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The GE Signa® 3.0T with Excite is a whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa® 3.0T with Excite MR System is indicated for use as a diagnostic imaging device to produce transverse, saqittal, 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® 3.0T with Excite MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic These images and/or spectra when interpreted by a trained physician yield resonance. information that may assist in diagnosis.

The GE Signa 3.0T 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 GE Signa® 3.0T 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 510(k) summary for the GE Signa® 3.0T with Excite Magnetic Resonance System (K040444) does not contain the detailed information requested regarding acceptance criteria, device performance metrics, or specific study designs with sample sizes, ground truth establishment, or expert involvement.

This submission is a "Substantially Equivalent" determination for a modification to an existing device (Signa® 3.0T MR system, K022397). The primary difference is the addition of eight independent receive channels as part of a system upgrade.

Here's what can be extracted based on the provided document and why other information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The Signa® 3.0T with Excite MR 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."

• Acceptance Criteria: While the standards are named (NEMA, IEC 601-1, IEC 601-2-33), the specific acceptance criteria values (e.g., minimum signal-to-noise ratio, maximum image distortion) are not listed in this 510(k) summary. These standards define various performance metrics for MR systems, and the device would have to meet the specified thresholds within those standards.
• Reported Device Performance: The document only makes a general statement: "The Signa® 3.0T with Excite MR System is comparable to the currently marketed Signa® 3.0T Magnetic Resonance System." It does not provide specific numerical performance results from the evaluations against NEMA or IEC standards.

Therefore, a table with specific acceptance criteria and reported numerical performance cannot be constructed from this document.

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

• Sample Size: The document does not specify a sample size for a "test set" in the context of clinical or image-based performance evaluation. The evaluation appears to be primarily technical validation against engineering standards rather than diagnostic accuracy studies involving patient data.
• Data Provenance: Not applicable, as human data for a test set is not described.

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

• Number of Experts: Not applicable, as there is no mention of a test set with human-interpreted ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Not applicable, as there is no mention of a test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• MRMC Study: The document does not describe any MRMC comparative effectiveness study. This type of study would typically compare diagnostic performance with and without the new feature (e.g., the 8 independent receive channels) and involve multiple human readers.
• Effect Size: Not applicable, as no MRMC study is reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• The GE Signa® 3.0T with Excite is a Magnetic Resonance Diagnostic System, not an AI algorithm. Standalone performance, in the context of AI, refers to the algorithm's performance without human input. This concept does not apply directly to an MR imaging system. The "performance" described would be technical image quality and safety assessments.

7. The Type of Ground Truth Used:

• Based on the statement, "The Signa® 3.0T with Excite MR 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," the "ground truth" for the evaluation would be engineering and technical specifications and measurement protocols defined by these international standards. This would involve phantom studies and technical measurements rather than clinical ground truth (like pathology or outcomes data).

8. The Sample Size for the Training Set:

• Not applicable. This is an MR imaging device, not an AI algorithm that requires a "training set" of data in the machine learning sense. The development and testing would involve engineering and physics principles.

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

• Not applicable, as there is no training set for an AI algorithm.

In summary, the 510(k) K040444 is a substantial equivalence submission for a hardware modification to an existing MR system. The evaluation primarily relies on demonstrating compliance with established engineering and safety standards (NEMA, IEC) rather than clinical performance studies involving patient data, expert interpretation, or AI algorithm validation.

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