System is comparable to the currently marketed Signa Profile/i Magnetic Resonance System," and "Usage of the Signa Profile/i Magnetic Resonance System does not result in any new potential hazards." This forms the basis for the substantial equivalence determination for this updated MR scanner.
§ 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.