(43 days)
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
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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. -
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.
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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. -
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. -
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. -
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). -
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. -
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. -
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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).