(80 days)
The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The Signa Infinity Magnetic Resonance System is a modification to the Signa TwinSpeed Magnetic Resonance System (K012200) which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The Signa Infinity Magnetic Resonance System features a superconducting magnet operating at 1.5T. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques. The system is intended for high resolution anatomical applications and short scan times. Previously cleared software options, coils, and other accessories may · be used with the Signa Infinity Magnetic Resonance System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Signa Infinity MRI System:
Based on the provided 510(k) summary, the GE Signa Infinity Magnetic Resonance System is presented as a modification of an existing device, the Signa TwinSpeed MR system (K012200). The submission focuses on demonstrating substantial equivalence rather than a new device with novel performance claims requiring extensive clinical outcome acceptance criteria.
Therefore, the "acceptance criteria" for this device are primarily related to performance and safety standards adherence and substantial equivalence to the predicate device, rather than diagnostic accuracy or effectiveness against a specific disease state. The "study" described is a technical evaluation rather than a clinical trial.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Demonstrates equivalence to predicate device (Signa TwinSpeed MR system, K012200) with described modifications. | "The Signa Infinity Magnetic Resonance System is substantially equivalent to the Signa TwinSpeed Magnetic Resonance System." "Usage of the Signa Infinity Magnetic Resonance System does not result in any new potential hazards." |
| Technical Performance | Compliance with appropriate NEMA performance standards. | "The Signa Infinity Magnetic Resonance System was evaluated to the appropriate NEMA performance standards." |
| Electrical Safety | Compliance with IEC 601-1 International Medical Equipment Safety standard. | "The Signa Infinity Magnetic Resonance System was evaluated... as well as the IEC 601-1 International Medical Equipment Safety standard." |
| MR Equipment Safety | Compliance with IEC 601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis. | "The Signa Infinity Magnetic Resonance System was evaluated... and IEC 601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis." |
| New Hazards | The modifications (eight independent receive channels, updated Computer and RF Pulse Control subsystems, ASSET imaging for eight channels) do not introduce new hazards. | "Usage of the Signa Infinity Magnetic Resonance System does not result in any new potential hazards." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not describe a "test set" in the context of clinical images or patient data for evaluating diagnostic performance. The evaluation focused on device performance against technical and safety standards and comparison to a predicate device.
- Data Provenance: Not applicable, as there was no clinical test set described. The "data" would be engineering and performance measurements.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth typically refers to clinical diagnosis or pathology for a medical image analysis device. This submission is for an MRI system itself, not an AI or image analysis tool.
- Qualifications: Not applicable.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring expert adjudication was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is the MRI scanner itself, not an AI assistance tool for human readers.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This document describes an MRI system, which produces images for interpretation by a human physician, not a standalone algorithm for diagnosis.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the "study" described (evaluation against standards and comparison to predicate), the "ground truth" would be the established NEMA, IEC 601-1, and IEC 601-2-33 standards for MRI system performance and safety, and the performance characteristics of the predicate Signa TwinSpeed MR system. There isn't a clinical "ground truth" in the sense of patient outcomes or pathology.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This MRI system is not an AI model that requires a "training set" of patient data in the computational sense. The development of the system itself would involve extensive engineering and testing, but these are not referred to as "training sets" in this context.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable. As explained above, there is no "training set" for this type of medical device submission.
§ 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.