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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. In addition, it has the ability to provide Quality Score feedback.

The LVivo platform is a software system for automated analysis of ultrasound examinations. Automated analysis of echocardiographic examinations is done using DICOM movies. The LVivo platform supports global and segmental evaluation of the left ventricle (LV) of the heart utilizing the apical views. Global LV function evaluation by ejection fraction (EF) is done based on two of the apical views: four-chamber (4CH) and two-chamber (2CH). Segmental LV function evaluation is done from three apical views 4CH, 2CH and three chamber (3CH) and supports segmental wall motion evaluation and strain. The LVivo platform supports also LV function evaluation from the parasternal views including global and segmental LV function analysis from the Short Axis (SAX) view and the global LV function analysis form the Parasternal Long Axis (PLAX) views.

In addition to the LV analysis, the cardiology toolbox includes a module for automated evaluation of the Right Ventricular function. The LVivo platform includes one additional non-cardiac module for the measurement of the bladder volume.

The LVivo Platform includes also two additional configurations: LVivo Seamless for offline analysis based on automatically selected views and LVivo IQS for real-time quality feedback during image acquisition

Here's an analysis of the provided text to fulfill your request, broken down by the specified information points:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the performance metrics (Specificity, Sensitivity, Accuracy, Correlation) in a pass/fail format prior to presenting the results. Instead, it presents the achieved performance. However, we can infer that the reported values are what the manufacturer considers acceptable for equivalence.

Inferred Acceptance Criteria (Based on Study Results):

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Main Test Set:
  • Sample Size: 170 echo exams.
  • Data Provenance:
    • 101 exams from a medical center in the US.
    • 69 exams from two medical centers in Israel.
  • Nature of Data: Retrospective (implied by the description "The exams were collected..." and subsequent analysis; not explicitly stated as prospective).
• Second Validation Set:
  • Sample Size: 101 patients.
  • Data Provenance: From a hospital in Taiwan.
  • Nature of Data: Retrospective (implied).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Three cardiologists.
• Qualifications of Experts: Specializing in echo. (No further details on specific experience or certifications are provided).

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

• Adjudication Method: "WMSI average across three cardiologists specializing in echo." This indicates a consensus approach where the average of the three experts' interpretations formed the ground truth (e.g., if one expert was an outlier, their reading would still contribute to the average).

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not conducted or reported.
• The study focuses on the standalone performance of the AI algorithm compared to expert-defined ground truth. It also shows the inter-expert variability (ICC between experts).

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

• Standalone Performance: Yes, the reported performance metrics (Specificity, Sensitivity, Accuracy, Pearson Correlation, ICC) are for the standalone algorithm's performance against the established ground truth, without human intervention or assistance during the assessment.

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

• Type of Ground Truth: Expert consensus. Specifically, "WMSI average across three cardiologists specializing in echo."

8. The sample size for the training set

• Training Set Sample Size: The document does not provide the sample size for the training set. It only describes the validation sets.

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

• Training Set Ground Truth: The document does not provide information on how the ground truth for the training set was established. It only details the ground truth establishment for the test/validation sets.

This analysis is based solely on the provided text. Any information not explicitly stated in the document cannot be inferred.

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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. In addition, it has the ability to provide Quality Score feedback.

The LVivo platform is a software system for automated analysis of ultrasound examinations. Automated analysis of echocardiographic examinations is done using DICOM movies. The LVivo platform supports global and segmental evaluation of the left ventricle (LV) of the heart. The global LV function is evaluated from two of the apical views: four-chamber (4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LV function is done from three apical views 4CH, 2CH and three chamber (3CH) and supports wall motion evaluation and strain. LVivo CE-EF (Contrast EF) extends the current toolbox of the LVivo platform by providing the ability to process Ultrasonic DICOM images which acquire by Ultrasound Equipment in which the patient was prescribed a contrast agent. In addition to the LV analysis, the cardiology toolbox includes a module for automated evaluation of the Right Ventricular function. The LVivo platform includes one additional non-cardiac module for the measurement of the bladder volume.

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

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Sample Size: 101 patient exams.
   • Data Provenance: The data was collected from multiple sources: Beth Israel, Soroka, Hadassah (presumably Israel, based on the manufacturer's location), and UCMC (likely a US center given the race information collection). The text indicates that 69 of the 101 patients were collected from the US. The study is retrospective, as it refers to collected "patient exams."

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

   • Number of Experts: 3 sonographers.
   • Qualifications: The text explicitly states "3 sonographers" were used. While their specific years of experience are not mentioned, the implication is that they are qualified medical professionals capable of performing and interpreting ultrasound measurements. The subsequent review by a cardiologist also suggests oversight and validation of their measurements.

