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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. 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.

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. 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 details for the LVivo Software Application, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

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

   • EF Analysis: 96 examinations from a dataset of 100 ambulatory and hospitalized patients.
   • SWM and GLS Analysis: 98 examinations from the same dataset of 100 ambulatory and hospitalized patients.
   • Data Provenance: Retrospective, collected according to GCP standards from ambulatory and hospitalized patients referred for routine transthoracic echocardiography. The country of origin is not explicitly stated.

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

   • This information is not provided in the given text. The text mentions "reference WSMI" and comparisons to a "subject device" (likely the predicate device's performance benchmarks), but it does not detail how the initial ground truth for the reference measurements was established.

3. Adjudication method for the test set:

   • This information is not explicitly provided. The text refers to "reference" values but does not describe the adjudication process (e.g., expert consensus) if multiple readers were involved in establishing these reference values.

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 MRMC comparative effectiveness study involving human readers with and without AI assistance was not described in this summary. The study focuses on evaluating the standalone performance of the AI algorithm against established reference values or the predicate device's performance.

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 performed. The acceptance criteria and "reported device performance" (implicitly met) directly relate to the algorithm's performance on the test set.

6. The type of ground truth used:

   • The ground truth appears to be based on clinically established methods and possibly expert consensus/measurements, as implied by "reference" values and comparison to "reference WSMI." The summary states the data was collected for "routine transthoracic echocardiography," suggesting standard clinical measurements were used as a basis. However, the specific method of establishing this ground truth (e.g., expert manual measurements, pathology) is not explicitly detailed.

7. The sample size for the training set:

   • The sample size for the training set is not provided in the given text. The document describes the test set but offers no details on the data used to train the "neural network" cited as a modification.

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

   • This information is not provided in the given text.

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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.

The LVivo 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. It also has the ability to measure strain and to evaluate the Right Ventricle and well as to measure the bladder.

This document describes the acceptance criteria and study results for DiA Imaging Analysis Ltd's LVivo Software Application, specifically focusing on its LVivoRV (Right Ventricular) and LVivo Bladder modules.

1. Table of Acceptance Criteria and Reported Device Performance

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

• LVivoRV: The exact sample size for the test set is not explicitly stated. The study mentions that examinations were collected over a period of 22 months retrospectively. It includes RV clips from 4CH and 4CH modified views that had 2-3 stable recorded beats.

  • Data Provenance: Retrospective, single-center study. The data was retrieved from PACS systems available on-site at the study center.

• LVivo Bladder: 226 bladder images (113 pairs of transverse and longitudinal views) were included.

  • Data Provenance: Retrospective, single-center study. Examinations were retrieved from PACS systems available in Terem's clinic. The data was collected as part of routine abdominal examinations.

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

• LVivoRV:

  • FAC, EDA, ESA: Ground truth was established by two sonographers who manually traced the ED and ES frames. Their qualifications are not explicitly detailed beyond being "sonographers."
  • TAPSE: Ground truth was established by a sonographer (using M-Mode) and an echo cardiologist (using VVI).
  • S': Ground truth was established by a sonographer (using M-Mode) and an echo cardiologist (using VVI).
  • RV Strain: Ground truth was established by an echo cardiologist (using VVI).
  • Overall Qualification Level: Sonographers and echo cardiologists are qualified medical professionals routinely performing these measurements.

• LVivo Bladder:

  • Ground truth was established by one expert sonographer who performed manual measurements of bladder volume (D1, D2, D3) from the trans and long views. The manual measurements were considered the reference/ground truth.

4. Adjudication Method for the Test Set

• LVivoRV:

  • For EDA, ESA, and FAC, the LVivoRV's automated values were compared to the average of the values obtained manually by the two sonographers. This implies a form of consensus or averaging method.
  • For TAPSE and S', measurements from a sonographer (M-Mode) and an echo cardiologist (VVI) were used for comparison, but it's not explicitly stated if there was an adjudication for a single ground truth value when both measurements were available. However, the report compares LVivoRV to "manual measurement using M-Mode" and also notes correlation between VVI and M-Mode, suggesting separate comparisons rather than a combined adjudication.

• LVivo Bladder:

  • The manual measurements performed by the single expert sonographer served as the ground truth. There was no explicit adjudication among multiple experts since only one expert provided the manual measurements for the validation.

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

• No MRMC comparative effectiveness study, evaluating human readers with and without AI assistance, was reported in this document. The studies were focused on the standalone performance of the LVivoRV and LVivo Bladder modules against manual measurements or established methods.

