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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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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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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.

Ask a specific question about this device

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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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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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

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