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The GE Signa® MR Oncology Package is a patient positioning package intended for use with GE Signa® MR Systems.

The Signa® MR Oncology Package when used with a Signa® 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® MR system with Signa® MR Oncology Package 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, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® MR system with Signa® MR Oncology Package 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® MR Oncology Package provides an additional patient table for Signa® MR systems that allows patients to be imaged on a flat surface. The flat patient surface enables Signa® MR systems to acquire images in patient positions similar to other modalities that also utilize a flat patient surface such as X-Ray, CT, PET, and radiation therapy. The Signa® MR system with Signa® MR Oncology Package may also be used with MR-compatible patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions.

The GE Signa® MR Oncology Package includes a patient table that can be used with a GE Signa® MRcompatible patient positioning and immobilization devices. The Signa® Oncology Table is similar to the existing detachable patient table offered with Signa® MR Systems. It utilizes the detachable table system to offer a flat patient surface. The flat surface enables patients to be positioned similar to other diagnostic and therapeutic devices that also utilize flat patient surfaces. Also, the Signa® MR Oncology Package may be used with MR-compatible patient immobilization accessories to assist in consistent positions throughout multiple imaging sessions.

The GE Signa® MR Oncology Package is an accessory for existing GE Signa® MR Systems, primarily involving a modified patient table for oncology imaging. The provided 510(k) summary focuses on demonstrating substantial equivalence to its predicate device rather than presenting a detailed study with specific acceptance criteria related to diagnostic performance metrics like sensitivity or specificity for a standalone AI algorithm. It's a hardware modification intended to enhance positioning and imaging consistency.

Here's an analysis of the provided information:

1. Acceptance Criteria and Reported Device Performance

The document describes the device as an accessory and focuses on demonstrating that the modified table maintains the same imaging performance as the existing patient table with Signa® HDx MR System.

2. Sample Size for Test Set and Data Provenance

The document states "clinical image comparisons" were performed but does not specify the sample size (number of patients or images) used for these comparisons.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that it's a comparison study for a hardware modification, it's likely institutional data.

3. Number of Experts and Qualifications for Ground Truth

The document mentions "clinical image comparisons" and that images, when interpreted by a "trained physician," yield information that may assist in diagnosis. However, it does not specify the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the clinical image comparisons.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned in the provided text. The device is a patient positioning accessory, and the study focuses on its safety and equivalence in imaging performance, not on demonstrating an improvement in human reader performance with or without an AI assist.

6. Standalone (Algorithm Only) Performance

No standalone algorithm performance study was conducted or is applicable here. The device is a physical accessory (patient table) for an MR system, not an AI software algorithm.

7. Type of Ground Truth Used

The type of ground truth used for the clinical image comparisons is not explicitly stated beyond "images... when interpreted by a trained physician yield information that may assist in diagnosis." This implies a clinical diagnosis by a physician, but details like "expert consensus, pathology, or outcomes data" are not provided.

8. Sample Size for the Training Set

This information is not applicable. The device is a hardware accessory, not a machine learning model, so there is no "training set."

9. How Ground Truth for the Training Set Was Established

This information is not applicable. As mentioned above, there is no training set for this hardware device.

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