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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 of patients and Age >18.

The LVivo Seamless is a standalone application that extends the LVivo Platform and runs offline on a server in a healthcare environment. The system accepts echo examinations in DICOM format that are sent from an Ultrasound device and automatically selects the adequate clips for EF and GLS evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF and LVivo Strain modules which perform automatic EF and Strain evaluation or EF and Strain analysis by FDA cleared 30d party software. The results are sent to the PACS and are evaluated by a healthcare professional.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) submission summary for LVivo Seamless:

1. Table of Acceptance Criteria and Reported Device Performance

Note: While the "85% processed automatically" criterion was reported as 84% met, the FDA cleared the device, implying this slight discrepancy was acceptable, or perhaps the 84% refers specifically to the subset used for correlation analysis rather than automated processing success rate on all 166 exams. The document states "The analysis (...) results are provided for 139 exams (84%) in which the system correctly identified 4, 2 and 3 chamber views," which further implies 84% of the total 166 (139/166 = 83.7%) and this subset was then used for the correlation analyses.

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

• Test Set Sample Size: 166 examinations (images/videos) were included in the validation. Analysis results for EF and GLS correlations were provided for 139 exams (84% of the total 166) where the system correctly identified all three heart chamber views (4, 2, and 3 chamber).
• Data Provenance: The documents do not explicitly state the country of origin. However, the manufacturer is DiA Imaging Analysis Ltd (Beer-Sheva, Israel), suggesting the data could be from various international sources, potentially including Israel. The study type is not explicitly stated as retrospective or prospective, but given it's a validation study for an existing (modified) device, it's highly likely to be retrospective data collected from clinical archives.
  • Sub-datasets based on equipment:
    • 71 exams: Acquired with EPIQ (Philips Healthcare).
    • 96 exams: Acquired with Vivid E95 (74%), Vivid S70 (12.5%), Vivid E9 (12%) (GE Healthcare).

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth. It refers to "Ground Truth Biplane EF measurements" and "Ground Truth GLS measurements," implying expert consensus or established clinical measurements were used. It is standard practice in such studies for ground truth to be established by qualified cardiologists or echo sonographers.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (like 2+1 or 3+1). It states "Ground Truth" was established, which usually implies a single consensus reading or a process where discrepancies are resolved, but the specific process is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described. The study focused on demonstrating the device's performance against established ground truth measurements, not on how human readers' performance improved with or without AI assistance.

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

Yes, a standalone performance evaluation was done. The reported performance metrics (correlation, Bland-Altman) are directly comparing the device's automated measurements (algorithm only) to the established ground truth. The description of "LVivo Seamless activates the FDA cleared LVivo EF and LVivo Strain modules which perform automatic EF and Strain evaluation" further supports this.

7. The Type of Ground Truth Used

The ground truth used was expert consensus/established clinical measurements for Biplane EF (Ejection Fraction) and GLS (Global Longitudinal Strain). The clinical context implies these values were derived from manual, expert measurements or calculations based on the ultrasound images, intended to be the gold standard against which the device's automated measurements were compared.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. This submission focuses on the validation of the device's performance, not its development or training process.

9. 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. Similar to point 8, this is typically part of the device development phase and not detailed in a 510(k) summary for validation.

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