(14 days)
The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions 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 body.
Depending on the region of interest being imaged, contrast agents may be used.
The images produced by the SIGNA Pioneer reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
The SIGNA Pioneer features a 3.0T superconducting magnet with a 70cm bore size.
The RF receiver is equipped with 97 RF channels.
The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of nuclei exhibiting magnetic resonance.
The system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms.
The SIGNA Pioneer uses multi-drive RF transmit for imaging of the head and body regions.
The SIGNA Pioneer is designed to conform to NEMA DICOM standards.
This 510(k) summary (K153003) for the GE Healthcare SIGNA Pioneer Magnetic Resonance Diagnostic Device does not describe acceptance criteria or a study that proves the device meets specific performance criteria.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (SIGNA Pioneer, K143345). The primary goal of a 510(k) submission is to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily to independently prove its performance against a set of acceptance criteria in a clinical study for a specific diagnostic task.
Here's a breakdown of why the requested information cannot be fully provided from this document:
- No specific "acceptance criteria" are defined for diagnostic performance. The document focuses on regulatory compliance and safety.
- No "study that proves the device meets the acceptance criteria" for a diagnostic task is presented. The "Summary of Clinical Tests" explicitly states: "The modification that prompted this submission did not require clinical testing."
However, I can extract information related to the device description and the non-clinical testing performed to demonstrate substantial equivalence, which is the focus of this submission.
Based on the provided document, here's what can be gathered, addressing your points where possible, and noting when the information is unavailable:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria for diagnostic imaging performance (e.g., sensitivity, specificity for detecting a specific pathology) or reported device performance against such criteria. The "performance" described is largely in terms of meeting safety standards and technical specifications equivalent to the predicate device.
| Acceptance Criteria (not explicitly defined for diagnostic performance in this document) | Reported Device Performance (as per non-clinical tests for equivalence) |
|---|---|
| Compliance with general medical device standards | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, ISO 10993-1 |
| Compliance with MRI-specific standards | Complies with applicable NEMA MS standards for MRI |
| Compliance with DICOM standards | Complies with NEMA PS3 standard for DICOM |
| Safety criteria for Local SAR (Specific Absorption Rate) | Verified to meet the same safety criteria as predicate device for local SAR for various anatomies via human modeling simulations. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for test set: Not applicable and not provided. No clinical test set for diagnostic performance was used in this submission. The verification of SAR used human modeling simulations.
- Data provenance: Not applicable as no clinical test set data was used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No clinical test set requiring expert ground truth was performed for this submission. The document focuses on technical and safety equivalence.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication was performed for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. The document explicitly states: "The modification that prompted this submission did not require clinical testing."
6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done
- This device is a magnetic resonance scanner, not an AI algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable in this context. The device produces images and/or spectra that are "interpreted by a trained physician" (human-in-the-loop by definition).
7. The Type of Ground Truth Used
- Not applicable. No clinical study with a ground truth for diagnostic performance was conducted for this submission. Safety verification used "local SAR human modeling simulations."
8. The Sample Size for the Training Set
- Not applicable. This document describes a medical imaging device (MRI scanner), not an AI algorithm that would typically require a "training set" of data in the context of machine learning. The "development" refers to the engineering and design of the hardware and software for the scanner itself.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of an AI algorithm as typically understood. The development process involved "Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), Simulated use testing (Validation)." This refers to engineering and quality assurance practices, not establishing ground truth for AI model training data.
Summary of this particular 510(k) submission (K153003):
This document is a regulatory submission for a new iteration of an MRI device, the SIGNA Pioneer. The core of this submission is to demonstrate substantial equivalence to an existing predicate device (SIGNA Pioneer, K143345). This generally means showing that the new device has the same intended use, fundamental technological characteristics, and safety/effectiveness profile as the predicate. It does not involve independent clinical trials to prove new diagnostic performance claims or to establish new acceptance criteria for such claims beyond what was established for the predicate device. The "modification" mentioned is likely a minor change that did not warrant a full clinical study for re-evaluation of diagnostic efficacy.
§ 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.