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LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.

The LVivio IQS is an extension to the LVivio IQS (K222970), as an additional Algorithm with API that will be able to provide a Quality Score in real time to the Right Ventricle from the 4-chamber apical view of the heart. In addition, the LVivo IQS will be provided as a software component to be integrated by another computer programmer into their legally marketed ultrasound imaging device. Essentially, the Algorithm and API, which is a module, is a medical device accessory.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The device is an extension to the LVivo IQS (K222970) that provides a Quality Score in real-time to the Right Ventricle (RV) from the 4-chamber apical view of the heart. The acceptance criteria focus on the agreement of the device's quality scoring with expert assessment and the clinical interpretability of images deemed "Medium" or "Good" quality by the device.

Study Details

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

   • Study 1: 100 patient examinations were used for validation. A total of 49,623 frames were analyzed. Data acquisition was done with "different ultrasound devices and various cardiac pathologies." The source country of the data is not explicitly stated, nor is whether the study was retrospective or prospective, though the mention of "already data acquired" suggests a retrospective approach for this specific test.
   • Study 2: 182 patients were included in the study. This study involved "data acquired after using the LVivo IQS in real time while scanning the RV from the 4CH apical view." This indicates a prospective data collection directly utilizing the device. The data was gathered in a "Point of Care environment." The country of origin is not specified.

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

   • Study 1: "Experienced sonographer" (singular, though it might imply multiple, the text only states "sonographer"). No specific number or years of experience are provided, but the term "experienced" implies relevant qualifications.
   • Study 2: "Three expert cardiologists specializing in echo." No specific years of experience are listed, but "expert" implies high-level qualification in the field.

3. Adjudication method for the test set:

   • Study 1: Not explicitly stated, as it refers to "data tagging by experienced sonographers." This suggests a direct comparison to the sonographer's quality assessment.
   • Study 2: For clinical interpretability, the judgment was made "by the majority of three expert cardiologists specializing in echo." This indicates a majority vote (e.g., 2 out of 3 agreement).

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:

   • A formal MRMC study comparing human readers with and without AI assistance is not explicitly described. The studies primarily validate the device's standalone performance or its real-time use in conjunction with human actions (Study 2, where doctors documented scores). The studies focus on the device's ability to provide a consistent and clinically relevant quality score, rather than directly measuring reader improvement with AI assistance.

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

   • Study 1 serves as a standalone performance evaluation by comparing the device's output to an experienced sonographer's quality tagging on pre-existing data (i.e., the algorithm processes images and outputs a score, which is then compared).
   • Study 2 involves the device being used in "real time while scanning," indicating a human-in-the-loop scenario where the device provides feedback during the acquisition process. However, the evaluation of clinical interpretability after the fact (by the expert cardiologists) can be seen as an assessment of the output generated by the combination of the device and the acquisition process it influenced.

6. The type of ground truth used:

   • Study 1: "Quality tagging by experienced sonographers." This is expert consensus/opinion on image quality.
   • Study 2:
     • For the device's real-time quality score (criteria 'a'), the ground truth was the "visual estimation" via "ACEP score (1-5)" made by the medical doctors during acquisition. This represents user-reported quality.
     • For clinical interpretability (criteria 'b'), the ground truth was "clinically interpretable by the majority of three expert cardiologists specializing in echo." This is expert clinical interpretation/consensus.

7. The sample size for the training set:

   • The document does not specify the sample size for the training set. It only describes the validation/test sets.

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. It only discusses the ground truth for the validation/test sets. The algorithm is described as "AI based," which implies a training phase, but details are omitted.

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LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.

The LVivio IQS is an extension to the LVivio Software Application (K210053), as an additional Algorithm with API that will be able to provide a Quality Score in real time to the Left Ventricle from the 4 chamber apical view of the heart. In addition, the LVivo IQS will be provided as a software component to be integrated by another computer programmer into their legally marketed ultrasound imaging device. Essentially, the Algorithm and API, which is a module, will be a medical device accessory. The QIS Meter concept is similar to the legally marketed Caption Guidance Software Device.

Acceptance Criteria and Device Performance for LVivo IQS

The LVivo IQS device was evaluated through two performance studies. Below is a summary of the acceptance criteria and the reported device performance, along with details of the studies.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

Retrospective Study (Agreement with Experienced Sonographer):

• Sample Size (Test Set): 100 patient examinations (22,663 frames)
• Data Provenance: Data was "already acquired with different ultrasound devices and various cardiac pathologies." The document does not specify the country of origin.
• Retrospective/Prospective: Retrospective.

Prospective Study (POC Interns & Expert Echocardiologist):

• Sample Size (Test Set): 64 patients
• Data Provenance: Data acquired after using the LVivo IQS in real-time by POC interns in a POC environment. The document does not specify the country of origin.
• Retrospective/Prospective: Prospective.

3. Number of Experts and their Qualifications (Ground Truth for Test Set)

Retrospective Study:

• Number of Experts: Not explicitly stated, but refers to "experienced sonographer" (singular or plural not clear from the text, but implies a consensus or single expert for tagging each case).
• Qualifications: "experienced sonographer." No further details on years of experience or certification are provided.

Prospective Study:

• Number of Experts: At least one "expert echocardiologist."
• Qualifications: "expert echocardiologist." No further details on years of experience or certification are provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1) for either study.

• Retrospective Study: Implies a direct comparison of LVivo IQS results against "quality tagging by experienced sonographer," suggesting a single "expert" assessment served as the ground truth without further multi-reader adjudication.
• Prospective Study: The "clinical interpretability" was determined by an "expert echocardiologist," again suggesting single expert assessment rather than a multi-reader adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or performed according to the provided text. The studies focus on the performance of the LVivo IQS directly against expert assessment or clinical interpretability.

6. Standalone (Algorithm Only) Performance

Yes, standalone performance was done. The studies explicitly evaluate the LVivo IQS system's performance.

• The Retrospective Study directly compares the algorithm's output ("LVivo IQS results") with expert quality tagging.
• The Prospective Study assesses the "quality score by LVivo IQS" and the subsequent "clinical interpretability" of clips identified by the system as having sufficient quality.

7. Type of Ground Truth Used

• Retrospective Study: Expert Consensus/Tagging. The ground truth was established by "quality tagging by experienced sonographer(s)."
• Prospective Study: Expert Clinical Interpretability. The ground truth for clinical utility was established by "expert echocardiologist" interpreting the saved clips. Initial quality (3-5) was based on visual estimation, presumably by POC interns.

8. Sample Size for the Training Set

The document does not report the sample size for the training set. It only describes the validation/test sets for performance evaluation.

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

Given that the sample size for the training set is not reported, the method for establishing ground truth for the training set is also not described in the provided text.

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