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The GE Signa® HDe 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® HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, 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 body. The images produced by the Signa® HDe 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 1.5T Signa® HDe MR systems are a modification to the previously cleared MR systems K052293 which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The 1.5T Signa® HDe Magnetic Resonance System features a superconducting magnet operating at 1.5T. The data acquisition system supports 1, 4, 8 independent receive channels and multiple independent coil elements per channel during a single acquisition series. 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. The 1.5T Signa® HDe MR system is also compatible in a mobile configuration.

The provided document is a 510(k) summary for the GE 1.5T Signa HDe MR System. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not include detailed studies with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert information typically associated with AI/ML device evaluations.

This document is for an MR system, a hardware device, and not an AI/ML software device. Therefore, the questions related to AI/ML specific evaluation metrics (sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable to the information provided in this 510(k) summary.

The summary references evaluation to NEMA performance standards and IEC 60601-1 safety requirements, which are typical for hardware medical devices. These standards would have their own established acceptance criteria for various physical and electrical performance parameters, as well as safety, but the specific details of these criteria and the reported performance are not included in this high-level summary.

Based on the provided text, I can extract the following limited information:

1. A table of acceptance criteria and the reported device performance:

Specific acceptance criteria and reported performance metrics in quantitative terms are not available in the provided 510(k) summary. The summary generally states that the device was "evaluated to the appropriate NEMA performance standards as well as the IEC 60601-1 International Medical Equipment Safety requirements" and concludes that the device is "substantially equivalent" to its predicate device. This implies that it met implicit performance and safety criteria relevant to an MR system.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable/not provided. This document is for an MR hardware system, not an AI/ML software where a test set of data would be evaluated.
• Data Provenance: Not applicable/not provided. The evaluation focuses on the hardware's adherence to engineering standards and safety.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth establishment by experts for image interpretation is not relevant for the evaluation of an MRI hardware system as described in this 510(k) summary.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are typically for evaluating diagnostic accuracy of interpretations, which is not the focus of this MR system's 510(k).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. For hardware, "ground truth" would relate to physical measurements and engineering specifications, not clinical diagnostic accuracy based on patient data.

8. The sample size for the training set:

Not applicable. There is no AI/ML model for which "training set" would apply.

9. How the ground truth for the training set was established:

Not applicable.

In summary, the provided 510(k) documentation for the GE 1.5T Signa HDe MR System focuses on demonstrating substantial equivalence to a predicate MR system based on design modifications and compliance with established performance and safety standards for hardware. It does not contain the types of studies or data points typically associated with the evaluation of AI/ML software devices.

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