(98 days)
Vitrea Software 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 Cerebral Aneurysm Analysis application is intended to facilitate the extraction 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.
The Ultrasound Clinical Applications are indication of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.
The Spectral Stone Analysis application is intended to serve as an adjunct visualization tool for the differentiation between uric acid and non-uric acid stones greater than 3 mm with Spectral CT studies acquired on the Canon Medical Systems scanner.
The Spectral Composition Analysis application is intended to assist a physician in visualizing the presence of monosodium urate in anatomical structures. The clinical syndrome of gout is characterized by the presence of monosodium urate crystals in joints or soft tissue.
The Embolization Plan application is a post processing software that is intended to assist physicians in the visualization of the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT acquired by Toshiba or Canon Medical Systems. It provides tools to assist the user in analysis of these images. The output is intended to be an adjunct means that allows automatic and manual planning of the liver arterial vessels for guidance of the embolization procedure. The output is a 3D visualization of the hepatic arteries to high dense lesion in the liver.
The Spectral Analysis application is a CT, non-invasive image analysis software package, which may be used to aid in the visualization of anatomical and pathological materials. The software provides quantification of Hounsfield units of iodine attenuation differences and iodine concentration and display by color.
Effective Z and Electron Density maps may aid in the differentiation of different tissues in the human body.
Vitrea Software Package, VSTP-001A, is an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images, Inc. Vitrea Software Package, VSTP-001A, currently includes ten post processing applications, MR Wall Motion Tracking, Cerebral Aneurysm Analysis, MR Coronary Tracking, SUREVolume Synthesis, Angio Viewer, US Cardiac Fusion, Ultrasound Applications Package, Dual Energy Stone Analysis, Dual Energy Composition Analysis and Embolization Planning Tool which use brain, body or cardiac image data, obtained from CT/XA/MR/US systems, to assist physicians in performing specialized measurements and analysis.
The provided text describes the Vitrea Software Package, VSTP-001A, and its predicate device. This submission focuses on modifications to three specific applications: Spectral Stone Analysis, Spectral Composition Analysis, and Spectral Analysis. The provided text does not contain detailed information about specific acceptance criteria and the comprehensive study results to prove the device meets these criteria in the format requested.
The document is a 510(k) summary, which typically provides a high-level overview of substantial equivalence, and not the full study report with detailed performance metrics.
However, based on the available information, I can infer some aspects and highlight what is missing:
Missing Information:
The document lacks the explicit details for most of your requested points, including:
- A clear table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding reported performance for the modified spectral analysis features.
- Detailed sample sizes used for the test set (number of patients/cases, number of images).
- Data provenance beyond the mention of "clinical images" and "phantom studies."
- Specific number of experts, their qualifications, and adjudication methods for ground truth.
- Whether an MRMC comparative effectiveness study was done or its effect size.
- Specific details of standalone algorithm performance.
- The exact type of ground truth used (e.g., only expert consensus vs. pathology validation).
- Sample size for the training set and how its ground truth was established.
Based on the available text, here's a breakdown of what can be extracted and what remains unknown regarding acceptance criteria and the study:
The submission focuses on modifications to existing features and argues substantial equivalence to a previously cleared device (K192923). The "Testing" section mentions the types of studies conducted but does not provide specific performance results or acceptance criteria in a quantifiable manner.
Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not Explicitly Stated | The document states "Results of all these studies demonstrate that the features included in this submission meet specifications and perform as intended." However, no specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, recall, AUC) or quantitative acceptance thresholds are provided for any of the modified spectral analysis applications. It implies that the modifications did not degrade the performance previously established for the predicate device. |
Study Details (Inferred and Missing)
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "clinical images" and "phantom studies" were used, but the number of cases, scans, or images for either is not provided.
- Data Provenance: Not explicitly stated. The document mentions "clinical images," implying real patient data, and "phantom studies." No information about the country of origin, or whether the data was retrospective or prospective, is given.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated. The document mentions "A physician review of clinical images was also performed," but the number of physicians is not specified.
- Qualifications of Experts: Not explicitly stated. The document only refers to "physician," without specifying their specialty (e.g., radiologist, urologist) or years of experience.
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Adjudication method for the test set:
- Adjudication Method: Not explicitly stated. It's unknown if multiple readers independently assessed cases and, if so, how disagreements were resolved (e.g., 2+1, 3+1, or simple majority).
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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: Not explicitly stated. The primary focus of the submission appears to be on maintaining substantial equivalence of modified features, rather than demonstrating human-AI augmentation. The "physician review" mentioned seems to be for validation of the device outputs rather than a comparative study of human performance with and without the device. The device is described as "adjunct."
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not explicitly stated quantitatively. The emphasis is on the software as an "adjunct visualization tool" to assist physicians. While the software has its own "analysis result display" and "image processing," explicit standalone performance metrics (e.g., for segmentation accuracy or classification) are not provided. The statement "meet specifications and perform as intended" refers to the overall system's function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Inferred to be Expert Consensus for clinical images, and known values for phantom studies. The "physician review of clinical images" suggests expert consensus was a component of ground truth determination for clinical data. For "phantom studies," the ground truth would be precisely known physical properties.
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The sample size for the training set:
- Training Set Sample Size: Not mentioned. Standard in 510(k) summary documents, information on training set size and specific details of model development are typically proprietary and not included in this high-level summary.
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How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not mentioned. As with the training set size, this detail is typically not found in a 510(k) summary.
Summary of what's provided related to "acceptance criteria" and "study":
The document states that "Risk analysis and verification/validation activities conducted through bench testing" and "Additional performance testing, using phantom studies" were performed. It also mentions "A physician review of clinical images" to support a new promotional claim. The overarching conclusion is that "Results of all these studies demonstrate that the features included in this submission meet specifications and perform as intended."
However, the specific quantitative "acceptance criteria" (e.g., a sensitivity threshold of X% or a mean absolute error less than Y) and the detailed results showing how these criteria were met are absent from this 510(k) summary. The document asserts that the modifications to the three spectral analysis applications were evaluated, risks were reduced, and the device performs as intended and is substantially equivalent to its predicate. This assertion implies that internal acceptance criteria were met, but those criteria themselves are not disclosed.
§ 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).