Search Results

The GE Signa® Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa® Infinity System is indicated for use as a diagnostic imaging device to produce transverse, 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, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® Infinity systems 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® 3.0T Infinity TwinSpeed with Excite Magnetic Resonance System is a modification to the Signa® 3.0T Magnetic Resonance System (K022397) which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The Signa® 3.0T Infinity Twin Speed with Excite Magnetic Resonance System features a superconducting magnet operating at 3.0T. 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.

The provided text is a 510(k) summary for the GE 3.0T Signa® Infinity TwinSpeed with Excite Magnetic Resonance System. It does not describe acceptance criteria, device performance results, or a clinical study in the format requested. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot extract the detailed information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes, expert qualifications, or details about comparative effectiveness studies, because this information is not present in the provided document.

The document states that the system "was evaluated to the appropriate NEMA performance standards as well as 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." However, it does not provide the specific acceptance criteria from these standards or the results of those evaluations. It also clarifies that the key differences from the predicate device are additional receive channels, a dual-mode gradient coil, and changes to magnet dimensions, suggesting an engineering upgrade rather than a performance-based clinical study seeking acceptance criteria fulfillment.

Ask a specific question about this device

The Signa Magnetic Resonance System is a whole body scanner. The Signa Magnetic Resonance 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 or body. The images produced by the Signa 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.

ASSET (Array Spatial Sensitivity Encoding Technique) is an image reconstruction technique used in A conjunction with phased array coils in which the number of phase encode steps is reduced by increasing the distance between steps, or equivalently, by reducing the field of view. Aliasing or wrapping caused by the object extending outside the reduced field of view is eliminated using knowledge of the B1 fields of the coils.

The provided 510(k) summary for the GE Signa ASSET Imaging Option primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the reconstruction technique. It does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the typical elements of a modern AI/device performance study.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission states "Evaluation testing was done to verify the performance of the option," but it does not specify what those performance metrics were, what the acceptance criteria were, or the results of that evaluation.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided in the document. The ASSET Imaging Option is described as an image reconstruction technique, not an AI-assisted diagnostic tool for human readers in the way modern AI devices are studied.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The document does not describe a standalone performance study in the modern sense of an algorithm making diagnostic interpretations without human intervention. The ASSET Imaging Option is a component of a diagnostic imaging system, designed to produce images that are then "interpreted by a trained physician" to aid in diagnosis.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

This information is not provided in the document. Given the description, any "ground truth" would likely relate to the accuracy of the image reconstruction itself rather than diagnostic accuracy.

8. The Sample Size for the Training Set

This information is not provided in the document. The ASSET option is a reconstruction technique, and while it involves software, the concept of a "training set" in the context of machine learning as understood today is not applicable or discussed in this submission from 2001.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document, as the concept of a training set and its ground truth is not elaborated upon for this type of device and submission from 2001.

Summary of the Study Mentioned in the Document:

The document states: "The ASSET Imaging Option was developed in conformance with design control requirements as specified in 21 C.F.R. 820.30. Software hazard analysis and verification test procedures were completed. Evaluation testing was done to verify the performance of the option."

This indicates that standard design control and verification/validation activities were performed, as required for medical devices. However, the details of these tests (e.g., acceptance criteria, sample sizes, specific performance metrics, and results) are explicitly omitted from this 510(k) summary, as was common practice for submissions of this era, especially for modifications to existing predicate devices related to image acquisition/reconstruction rather than novel diagnostic algorithms. The primary "study" presented is a comparison to predicate devices, asserting substantial equivalence based on intended use and operating modes.

Ask a specific question about this device