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The Signa® Profile EXCITE MR system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa® Profile EXCITE MR 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 musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa® Profile EXCITE MR 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® Profile EXCITE MR system may also be utilized for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.

Signa® Profile EXCITE MR System is a modification to the 0.2T Signa® Profile/i MR System (K033168) which utilizes a permanent magnet to acquire 2D single-slice and multi-slice, and 3D volume images. 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

This document is a 510(k) summary for the GE Signa® Profile EXCITE MR System, submitted in 2004. It describes a modification to an existing MR system and focuses on demonstrating substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria or detailed device performance in a table format as might be expected for a machine learning or AI device. Instead, it relies on demonstrating compliance with established performance standards for Magnetic Resonance (MR) systems.

• IEC 60601-1 International Medical Equipment Safety standard
• IEC 60601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis | The Signa® Profile EXCITE MR System was evaluated and found to comply with the specified safety standards. The conclusion states, "Usage of the Signa® Profile EXCITE MR System does not result in any new potential hazards." |
  | Performance Standards | Compliance with appropriate NEMA (National Electrical Manufacturers Association) performance standards for MR systems. (Specific NEMA standards are not listed but are implied as "appropriate" for an MR system.) | The Signa® Profile EXCITE MR System was evaluated to the "appropriate NEMA performance standards." Implied performance is comparable to the predicate device, as the submission aims to show "substantial equivalence." |
  | Substantial Equivalence to Predicate Device | Key differences (EXCITE technology, changed data acquisition hardware, new software version, gradient power supply) do not introduce new safety concerns or alter fundamental performance characteristics such that the device is no longer equivalent for its intended use. | The device is deemed "substantially equivalent to the currently marketed the 0.2T Signa® Profile/i MR system (K033168)." The changes enable "maximum gradient slew rate changes to 34 T/m/s with maximum hardware capability of 46 T/m/s," and maintain a maximum gradient amplitude of 19 mT/m, indicating performance improvements within the scope of the predicate. |
  | Intended Use | The device should be able to produce diagnostic images for the specified body parts and systems, and be usable for interventional procedures with MR compatible devices. | The device 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 musculoskeletal, vascular, cardiac, and neuro systems." It can also be "utilized for imaging during interventional procedures." |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided document describes a medical device (MR System), not an AI/machine learning algorithm that uses a "test set" in the computational sense. The evaluation is based on compliance with established engineering and medical device safety and performance standards (NEMA, IEC) and comparison to a predicate device. Therefore, there is no specific "test set" of patient data or images described in this summary. The evaluation focuses on the hardware and software modifications and their adherence to regulated standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As this is not an AI/ML device relying on image interpretation for its primary function, there is no "ground truth for a test set" in the context of expert review of images to train or validate an algorithm. The "ground truth" for an MR system's performance is its ability to produce images that meet physical and technical specifications and allow for diagnostic interpretation by a trained physician (as stated in the Indications for Use).

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

Not applicable. No test set of images requiring expert adjudication is described.

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 device is an MR imaging system, not an AI-assisted diagnostic tool for image interpretation. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.

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

Not applicable. This is not an algorithm; it is a physical imaging device.

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

Not applicable in the context of evaluating a software algorithm. For an MR system, the implicit "ground truth" of its performance is its ability to acquire images that accurately represent the physical properties of the body (proton density, T1, T2, flow) as confirmed by physical phantom measurements and clinical observation, which are then used by trained physicians for diagnosis.

8. The sample size for the training set

Not applicable. This device is a hardware/software system, not an AI/ML algorithm that is "trained" on a dataset of patient images.

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

Not applicable. No training set is described for this device.

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