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510(k) Data Aggregation
(14 days)
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
The GE Signa® Excite MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa® Excite MR system is indicated for use as a diagnostic imaging device to produce axial 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, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® Excite system 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® Excite 1.5T and 3.0T Magnetic Resonance Systems are a modification to the previously cleared Mr Systems K015000, and K030874 which utilizes a superconducting magnet to acquire 2D Single and make images. The Signa® Excite make a superconducting magnet operating at 1.51 and 0.0 r Magnolis (1600)and institution system supports 1, 4, 8, 16 independent receive channels and multiple independent coil elements per channel during a single acquisition channolo and manification is designed for expansion in 16 channel Sencs. The system can image in the sagittal, coronal, axial, oblique and double oblique increments. The system our mage in the sage are acquired and reconstructed using 2D and planes, asing ranous palos objaction. The system is intended for high-resolution anatomical applications, short scan times, and multinuclear spectroscopy.
Here's a breakdown of the requested information based on the provided text for K041476. It's important to note that this 510(k) summary is for a Magnetic Resonance (MR) system, which typically has different performance evaluation criteria than, for instance, an AI-powered diagnostic device. The 'acceptance criteria' here refer more to meeting established performance standards for the MR system itself and demonstrating substantial equivalence to predicates, rather than specific diagnostic accuracy metrics.
1. Table of Acceptance Criteria and Reported Device Performance
For an MR system, acceptance criteria are generally related to its technical specifications, compliance with safety standards, and performance characteristics like resolution, signal-to-noise ratio (SNR), and scan times. Since this is a submission for a modification to existing MR systems, the "acceptance criteria" revolve around demonstrating that the modified devices (Signa® Excite 1.5T and 3.0T MR Systems) maintain the safety and effectiveness of the predicate devices and comply with relevant standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Substantial Equivalence (1.5T System) | The Signa® Excite 1.5T MR System is described as "substantially equivalent to the currently marketed The Signa® 1.5T Infinity MR system (K013636)." The main difference cited is a change to the receive channels (10 receive channels, allowing for future expansion in 16 channel increments). GE states its opinion that "Usage of the Signa® Excite 1.5T Magnetic Resonance System does not result in any new potential hazards." |
| Substantial Equivalence (3.0T System) | The Signa® Excite 3.0T MR System is described as "substantially equivalent to the currently marketed The Signa "Excite U.S.T. MIT System (K030874)." The main differences cited are a change to the receive channels (16 independent receive channels, allowing for future expansion in 16 channel increments). GE states its opinion that "Usage of the Signa® Excite 3.0T Magnetic Resonance System does not result in any new potential hazards." |
| Safety and Performance Standards | The systems were "evaluated to the appropriate NEWs performance standards as well as the IEC 60601-1 International Medical Equipment Safety Standard and ISO 23647 Magnetic Resonance Equipment for Medical Diagnosis." (Note: The provided text contains a typo for ISO standard, "120 0000 - 12 Signal," which should likely be corrected during review, but the intent is clear). The text explicitly states the 3.0T system is "comparable to the currently marketed Signa® 3.0T Infinity with Excite Technology Magnetic Resonance System." |
| Technical Capabilities | The device description highlights capabilities such as:Superconducting magnet operating at 1.5T and 3.0T.Supports 1, 4, 8, 16 independent receive channels and multiple independent coil elements per channel during a single acquisition (designed for expansion in 16 channel increments).Can image in sagittal, coronal, axial, oblique, and double oblique planes using various pulse sequences.Intended for high-resolution anatomical applications, short scan times, and multinuclear spectroscopy. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not mention a discrete "test set" in the context of diagnostic accuracy, sample size, or data provenance (e.g., country of origin, retrospective/prospective). This is because the submission is for a general-purpose MR system, not an AI-powered diagnostic algorithm. The evaluation focuses on meeting engineering and safety standards and demonstrating equivalence to predicate devices, not on a case-based clinical performance study as one would expect for an AI algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As explained above, this submission is for an MR imaging device, not an AI algorithm requiring expert-established ground truth for a diagnostic test set.
4. Adjudication Method for the Test Set
Not applicable. No test set or human adjudication process is described in this 510(k) summary for the MR device itself.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This is a submission for an MR imaging system hardware modification, not a standalone algorithm.
7. Type of Ground Truth Used
Not applicable in the conventional sense of a diagnostic device. For an MR system, "ground truth" relates to its ability to accurately produce images that reflect the spatial distribution of protons (as stated in the Indications for Use), its adherence to technical specifications, and compliance with performance and safety standards. This is validated through engineering tests, phantom studies, and comparison to established predicate device performance and standards, rather than pathology or outcomes data from patients used to establish "ground truth" for a diagnostic algorithm.
8. Sample Size for the Training Set
Not applicable. This is an MR system, not an AI algorithm, and therefore there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm described, this point is irrelevant to the provided document.
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