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suiteHEART is an analytical software tool. which provides reproducible tools for the review and reporting of medical images. suiteHEART can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization.

A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point, distance, area, and volume measurement tools such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements.

Semi-automatic tools are available for left ventricular contour detection, valve plane detection, vessel contour detection for flow analysis, signal intensity analysis for myocardium and infarct sizing measurement, and T2 star analysis.

The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.

When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.

suiteHEART is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. suiteHEART can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in cine mode to facilitate visualization.

Measurement tools on the report interface include: point, distance, area, and volume measurements (including ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements). Semi-automatic tools are available for left ventricular contour detection, valve plane detection, vessel contour detection for flow analysis, signal intensity analysis for myocardium and infarct sizing measurement, T2 Star analysis, and patent foramen ovale (PFO) analysis.

The provided text states that suiteHEART is an analytical software tool that offers reproducible tools for reviewing and reporting medical images. It can import medical images from an MR system and display them. According to the document, semi-automatic tools are available for several medical measurements.

Here's an analysis of the provided information:

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

The provided text does not explicitly state specific acceptance criteria with numerical targets or reported performance metrics for the suiteHEART device regarding its semi-automatic tools (e.g., accuracy, sensitivity, specificity, or inter-reader variability improvement). The document focuses on regulatory compliance and substantial equivalence to a predicate device, rather than detailed performance benchmarks.

The summary of non-clinical tests mentions "Performance testing (Verification)" as a quality assurance measure, but the specifics of this performance testing or its results against defined criteria are not detailed.

2. Sample size used for the test set and the data provenance

• Sample Size: The document states that "The MR acquired clinical images that were used for the completion of verification and validation testing for suiteHEART was obtained from East Side Medical Radiology, LLC and other third-party facilities under the provisions of a nonsignificant risk investigation for internal volunteer scanning. In addition, multi-vendor anonymized MR contrast-enhanced images were obtained from a third-party clinical research study."
  • However, a specific numerical sample size for the test set is not provided.
• Data Provenance:
  • Images from "East Side Medical Radiology, LLC and other third-party facilities."
  • Images were obtained "under the provisions of a nonsignificant risk investigation for internal volunteer scanning." This suggests a prospective collection of data, likely of healthy volunteers or patients undergoing scans for other reasons, with their consent.
  • "multi-vendor anonymized MR contrast-enhanced images were obtained from a third-party clinical research study." This implies a retrospective collection from existing studies, anonymized, and from multiple vendors, indicating diversity in the data.
  • The country of origin is not explicitly stated, although the submitter is based in Pewaukee, WI, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The text does not detail the process of establishing ground truth for the test set images, nor does it mention the number or qualifications of experts involved in this process.

4. Adjudication method for the test set

This information is not provided in the document. There is no mention of an adjudication method (e.g., 2+1, 3+1, none) used to establish ground truth or resolve discrepancies in the test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: The document does not explicitly state that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The device description primarily focuses on the tool's features and its use by a physician for interpretation, rather than its impact on human reader performance in a controlled study.
• Effect Size: Consequently, no effect size or data on human reader improvement with vs. without AI assistance is provided. The statement "When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis" suggests assistive capability but not quantified improvement in a comparative study.

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

The document describes suiteHEART as an "analytical software tool" that provides "reproducible tools for the review and reporting of medical images" and specifically states that "The results of the measurement tools are interpreted by the physician." This indicates that the device is intended for human-in-the-loop performance. While the semi-automatic tools perform tasks like contour detection, the final interpretation and diagnosis are explicitly placed with the physician. Therefore, a standalone (algorithm only) performance assessment, independent of human interpretation, is not described or implied as a primary evaluation method for regulatory submission.

7. The type of ground truth used

The document does not explicitly state the type of ground truth used for the semi-automatic features. For example, it does not specify whether ground truth for ventricular contours or infarct sizing was established by expert consensus, comparison to another imaging modality (e.g., gold standard MRI sequences), or pathology.

8. The sample size for the training set

The document does not provide a specific sample size for the training set. It only mentions the source of images for "verification and validation testing." Typically, training set information is distinct from test set information, and it's not detailed here.

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

Since the document does not specify the training set or its sample size, it also does not explain how the ground truth for any potential training set was established.

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