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MR Elastography is an optional package for Canon Medical Systems magnetic resonance imaging (MRI) systems. This option allows the user to obtain an image that reflects the stiffness, in kPa, of body tissue such as liver and muscle.

MR Elastography is an optional package for Canon Medical Systems magnetic resonance imaging (MRI) system. This option allows the user to obtain an image that reflects the stiffness of body tissue.

MR Elastography consists of Acoustic Driver System including Active Driver, Passive Driver, QA Phantom and Other parts, TTL trigger converter includes AC adaptor, Manuals and Software (License).

By MRI scanning while applying vibration from the Acoustic Driver System, it is possible to obtain an image that reflects the stiffness of the body tissue in kPa. The sequence to be used with Acoustic Driver System is FE2D or SE-EPI2D. The MRI scanner outputs the following images from the acquired phase image and magnitude image.

• · Wave image
• · Stiffness image (capable of registration and display in color image format)
• · Confidence image (capable of superimposing confidence image on the stiffness image)

The provided text describes the 510(k) submission for Canon Medical Systems' MR Elastography (MZEK-001A) device. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text states: "The phantoms were scanned 5 times per day, multiple days per scanner, on 2 different 1.5T and 2 different 3T scanners by FE2D and SE-EPI2D techniques."

• Test Set Sample Size: While an exact number of "scans" isn't explicitly given beyond "5 times per day, multiple days per scanner," it indicates a sufficient number of measurements across different scanner types (2x 1.5T, 2x 3T) and scanning techniques (FE2D, SE-EPI2D). The total number of individual phantom measurements would be 5 (scans/day) * X (days) * 4 (scanners) * 2 (techniques). The document implies a robust bench testing setup rather than patient data.
• Data Provenance: The data appears to be from prospective bench testing conducted by Canon Medical Systems, likely in a controlled laboratory environment. The country of origin of the data is not specified, but given the manufacturer is Japan and the US agent is in the US, the testing could have occurred in either location or a combination. The data is synthetic (phantom-based) rather than clinical patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable/not mentioned. The ground truth was established using "Resoundant-provided calibration phantoms having known stiffness values." This indicates a physical phantom with pre-calibrated, known stiffness properties, rather than expert interpretation of images.
• Qualifications of Experts: Not applicable, as expert interpretation was not used for ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not mentioned. Since the ground truth was based on physical phantoms with known stiffness values, there was no need for expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. The study focused on the device's ability to accurately measure stiffness against known phantom values, not on human reader performance or improvement with AI assistance.

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

• Standalone Performance: Yes, the described testing is akin to a standalone (algorithm only) performance evaluation. The device (hardware and software) outputs stiffness values based on the acquired data, and these values are compared directly against the known stiffness of the phantoms. There is no mention of human interpretation being part of this core performance evaluation. The output stiffness image and confidence image are for user display, but the performance metrics are system-derived.

7. The Type of Ground Truth Used

• Ground Truth Type: The ground truth used was phantom-based with known stiffness values. Specifically, "three Resoundant-provided calibration phantoms having known stiffness values representing the expected clinical range."

8. The Sample Size for the Training Set

• Training Set Sample Size: The document does not provide details on the sample size of any training set. It describes the performance testing of the final device. The software was "based on an estimation algorithm provided by the Mayo Clinic and Resoundant, Inc." and "developed in conjunction with The Mayo Clinic and Resoundant, Inc.," suggesting external development and/or collaboration, but no specifics on training data are given.

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

• Training Set Ground Truth Establishment: The document does not provide details on how the ground truth for any training set was established. Given the software's origin from Mayo Clinic and Resoundant, Inc., it's plausible they used a combination of phantom data and potentially de-identified clinical data with histopathological correlation for development and training, but this is speculative based on common practice for such devices and not explicitly stated in the provided text.

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