(76 days)
The Signa CVMR system is a whole body scanner designed for shorter scan times. The Signa CVMR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa CVMR 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.
The Signa CVMR System is a modification to the Signa Horizon MR Systems which utilize a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. In addition to the wide variety of pulse sequences provided to the Signa Horizon operator, such as inversion recovery, spin echo, gradient echo, gradient recalled, and steady state, and free precession acquisitions, the Signa CVMR operator has the ability for shorter scan times due to expanded gradient capabilities. Imaging options such as cardiac gating, peripheral gating, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality.
The provided text describes a 510(k) premarket notification for the GE Signa CVMR Magnetic Resonance System. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner typically seen for autonomous AI/ML devices. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device and compliance with general safety and performance standards.
Here's an analysis based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a direct performance table. The "performance" assessment is framed in terms of compliance with established medical device standards and comparison to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with NEMA performance standards | Evaluated to appropriate NEMA performance standards |
| Compliance with IEC 601-1 International medical equipment safety standard | Evaluated to IEC 601-1 International medical equipment safety standard |
| Compliance with IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis | Evaluated to IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis |
| Substantial equivalence to predicate device (Signa Horizon System) in terms of safety and effectiveness for diagnostic imaging | Deemed substantially equivalent with no new hazards or indications for use. Main difference is the Body/Gradient coil to enable shorter scan times. |
| Production of transverse, sagittal, coronal, and oblique images of internal structures of the head or body | Indicated for use as a diagnostic imaging device to produce these images. |
| Images reflecting spatial distribution of protons based on proton density, T1, T2, and flow | Images produced by the system reflect these properties. |
| Images providing information useful in determining a diagnosis when interpreted by a trained physician | Indicated for this purpose. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission doesn't describe a clinical study of "test set" data for evaluating an algorithm's performance. The evaluation is focused on engineering and safety standards, and comparative equivalence to an existing device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. See point 2.
4. Adjudication Method for the Test Set
Not applicable. See point 2.
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
No. This document describes a traditional medical imaging device (MR system) and not an AI/ML diagnostic algorithm. Therefore, an MRMC study related to AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of AI/ML evaluation. The "ground truth" for this device's safety and effectiveness relies on:
- Engineering and electrical safety standards (NEMA, IEC).
- Demonstrated performance characteristics inherent to MR technology (e.g., ability to acquire T1/T2 weighted images, proton density).
- Clinical acceptance of the predicate device (Signa Horizon System) for its diagnostic capabilities when interpreted by trained physicians.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
Summary of the Study (as described in the document):
The "study" described in this 510(k) submission is primarily a technical and regulatory evaluation to demonstrate substantial equivalence to a previously cleared predicate device, the Signa Horizon System.
- Objective: To show that the Signa CVMR System is as safe and effective as the predicate device and does not raise new questions of safety and effectiveness.
- Methodology:
- Comparison with Predicate: The Signa CVMR System was compared to the Signa Horizon Systems, with the primary difference identified as a modified Body/Gradient coil allowing for expanded gradient capabilities and shorter scan times. The submission asserts that no new indications for use or potential hazards are introduced.
- Compliance with Standards: The device was evaluated against:
- Appropriate NEMA performance standards.
- IEC 601-1 International medical equipment safety standard.
- IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
- Conclusion: GE concluded that the Signa CVMR System is substantially equivalent to the Signa Horizon MR Systems. The FDA, based on this submission, concurred with the substantial equivalence finding.
§ 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.