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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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