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

The Signa OpenSpeed Magnetic Resonance System is a modification to the Signa HFO/i Magnetic Resonance System (K992746) which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The Signa OpenSpeed Magnetic Resonance System is an open style magnet operating at 0.7T. 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 shorter scan times. Previously cleared software options, coils, and other accessories may be used with the Signa OpenSpeed Magnetic Resonance System.

This document is a 510(k) summary for the GE Signa OpenSpeed Magnetic Resonance System, which is a modification of an existing device. The summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study to prove performance against those criteria as would be done for a novel device or a device with significant performance claims requiring extensive clinical validation.

Based on the provided text, it's not possible to extract the detailed information requested in the prompt because the submission is for a modification of an existing device, and the evaluation relies on established safety and performance standards rather than a comparative effectiveness study with specific acceptance criteria for a new AI algorithm.

Here's an breakdown of why the requested information cannot be fully provided based on the input:

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

• Cannot be provided: The document states, "The Signa OpenSpeed Magnetic Resonance System was evaluated to the appropriate NEMA standard and performance criteria as well as International Medical Equipment Safety standard and performance criteria..." However, specific numerical acceptance criteria (e.g., sensitivity, specificity, image quality metrics) and reported performance values against these criteria are not detailed in this 510(k) summary. The evaluation focuses on compliance with established safety and performance standards for MR systems generally, not specific performance metrics against an AI-driven task.

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

• Cannot be provided: There is no mention of a "test set" in the context of evaluating a specific algorithm's performance on a dataset of patient images. The evaluation described is related to the physical and functional aspects of the MR system itself (gradient strength, slew rate, new imaging option).

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):

• Cannot be provided: No ground truth establishment mechanism is described as there is no specific performance validation related to interpreting images or making a diagnosis with an AI algorithm. The document mentions that images are interpreted by a "trained physician," but this refers to the standard medical practice of a human interpreting MR images, not the establishment of ground truth for an AI study.

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

• Cannot be provided: No adjudication method is mentioned as there's no test set or expert evaluation process described for an AI algorithm.

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:

• Cannot be provided: This document describes an MR system, not an AI algorithm intended for human-in-the-loop assistance. Therefore, no MRMC study or effect size for AI assistance is mentioned.

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

• Cannot be provided: This document relates to an MR imaging system, not a standalone AI algorithm.

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

• Cannot be provided: There is no mention of a ground truth for an AI algorithm's performance.

8. The sample size for the training set:

• Cannot be provided: As this is about an MR system modification, not an AI model, there is no concept of a "training set" in the context of this submission.

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

• Cannot be provided: No training set or ground truth establishment relevant to an AI algorithm is discussed.

Summary of Studies mentioned in the document:
The "Summary of Studies" section in the document states: "The Signa OpenSpeed Magnetic Resonance System was evaluated to the appropriate NEMA standard and performance criteria as well as International Medical Equipment Safety standard and performance criteria, comparable to the currently marketed Signa HFO/i Magnetic Resonance System."

This indicates that the studies performed were focused on demonstrating that the modified MR system meets established safety and performance standards generally applicable to MR equipment, and that its performance is comparable to the predicate device. This is typical for a 510(k) submission for a device modification where the primary goal is to show substantial equivalence and adherence to existing regulatory benchmarks, rather than to validate the performance of a new diagnostic algorithm using specific patient data.

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