3. Adjudication method for the test set:

   • The ground truth was "comprised of the measurements by the 3 sonographers." This suggests a consensus or averaging approach among the three sonographers. It further states, "No further changes by the cardiologist to the measurements were needed following the cardiologist's review," implying the cardiologist reviewed and implicitly approved the sonographers' consensus measurements. This could be interpreted as a form of expert consensus adjudication, where the sonographers' measurements formed the basis, and a cardiologist provided final validation.

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 comparing human readers with and without AI assistance was not described. This study directly compared the algorithm's performance to human (sonographer) ground truth measurements rather than assessing human reader improvement with AI assistance.

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

   • Yes, a standalone performance evaluation of the algorithm was done. The study compares the "automated results" of the LVivo Software Application to the established "manual measurements" (ground truth). The fact that the algorithm "processed automatically 91/101 (90%) of the exams" and these automated results were compared to the manually derived ground truth confirms a standalone evaluation.

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

   • The ground truth used was expert consensus based on "manual measurements" performed by "3 sonographers," which were then reviewed and confirmed by a cardiologist.

7. The sample size for the training set:

   • The document does not provide the sample size for the training set. It only discusses the performance evaluation using the test set of 101 patient exams.

8. How the ground truth for the training set was established:

   • The document does not provide any information on how the ground truth for the training set was established. The focus of this submission is on the performance evaluation of the final device using a designated test set.

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L Vivo 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 LVivo platform is a software system for automated analysis of ultrasound examinations. Automated analysis of echocardiographic examinations is done using DICOM movies. The LVivo platform supports global and segmental evaluation of the left ventricle (LV) of the heart. The global LV function is evaluated from two of the apical views: four-chamber (4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LV function is done from three apical views 4CH, 2CH and three chamber (3CH) and supports wall motion evaluation and strain. The LVivo platform supports also global and segmental evaluation of the LV from the parasternal Short Axis (SAX) view and the Parasternal Long Axis view (PLAX).

LVivo PLAX extends the current toolbox of the LVivo platform, providing automated calculation of LV size and function parameters from the PLAX view, for cardiac function evaluation as part of the standard echocardiographic assessment in Echo environment and point-of-care. The measurements from the PLAX view add information about the contraction of the LV, its size and wall thickness and can be used for rapid evaluation of the patient's condition in the point-of-care.

In addition to the LV analysis, the cardiology toolbox includes a module for automated evaluation of the Right Ventricular function and the LVivo Seamless. The LVivo platform includes one additional non-cardiac module for the measurement of the bladder volume.

Here's an analysis of the acceptance criteria and study as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for parameters other than FS are not explicitly stated in the provided text, but the results for correlation, bias, and LOA are reported, implying these were considered for acceptance. The FS correlation of 0.74 for the additional dataset is slightly below the 0.75 acceptance criteria, but the text states "The primary end point was met" and makes an overall conclusion of substantial equivalence, implying this difference was deemed acceptable in context.

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

• Primary Clinical Validation:
  • Sample Size: 121 patients
  • Data Provenance: Not explicitly stated, but mentioned to be "according to GCP standards."
  • Retrospective or Prospective: Not explicitly stated.
• Additional Dataset (for LVivo PLAX validation):
  • Sample Size: 40 patients
  • Data Provenance: USA-based medical center
  • Retrospective or Prospective: Not explicitly stated.

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

• Number of Experts: Two sonographers.
• Qualifications: Not explicitly stated beyond "sonographers."

4. Adjudication Method for the Test Set

• The text states "The correlation vs average manual measurements of two sonographers." This suggests a method of averaging measurements from two experts to establish the ground truth. It is not a 2+1 or 3+1 adjudication method where a third expert breaks ties, but rather a consensus via averaging.

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

• There is no mention of an MRMC comparative effectiveness study done to compare human readers with and without AI assistance. The study focuses on the standalone performance of the AI against human measurements.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The study compares the LVivo Software Application's automated analysis results against manual measurements performed by sonographers. For the primary study, 82% of exams were automatically analyzed, and for the additional dataset, 90% were automatically analyzed, indicating standalone algorithm-only performance.

7. Type of Ground Truth Used

• Expert Consensus (via averaging): The ground truth was established by "average manual measurements of two sonographers."

8. Sample Size for the Training Set

• The document does not provide information regarding the sample size used for the training set. This information is typically proprietary to the manufacturer and not released in 510(k) summaries unless specifically required or relevant for substantial equivalence claims.

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. This is also typically proprietary and not typically included in these types of summary documents.

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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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