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MyoStrain software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements, viewing, image manipulations, communications, and printing. Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart. Tools are provided to display regional motion properties of the heart.

A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out of complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians to support the determination of a diagnosis.

The Myocardial Solutions Myostrain is software that runs on Windows-based operating systems to view and analyze SENC MR images of the heart in DICOM format. MyoStrain quantifies regional and global cardiac function from SENC images by implementing the SENC processing methods. With a friendly graphic user interface, users are able to analyze SENC MR images and obtain fast and reproducible measurements of myocardial strain, ejection fraction, and volumes. Measurements are collected presented on screen as a report showing values as colors and numbers, and this report can be printed or exported in digital format.

Here's a breakdown of the acceptance criteria and study details for MyoStrain 5.1 based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Note: The reported device performance for strain refers to phantom analysis, and the document explicitly states that the LOA measured in vivo in humans is unknown and could be different.

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

• Sample Size: N=23
• Data Provenance: Healthy subjects and patients. The document does not specify the country of origin or whether the data was retrospective or prospective.

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

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for the test set (the N=23 human subjects). Instead, it relies on comparison with existing, validated methods from a predicate device (Diagnosoft VIRTUE) for global measurements and a mechanical phantom for strain.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set. The validation of global measurements for the human subject data was done by comparing MyoStrain's measurements with those from Diagnosoft VIRTUE 5.51, which served as the "gold standard" for these specific metrics. For strain, a mechanical phantom with known actual strain values was used, which inherently provides its own "ground truth" without expert adjudication.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or reported in this document. The study described focuses on the standalone performance of the MyoStrain software compared to established methods/devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation of the algorithm was done. The "Accuracy of MyoStrain Measurements" section details the comparison of MyoStrain's outputs for LVEF, EDV, ESV, SV, and Mass against measurements from Diagnosoft VIRTUE 5.51 (considered the "gold standard" for these metrics). Similarly, strain accuracy was assessed using a mechanical phantom with known values. This demonstrates the performance of the algorithm itself, without human interpretation of its outputs being part of the primary performance metric.

7. The Type of Ground Truth Used

• For Global Measurements (LVEF, EDV, ESV, SV, LVMass): The ground truth was established by measurements from a legally marketed and established predicate device, Diagnosoft VIRTUE 5.51, which was considered the "gold standard" using traditional Cine MRI.
• For Strain Measurements (Phantom): The ground truth was established using a mechanical phantom with known actual strain values.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set for the MyoStrain algorithm. It only details the test set for performance evaluation.

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

The document does not provide information on how the ground truth for the training set was established. It focuses solely on the validation/test set.

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