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Vitrea Software Toshiba Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea has the following additional indications:

The CT/XA Cerebral Artery Morphological Analysis application is intended to facilitate the extraction and segmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.

The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

Vitrea Software Toshiba Package, VSTP-001A, an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images, Inc. Vitrea Software Toshiba Package, VSTP-001A, currently includes three post processing applications, CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, and MR Coronary Tracking which use brain and cardiac image data, obtained from CT/XA/MR systems, to assist physicians in performing specialized measurements and analysis.

The provided document describes the Vitrea Software Toshiba Package, VSTP-001A, which includes several applications. The information regarding acceptance criteria and studies is provided for the new applications being submitted: SUREVolume Synthesis, US Cardiac Fusion, and Angio Viewer.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• SUREVolume Synthesis & US Cardiac Fusion:
  • Sample size: Not explicitly stated as a number of cases or images. The text mentions "various combinations of data sets" for SUREVolume Synthesis and "CCTA images and 3D Wall motion tracking images" for US Cardiac Fusion.
  • Data provenance: Not explicitly stated (e.g., country of origin). The studies were described as "clinical evaluations conducted at clinical sites" for both. The text does not specify retrospective or prospective.
• Angio Viewer:
  • Sample size: Not explicitly stated. The text mentions "repeated measurements."
  • Data provenance: Not explicitly stated. The evaluation was "conducted head on against the predicate device at the design site." Implies retrospective use of existing data for comparison.
• CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking:
  • Sample size: Not explicitly stated. The text mentions "numerical phantoms."
  • Data provenance: Not explicitly stated. These were "bench studies."

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

• SUREVolume Synthesis & US Cardiac Fusion: The text states, "In both studies users of varying levels of experience reviewed all images and performed manual alignments as required." It does not specify the exact number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience").
• Angio Viewer, CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking: Not specified for these applications.

4. Adjudication method for the test set

• SUREVolume Synthesis & US Cardiac Fusion: For these clinical evaluations, "users of varying levels of experience" performed manual alignments when automatic alignment was not successful. This implies that the initial "ground truth" for success/failure of automatic alignment might have been based on their interpretation, and their subsequent manual alignments formed a manual "ground truth" for comparison. An explicit adjudication method like 2+1 or 3+1 is not mentioned.
• Angio Viewer: The evaluation involved "repeated measurements" against a predicate device. This suggests a direct comparison rather than an adjudication process by multiple experts.
• CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking: These involved bench studies with numerical phantoms. Adjudication by experts is not applicable here.

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 reader improvement with or without AI (or in this case, the software applications), is described in the provided text. The studies primarily focused on the performance of the software applications themselves, or direct comparison against a predicate device, rather than a reader study.

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

• SUREVolume Synthesis & US Cardiac Fusion: The studies mention "automatic alignment success" which represents a standalone algorithm performance metric. However, it also clarifies that "users of varying levels of experience" performed manual alignments when automatic alignment failed, indicating that human-in-the-loop performance (manual adjustment) was also evaluated as a fallback.
• Angio Viewer: The "bench testing at the design site against its predicate device" and replicating measurements implies a standalone comparison of the software's measurement capabilities.
• CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking: Bench studies using "numerical phantoms to analyze the accuracy of extraction/display... as well as measurement calculations" clearly represent standalone algorithm performance.

7. The type of ground truth used

• SUREVolume Synthesis & US Cardiac Fusion: The ground truth for fusion success and alignment appears to be based on the assessment of "users of varying levels of experience" at clinical sites. This would fall under an expert consensus/assessment type of ground truth, though the number of experts and their specific consensus method are not detailed.
• Angio Viewer: The ground truth for measurement accuracy was the "predicate device" (Infinix Celeve-I: INFX-8000F) based on measurements obtained from it.
• CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking: The ground truth for these bench studies was "numerical phantoms" and "measurement calculations," implying a precisely defined, known truth.

8. The sample size for the training set

The provided document does not mention the sample size used for the training set for any of the applications. It focuses on the validation/verification studies.

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

The provided document does not mention how the ground truth for the training set was established, as it does not discuss the training process.

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Vitrea Software Toshiba Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea has the following additional indications:

The CT/XA Cerebral Artery Morphological Analysis application is intended to facilitate the extraction and segmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.

The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.

Vitrea Software Toshiba Package, VSTP-001A, an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images, Inc. Vitrea Software Toshiba Package, VSTP-001A, includes three post processing applications, CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, and MR Coronary Tracking which use brain and cardiac image data, obtained from CT/XA/MR systems, to assist physicians in performing specialized measurements and analysis.

The provided text describes the Vitrea Software Toshiba Package, VSTP-001A, and its applications. The most relevant section for acceptance criteria and study details is Section 17, "TESTING," as well as the comparison table in Section 15. The device is a post-processing application, and the most detailed testing information pertains to the "MR Coronary Tracking" application, as the other two applications (CT/XA Cerebral Artery Morphological Analysis and MR Wall Motion Tracking) "remain unchanged" from previously cleared devices (K151093). Therefore, the information below focuses on the MR Coronary Tracking application.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. However, it indicates that "bench studies were conducted using numerical phantoms to analyze the accuracy of extraction/display of the coronary arteries as well as measurement calculations for lumen dimensions and areas." It also states that "clinical evaluations were conducted to demonstrate that the MR Coronary Tracking application performed as intended. The results confirmed that the MR Coronary Tracking application was comparable to commercially released software and user measurements."