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

• Yes, standalone performance studies were done for both LVivoRV and LVivo Bladder.
  • LVivoRV: The algorithm's output was generated "by an automated batch processing after all data was ready and considered locked." This indicates the algorithm processed the data without human intervention to influence its initial measurements. Manual adjustments are available in the device, but the reported study focuses on the automated output.
  • LVivo Bladder: The algorithm was applied "by an automated batch processing on all pairs of trans and long views," also indicating standalone performance for the reported results. The device allows for manual caliper adjustments, but the validation appears to have used the automated result.

7. The Type of Ground Truth Used

• LVivoRV: Expert consensus/manual measurements from qualified medical professionals (sonographers and echo cardiologists) based on conventional echocardiography methods (2D manual measurements, M-Mode, VVI).
• LVivo Bladder: Expert manual measurements by an expert sonographer, considered the routinely used method for bladder volume measurement.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size used for the training set for either LVivoRV or LVivo Bladder. It only describes the algorithms and their application to the test sets.

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

• The document does not provide details on how the ground truth for the training set was established. It describes the technology for LVivoRV as combining "image processing and Deep Learning Neural Network (NN)" and for LVivo Bladder as using "a combination of machine learning and active contour," implying the use of training data, but no specifics are given regarding its ground truth establishment.

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DiaCardio's LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular function evaluation. This measurement can be used to assist the clinician in a cardiac evaluation.

The LVivo 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. It also has the ability to measure strain

Here's a breakdown of the acceptance criteria and study information for the LVivo Software Application, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on the performance of the LVivoSG module and its correlation with established methods rather than explicit "acceptance criteria" presented as pass/fail thresholds. However, we can infer the desired performance from the study objectives and results.

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

• Test Set Sample Size: 100 subjects (ultrasound clips of 100 subjects).
• Data Provenance: Retrospective, single-center study. Ultrasound examinations were collected prospectively according to protocol 100 rev 03 at "Soroka university medical center" (in Israel, based on the manufacturer's address).

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

• Number of Experts: At least two distinct groups of experts:
  • "Physicians of the echo department in Soroka university medical center" who routinely evaluated segmental wall motion qualitatively.
  • An "Additional investigator (expert echocardiologist)" who performed segmental strain evaluation using Syngo® Velocity Vector Imaging (VVI) SW (Siemens) blindly.
  • The "PI" (Principal Investigator) who evaluated examinations with impaired global LV function that lacked routine segmental WM scores.
• Qualifications of Experts:
  • "Physicians of the echo department" (implied to be qualified in echocardiography).
  • "Expert echocardiologist."
  • "PI" (implied to be an expert in echocardiography, given their role in evaluating complex cases).

4. Adjudication Method for the Test Set

The document describes several comparisons:

• LVivoSG WM evaluation was compared against "visual estimation" by physicians. This implies the physicians' visual estimation served as a form of ground truth or benchmark, rather than a formal adjudication of LVivoSG's output.
• LVivoSG longitudinal strain was compared against VVI, applied by an "additional investigator (expert echocardiologist)" blindly. This suggests the VVI measurements by this expert served as a reference.

There is no explicit mention of an adjudication method like 2+1 or 3+1 to establish a consensus ground truth amongst multiple experts for the test set itself. Instead, the study compares the device's performance against pre-existing routine evaluations (for WM) and expert-performed measurements using a predicate device (for strain).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?

No, a MRMC comparative effectiveness study where human readers improve with AI assistance vs. without AI assistance was not done.

The study's primary goal was to compare the performance of the LVivoSG system itself against established methods (manual methods, visual estimation, and a predicate device like VVI), not to evaluate the improvement of human readers using the AI. The device is described as a "decision support tool," implying assistance, but the study design doesn't measure this specific human-in-the-loop improvement.

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

Yes, a standalone performance study was done. The results reported (correlation coefficients, ICC, kappa, sensitivity, specificity, AUC) directly reflect the performance of the LVivoSG algorithms in automatically evaluating segmental wall motion and strain. The comparisons are between the LVivoSG's output and the ground truth/reference methods, without an intermediate human interaction being measured.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth was a combination of:

• Expert Visual Estimation: For segmental wall motion evaluation, the "routinely evaluated for segmental wall motion evaluation qualitatively by the physicians of the echo department."
• Expert-Applied Predicate Device Measurement: For segmental longitudinal strain, the ground truth was established by an "expert echocardiologist" using the Syngo® Velocity Vector Imaging (VVI) SW (Siemens), a recognized predicate technology.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It only mentions the "100 subjects" used for the clinical trial (test set) for the LVivoSG.

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

Since the training set size and characteristics are not provided, how the ground truth for the training set was established is also not described in this document.

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