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

The LVivoEF 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.

Here's a breakdown of the acceptance criteria and study details for the LVivo EF Software Application (K130779), based on the provided text:

Acceptance Criteria and Device Performance

The provided text only explicitly states one primary endpoint and the corresponding result. The exact acceptance criteria (i.e., the numerical threshold for success) are not explicitly stated, but the device's performance is reported to have met this primary endpoint.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 83 subjects.
   • Data Provenance: The text does not specify the country of origin of the data. It mentions "echocardiographic patient examination DICOM movies" and "ultrasound clips," implying clinical imaging data. The study is described as a "clinical trial," which typically implies prospective data collection, but it's not explicitly stated as prospective or retrospective.

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

   • The ground truth was established by "manual evaluation by sonographers and visual estimation by physicians." The number of sonographers or physicians is not specified, nor are their specific qualifications (e.g., years of experience).

3. Adjudication method for the test set:

   • The adjudication method is not explicitly stated. The text mentions "average values were calculated for each variable measured by Manual Biplane Method (MBP)," suggesting that multiple manual evaluations might have been averaged, but it doesn't detail a formal adjudication process (like 2+1 or 3+1).

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not reported. The study compared the device's performance against conventional manual methods performed by sonographers and physicians, but it did not assess human reader performance with versus without AI assistance.

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

   • Yes, a standalone study was performed. The "LVivoEF System" was evaluated against manual methods. The reported correlation coefficient (r=0.88) reflects the algorithm's performance in automatically calculating EF, which is a standalone assessment. The analysis was "fully automated."

6. The type of ground truth used:

   • The ground truth used was expert consensus/manual measurements. Specifically, it involved "manual evaluation by sonographers and visual estimation by physicians" using the "Manual Biplane Method (MBP)."

7. The sample size for the training set:

   • The document does not provide information about the sample size used for the training set.

8. 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, as the training set details are omitted.

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