(78 days)
The Signa VH/i system is a head-only scanner designed to support higher resolution imaging and shorter scan times. The Signa VH/i 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.. The images produced by the Signa VH/i 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 3.0T Signa VH/i Magnetic Resonance System is a modification to the Signa CV// Magnetic Resonance System which utilizes a superconducting magnet to acquire 2D singleslice and multi-slice, and 3D volume images. The GE 3T Signa VH/i MR System is a high resolution, head imaging system operating at 3 Tesla. 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 shorter scan times.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Medical Systems 3.0T Signa VH/i Magnetic Resonance System:
Summary:
The provided 510(k) submission for the GE 3.0T Signa VH/i MR System is a "Summary of Safety and Effectiveness" report from 1999. It focuses on demonstrating substantial equivalence to a predicate device (Signa CV/i Magnetic Resonance System) rather than presenting a detailed clinical study with specific acceptance criteria related to diagnostic performance. The key "study" described is compliance with established performance and safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with NEMA Performance Standards | Evaluated to appropriate NEMA performance standards. (Specific standards or results not detailed in submission) |
| Compliance with IEC 601-1 Safety Standard | Evaluated to IEC 601-1 International medical equipment safety standard. (Specific results not detailed in submission) |
| Compliance with IEC 601-2-33 Safety Standard | Evaluated to IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. (Specific results not detailed in submission) |
| Substantial Equivalence to Predicate Device | Determined to be substantially equivalent to the Signa CV/i Magnetic Resonance System (1.5T whole-body scanner), differing primarily in field strength (3.0T) and being head-only. |
| No new indications for use | The 3.0T Signa VH/i system's indications for use are consistent with the predicate device. |
| No new potential hazards | It is the opinion of GE that the 3.0T Signa VH/i System does not result in any new potential hazards. |
Explanation: The document does not specify quantitative acceptance criteria or clinical performance metrics (e.g., sensitivity, specificity, accuracy) for image quality or diagnostic capability. Instead, it relies on demonstrating compliance with existing industry standards and substantial equivalence to a previously cleared device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a specific test set of patient data or images used for evaluating diagnostic performance. The "study" described is primarily focused on engineering compliance and comparison to a predicate device's specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no specific test set or clinical performance evaluation is described, there's no mention of experts used to establish ground truth.
4. Adjudication Method for the Test Set
As no test set for diagnostic performance is described, there is no adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done or reported in this submission. The submission is focused on device equivalence and safety standards, not on evaluating human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is an MRI scanner, a hardware diagnostic imaging device, not an AI algorithm. Therefore, no standalone performance study was conducted in the sense of an algorithm operating independently for diagnosis. The performance evaluation relates to its physical and imaging capabilities.
7. The Type of Ground Truth Used
The primary "ground truth" implicitly used for this submission is:
- Compliance with established engineering and safety standards (NEMA, IEC 601-1, IEC 601-2-33).
- The performance and safety profile of the predicate device (Signa CV/i Magnetic Resonance System).
There is no mention of pathology, expert consensus on patient diagnoses, or outcomes data being used as ground truth for a clinical performance study.
8. The Sample Size for the Training Set
This document describes a medical imaging device (MRI scanner), not an AI system that undergoes training. Therefore, there is no concept of a "training set" as would be applicable to machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device, this question is not applicable.
§ 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.