Based on these statements, the implicit acceptance criteria are:

• Accuracy of extraction/display of coronary arteries
• Accuracy of measurement calculations for lumen dimensions and areas
• Performance comparable to commercially released software
• Performance comparable to user measurements

Given the provided text, a table of explicit acceptance criteria and specific reported device performance cannot be fully constructed with quantitative values. The document states that the "requirements for the MR Coronary Tracking application has been met" and that the results "confirmed that the MR Coronary Tracking application was comparable to commercially released software and user measurements." This implies successful meeting of the criteria.

Study Details

1. A table of acceptance criteria and the reported device performance
   As explained above, explicit quantitative acceptance criteria and performance data are not provided in the text. The document broadly states that the requirements were met and the performance was comparable.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
   The document mentions both "numerical phantoms" for bench studies and "clinical evaluations" for the MR Coronary Tracking application.

   • Numerical Phantoms: Used for bench studies to analyze accuracy of extraction/display and measurement calculations. The sample size for these phantoms is not specified.
   • Clinical Evaluations: Performed to demonstrate the application "performed as intended." The sample size for the clinical evaluations is not specified.
   • Data Provenance: The document does not specify the country of origin of the data or whether the clinical evaluations were retrospective or prospective.

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)
   The document states that the results "confirmed that the MR Coronary Tracking application was comparable to... user measurements." This implies human experts were involved, likely for "user measurements" which served as a comparator. However, the number of experts and their specific qualifications are not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
   The document does not specify any adjudication method 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 describe a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance, nor does it provide an effect size. The study described focuses on the standalone performance and comparability of the software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Yes, a form of standalone performance evaluation was done. The document states: "Bench studies were conducted using numerical phantoms to analyze the accuracy of extraction/display of the coronary arteries as well as measurement calculations for lumen dimensions and areas." This implies direct evaluation of the algorithm's output against a known ground truth (the phantom).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   For the "bench studies," the ground truth was derived from numerical phantoms. For the "clinical evaluations," the ground truth for comparison appears to be "commercially released software and user measurements," which implies human expert measurements or another established software's output served as a comparator for the clinical performance, rather than a definitive "ground truth" such as pathology.

8. The sample size for the training set
   The document does not specify the sample size for the training set. It only describes testing for the MR Coronary Tracking application.

9. 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.

Ask a specific question about this device

Vitrea Software Toshiba Package is an application package developed for use on Vitrea, a medical image processing software, which includes the following post-processing software applications.

CT/XA Cerebral Artery Morphological Analysis This software is intended to facilitate the extraction and seqmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

MR Wall Motion Tracking This application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and reqional myocardial function that is used for patients with suspected heart disease.

Vitrea Software Toshiba Package, VSTP-001A, an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images. Inc. Vitrea Software Toshiba Package, VSTP-001A, includes two post processing applications, CT/XA Cerebral Artery Morphological Analysis and MR Wall Motion Tracking, which use brain and cardiac image data, obtained from CT/XA/MR systems, to assist physicians in performing specialized measurements and analysis.

Here's a breakdown of the acceptance criteria and study information for the Vitrea Software Toshiba Package, VSTP-001A, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device includes two main applications: CT/XA Cerebral Artery Morphological Analysis and MR Wall Motion Tracking. The document describes the performance of a test but doesn't explicitly list "acceptance criteria" as a defined threshold value for each metric. Instead, it states that the studies demonstrated the device performed as intended and met required success ratios compared to manual methods or prior versions.

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

• CT/XA Cerebral Artery Morphological Analysis: The document mentions "clinical evaluations" and "bench studies using numerical phantoms." It does not specify the sample size for either the clinical evaluations or the numerical phantom studies.
• MR Wall Motion Tracking: Similar to the CT/XA application, "clinical evaluations" and "bench studies using numerical phantoms" were conducted. The sample size is not specified for either.
• Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It only mentions "clinical evaluations."

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

The document does not specify the number of experts used or their specific qualifications for establishing ground truth for the test set. It mentions "manual measurements and/or segmentations" for the CT/XA application, implying expert human input, but details are absent.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1) for the test set.

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

No, the document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the device's performance compared to manual methods or prior versions, but not on how human readers improve with AI versus without AI assistance.

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

Yes, standalone (algorithm only) performance seems to have been evaluated. The benchmarking using "numerical phantoms" and assessment of "accuracy of extraction/display" and "measurement calculations" for the CT/XA application, and "cardiac function and strain" for the MR application, suggests standalone testing. The statement about "contour tracking process... met the required success ratio" for MR Wall Motion Tracking also implies standalone algorithm evaluation.

7. The Type of Ground Truth Used

• CT/XA Cerebral Artery Morphological Analysis: The ground truth appears to be based on expert human measurements and/or segmentations ("comparable to manual measurements and/or segmentations") and numerical phantoms for accuracy.
• MR Wall Motion Tracking: The ground truth also seems to be based on numerical phantoms for accuracy analysis of cardiac function and strain, and an "intended" or "required success ratio" for contour tracking, which would likely be established against a reference standard or expert review.

8. The Sample Size for the Training Set

The document does not mention the sample size for the training set for either application. It focuses on verification/validation testing.

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 it does not discuss the training process or dataset.

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