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510(k) Data Aggregation
(30 days)
The 0.7T Signa OpenSpeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa 0.7T Signa® OpenSpeed with Excite Magnetic Resonance 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.
Due to the 'open' design of the Signa 0.7T Signa® OpenSpeed with Excite may also be used for imaging during interventional procedures when performed with MR compatible devices such as. in-room display and MR safe biopsy needles
The 0.7T Signa® OpenSpeed with Excite Maqnetic Resonance System is a modification to the 0.7T Signa® OpenSpeed Magnetic Resonance System (K012875) which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System features a superconducting magnet operating at 0.7T. 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, short scan times, and multinuclear spectroscopy.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the GE 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System:
Based on the provided 510(k) summary, this document is a notification for a modification to an existing device (Signa® 0.7T OpenSpeed MR System, K012875), not a brand-new device. Therefore, the "acceptance criteria" discussed are primarily related to meeting performance standards and establishing substantial equivalence to the predicate device, rather than explicit diagnostic performance metrics (e.g., sensitivity, specificity) for a disease state. The study is focused on demonstrating that the modified device performs comparably and safely.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for a modification to a predicate device) | Reported Device Performance (from "Summary of Studies") |
|---|---|
| Compliance with NEMA Performance Standards | "The 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System was evaluated to the appropriate NEMA performance standards." (Details of specific NEMA standards and quantitative results are not provided in this summary but are implied to have been met.) |
| Compliance with IEC Safety Standards (IEC 601-1 and IEC 601-2-33) | "The 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System was evaluated to... the IEC 601-1 International Medical Equipment Safety standard and IEC 601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis." (Details of specific outcomes are not provided, but compliance is implicit.) |
| Substantial Equivalence to Predicate Device (Signa® 0.7T OpenSpeed, K012875) | "The 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System is comparable to the currently marketed Signa® 0.7T Open Speed Magnetic Resonance System." |
| "It is the opinion of GE that the 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System is substantially equivalent to the Signa® 0.7T OpenSpeed Magnetic Resonance System. Usage of the 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System does not result in any new potential hazards." (The core of the submission is to demonstrate this equivalence, driven by the technical comparisons of added receive channels and improved gradient performance.) | |
| No new potential hazards introduced | "Usage of the 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System does not result in any new potential hazards." |
| Support improved higher resolution imaging and shorter scan times | Indicated in the "Indications for Use" as a design goal: "designed to support improved higher resolution imaging and shorter scan times." While this is an "indication," the testing indirectly supports this through the improvements (eight independent receive channels and updated gradient amplifier performance) claimed to improve performance, although explicit quantitative measures of image resolution improvement or scan time reduction are not provided in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
This is not a clinical study involving a "test set" of patient data in the typical sense for AI/diagnostic algorithms. The evaluation described ("Summary of Studies") refers to engineering and performance testing against industry standards (NEMA, IEC) for the device itself. Therefore, concepts like sample size and data provenance (country of origin, retrospective/prospective) are not applicable in the context of this 510(k) summary. The "test set" would be the device under various operational conditions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since this is not a diagnostic algorithm dependent on human interpretation for its performance evaluation against a specific disease, the concept of "experts" establishing a ground truth for a test set is not applicable. The "ground truth" here is adherence to technical specifications and safety standards, determined through engineering measurements and tests.
4. Adjudication Method for the Test Set
As this is not a study involving human readers or a diagnostic "ground truth," an adjudication method is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided summary. This type of study typically assesses the diagnostic accuracy of human readers with and without an AI assistant. The 510(k) here is for a hardware modification to an MRI system, not an AI software.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study (algorithm only) was not done. This 510(k) is for a hardware medical device (MRI system), not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is based on engineering specifications, compliance with recognized performance standards (NEMA), and safety standards (IEC). These standards define the expected performance and safety characteristics of an MRI system. There is no mention of pathology, outcomes data, or expert consensus on clinical cases as the ground truth for this submission, as it relates to the device's fundamental operational characteristics.
8. The Sample Size for the Training Set
No "training set" is mentioned or implied. This is a submission for a hardware modification, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device modification.
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