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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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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 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 evaluation. The results are sent to the PACS and are evaluated by a healthcare professional.

Here's a breakdown of the acceptance criteria and study details for the LVivo Seamless v2.0 device, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 100 patient examinations.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It mentions "measurements done routinely in the Echo lab by AFI," which suggests retrospective use of existing clinical data.

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

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").
It states that "The measurements by LVivo Strain running offline on the automatically selected clips were compared to the measurements done routinely in the Echo lab by AFI." This implies that the ground truth was established by the "AFI" system (Automated Functional Imaging, GE), which is a commercially available and presumably validated automated measurement tool, as part of routine clinical practice. Since these were routine measurements, they would have been interpreted and validated by qualified medical professionals (e.g., sonographers, cardiologists) in the echo lab. However, the exact process of how the AFI measurements were considered "ground truth" (i.e., whether they were subject to expert review for this study) is not detailed.

4. Adjudication Method for the Test Set

The document does not mention a specific adjudication method (e.g., 2+1, 3+1). The comparison was made between the device's measurements and measurements performed by the AFI system as part of routine lab procedures.

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 done. The study described compares the algorithm's performance against an existing automated system (AFI) for GLS measurements and view identification. It does not evaluate the improvement of human readers with AI assistance.

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

Yes, a standalone study was done. The performance evaluation compares the LVivo Seamless v2.0 device's automated capabilities (view recognition and GLS measurement) directly against another automated system (AFI) and against predefined acceptance criteria for view identification. There is no mention of human readers interacting with the device for the purpose of this performance evaluation. The device "runs offline on a server" and "automatically selects the adequate clips for EF and GLS evaluation."

7. The Type of Ground Truth Used

The ground truth for the GLS measurements was established by comparing the LVivo Seamless results to "measurements done routinely in the Echo lab by AFI" (Automated Functional Imaging, GE). For the view identification, the ground truth is implicitly based on the actual presence of 4CH, 2CH, and 3CH views in the patient examinations, likely determined by human assessment during the initial acquisition and processing of the images in the echo lab.

8. The Sample Size for the Training Set

The document does not provide the sample size used for the training set. It focuses solely on the performance evaluation using the test set.

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, as the details of the training process are not included in this summary.

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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.

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 evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF module which performs automatic evaluation. The results are sent to the PACS and are evaluated by a healthcare professional.

Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and the supporting study:

The provided document describes the LVivo Seamless device, a standalone application that extends the LVivo Platform for processing ultrasound images. The key function highlighted is the automatic selection of clips for EF (Ejection Fraction) evaluation and then applying the FDA-cleared LVivo EF module for automatic evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative, pass/fail format for the LVivo Seamless's performance relative to a specific metric. Instead, it relies on demonstrating substantial equivalence to a predicate device (K200232 LVivo Software Application). The performance evaluation is summarized as having "demonstrated conformity to intended use" based on "well-established test methods."

Therefore, I cannot populate a table with specific acceptance criteria and reported numerical performance for the LVivo Seamless itself. The performance is assessed by its similarity to the predicate and the general statement of conformity.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance Evaluation" based on "well-established test methods."

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not specify any adjudication method used for the test set.

5. 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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The focus is on the device's standalone performance in relation to the predicate.

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

Yes, a standalone performance assessment was conducted for the LVivo Seamless. The description states: "The system accepts echo examinations in DICOM format that are sent from an Ultrasound device and automatically selects the adequate clips for EF evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF module which performs automatic evaluation." This indicates the algorithm's performance without direct human intervention in the interpretation process. The results are then sent to PACS for evaluation by a healthcare professional, implying the initial automated steps are standalone.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used. Given the context of "EF evaluation" and "automatic evaluation," it's highly probable that the ground truth for the underlying LVivo EF module (which the LVivo Seamless activates) would have been established through expert consensus by cardiologists or sonographers reviewing and measuring Ejection Fraction on the ultrasound images. However, this is an inference and not explicitly stated for the LVivo Seamless's specific performance evaluation.

8. The sample size for the training set

The document does not specify the sample size for the training set.

9. How the ground truth for the training set was established

The document does not specify how the ground truth for the training set was established.

Summary of what's provided for LVivo Seamless (K202546):

The submission focuses heavily on demonstrating substantial equivalence to its predicate device (K200232 LVivo Software Application) based on technological characteristics and intended use. The performance evaluation is broadly stated as confirming conformity to intended use via "well-established test methods," rather than providing detailed quantitative results against specific acceptance criteria. A standalone performance was evaluated for the automated steps of clip selection and EF calculation. Details regarding sample sizes, data provenance, expert involvement, ground truth establishment methods, or MRMC studies are not provided in this specific FDA clearance document.

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