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The ECHELON Synergy System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross sectional images that display the internal structure of the head, body, or extremities. The images produced by the 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 diagnosis determination.

Device Description

The ECHELON Synergy is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. The control and image processing hardware and the base elements of the system software are identical to the predicate device.

AI/ML Overview

This document describes the ECHELON Synergy MRI system's acceptance criteria and the studies conducted to demonstrate its performance. The submission for FDA 510(k) clearance (K251386) references a predicate device, the ECHELON Synergy MRI System (K241429), and outlines modifications to hardware and software.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against which a numeric performance metric is listed for each new feature. Instead, it details that certain functionalities (DLR Symmetry and AutoPose) underwent performance evaluations. The "performance" reported is described qualitatively or comparatively to conventional methods.

Feature/Metric	Acceptance Criteria (Implicit/Derived)	Reported Device Performance
DLR Symmetry - Artifact Reduction	Reduction of artifacts should be demonstrated.	Phantom testing demonstrated DLR Symmetry could reduce artifacts in the image using Normalized Root Mean Square Error (NRMSE). Clinical image review by radiologists indicated superior artifact reduction (p<0.05) compared to conventional images.
DLR Symmetry - Image Quality (SNR, Sharpness, Contrast, Lesion Conspicuity, Overall)	Should not degrade image quality compared to conventional methods. Images should be clinically acceptable.	Phantom Testing: Did not degrade image quality based on SNR, Relative Edge Sharpness, and Contrast Change Rate. Clinical Image Review: Radiologists reported superior SNR, image sharpness, lesion conspicuity, and overall image quality (p<0.05) in DLR Symmetry images. All DLR Symmetry images were evaluated as clinically acceptable.
AutoPose (Shoulder, Knee, HipJoint, Abdomen, Pelvis (male/female), Cardiac) - Automatic Slice Positioning	Should be able to set slice positions for a scan without manual adjustment in most cases. For remaining cases, user operation steps should be equivalent to manual positioning.	Evaluation by certified radiological technologists showed that "almost cases" were able to set slice positions without manual adjustment. The remaining cases required user operation steps equivalent to manual slice positioning.

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

DLR Symmetry:
- Clinical Image Test Set: 89 unique subjects (patients and healthy subjects).
- Data Provenance: From U.S. and Japan.
- Data Type: Retrospective (clinical images collected).
AutoPose:
- Shoulder: 60 cases
- Knee: 60 cases
- HipJoint: 65 cases
- Abdomen: 115 cases
- Pelvis for male: 60 cases
- Pelvis for female: 68 cases
- Cardiac: 126 cases
- Data Provenance: FUJIFILM Corp., FUJIFILM Healthcare Americas Corp., and clinical sites.
- Data Type: Subject type includes healthy volunteers and patients, implying a mix of prospective data collection for testing new features and potentially retrospective for some patient data.

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

DLR Symmetry:
- Number of Experts: Three US board certified radiologists.
- Qualifications: "US board certified radiologists." Specific years of experience are not mentioned.
AutoPose:
- Number of Experts/Evaluators: Three certified radiological technologists.
- Qualifications: "Certified radiological technologists." Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

DLR Symmetry: The document states that comparisons were made by "the reviewers" (plural) in terms of image quality metrics using a 3-point scale. It doesn't explicitly state an adjudication method like 2+1 or 3+1 if there were disagreements among the three radiologists. It implies a consensus or majority rule might have been used for the reported "superior" findings, but this isn't detailed.
AutoPose: The evaluation results are simply described as "evaluation results showed," implying a summary of the technologists' findings. No specific adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

DLR Symmetry: A form of MRMC study was conducted where three US board-certified radiologists reviewed images reconstructed with DLR Symmetry versus conventional methods.
Effect Size of Human Readers with AI vs. Without AI Assistance: The document indicates that images with DLR Symmetry (AI-assisted reconstruction) were "superior to those in the conventional images with statistically significant difference (p<0.05)" across various image quality metrics. This shows an improvement in the perceived image quality for human readers when using DLR Symmetry, but it does not quantify the "effect size of how much human readers improve with AI vs. without AI assistance" in terms of diagnostic performance (e.g., improved sensitivity/specificity for a given task). Instead, it focuses on the quality of the image presented to the reader.

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

DLR Symmetry: Yes, in part. Phantom testing was conducted to evaluate artifact reduction (NRMSE), SNR, Relative Edge Sharpness, and Contrast Change Rate. This is an algorithmic performance evaluation independent of human interpretation of clinical images, although it assesses image characteristics rather than diagnostic output.
AutoPose: The evaluation by certified radiological technologists focuses on the algorithm's ability to set slice positions automatically, which is a standalone performance metric for the automation function.

7. The Type of Ground Truth Used

DLR Symmetry:
- For phantom testing: "Ground truth" refers to the known characteristics of the phantom and metrics like NRMSE, SNR, etc.
- For clinical image review: The ground truth was established by expert consensus or individual assessment of the "clinical acceptability" of the images and comparative judgment (superiority) of image quality metrics by three US board-certified radiologists. This isn't pathology or outcomes data, but rather expert radiological opinion on image quality and clinical utility.
AutoPose: The "ground truth" was whether the automated positioning successfully set the slice positions without manual adjustment, as evaluated by certified radiological technologists.

8. The Sample Size for the Training Set

The document explicitly states regarding DLR Symmetry: "The test dataset was independent of the training and validation datasets." However, it does not provide the sample size or details for the training set (or validation set) for DLR Symmetry or AutoPose.

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

The document does not provide details on how the ground truth for the training set was established for either DLR Symmetry or AutoPose, as the training set details are not included in the provided text.

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