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DiaCardio's LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular function evaluation. This measurement can be used to assist the clinician in a cardiac evaluation.

The LVivo System analyzes echocardiographic patient examination DICOM movies for Global ejection fraction (EF) evaluation. EF is evaluated using two orthogonal planes, four-chamber (4CH) and two-chamber (2CH) views, to provide fully automated analyses of LV function from the echo examination movies. It also has the ability to measure strain

Here's a breakdown of the acceptance criteria and study information for the LVivo Software Application, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on the performance of the LVivoSG module and its correlation with established methods rather than explicit "acceptance criteria" presented as pass/fail thresholds. However, we can infer the desired performance from the study objectives and results.

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

• Test Set Sample Size: 100 subjects (ultrasound clips of 100 subjects).
• Data Provenance: Retrospective, single-center study. Ultrasound examinations were collected prospectively according to protocol 100 rev 03 at "Soroka university medical center" (in Israel, based on the manufacturer's address).

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

• Number of Experts: At least two distinct groups of experts:
  • "Physicians of the echo department in Soroka university medical center" who routinely evaluated segmental wall motion qualitatively.
  • An "Additional investigator (expert echocardiologist)" who performed segmental strain evaluation using Syngo® Velocity Vector Imaging (VVI) SW (Siemens) blindly.
  • The "PI" (Principal Investigator) who evaluated examinations with impaired global LV function that lacked routine segmental WM scores.
• Qualifications of Experts:
  • "Physicians of the echo department" (implied to be qualified in echocardiography).
  • "Expert echocardiologist."
  • "PI" (implied to be an expert in echocardiography, given their role in evaluating complex cases).

4. Adjudication Method for the Test Set

The document describes several comparisons:

• LVivoSG WM evaluation was compared against "visual estimation" by physicians. This implies the physicians' visual estimation served as a form of ground truth or benchmark, rather than a formal adjudication of LVivoSG's output.
• LVivoSG longitudinal strain was compared against VVI, applied by an "additional investigator (expert echocardiologist)" blindly. This suggests the VVI measurements by this expert served as a reference.

There is no explicit mention of an adjudication method like 2+1 or 3+1 to establish a consensus ground truth amongst multiple experts for the test set itself. Instead, the study compares the device's performance against pre-existing routine evaluations (for WM) and expert-performed measurements using a predicate device (for strain).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?

No, a MRMC comparative effectiveness study where human readers improve with AI assistance vs. without AI assistance was not done.

The study's primary goal was to compare the performance of the LVivoSG system itself against established methods (manual methods, visual estimation, and a predicate device like VVI), not to evaluate the improvement of human readers using the AI. The device is described as a "decision support tool," implying assistance, but the study design doesn't measure this specific human-in-the-loop improvement.

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

Yes, a standalone performance study was done. The results reported (correlation coefficients, ICC, kappa, sensitivity, specificity, AUC) directly reflect the performance of the LVivoSG algorithms in automatically evaluating segmental wall motion and strain. The comparisons are between the LVivoSG's output and the ground truth/reference methods, without an intermediate human interaction being measured.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth was a combination of:

• Expert Visual Estimation: For segmental wall motion evaluation, the "routinely evaluated for segmental wall motion evaluation qualitatively by the physicians of the echo department."
• Expert-Applied Predicate Device Measurement: For segmental longitudinal strain, the ground truth was established by an "expert echocardiologist" using the Syngo® Velocity Vector Imaging (VVI) SW (Siemens), a recognized predicate technology.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It only mentions the "100 subjects" used for the clinical trial (test set) for the LVivoSG.

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

Since the training set size and characteristics are not provided, how the ground truth for the training set was established is also not described in this document.

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