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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 Cerebral Aneurysm 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.

The Ultrasound Clinical Applications are indicated for the visualization of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

Vitrea Software 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 seven post processing applications, CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking and Ultrasound Applications Package, 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 a 510(k) submission for the Vitrea Software Package, VSTP-001A. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond general statements about equivalence to a predicate device through "bench testing" and "regression testing".

The document states:

• "Risk analysis and regression testing was conducted through bench testing are included in this submission which demonstrates that the requirements for the applications have been met."
• "Bench studies were conducted using sample data sets from the predicate device verification activities (K173090) and verifying that the outputs for both devices were substantially the same."
• "Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate device."

This indicates that the primary method of demonstrating performance was through comparative bench testing against a predicate device, focusing on "substantially the same" outputs. It does not provide the quantitative details typically associated with acceptance criteria tables and clinical/algorithm performance studies as outlined in your request.

Therefore, I cannot populate the requested tables and specific study details.

Here's why and what's missing, based on your request:
1. A table of acceptance criteria and the reported device performance:
* Not Available: The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, measurement accuracy thresholds) or corresponding reported performance metrics for any specific application within the Vitrea Software Package. It only mentions that "requirements...have been met" through bench testing.

2. Sample size used for the test set and the data provenance:
* Not Available: The document mentions "sample data sets from the predicate device verification activities (K173090)" were used for bench testing. It does not specify the sample size, country of origin, or if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not Applicable/Not Available: The testing described is "bench testing" comparing outputs to a predicate device. This implies a technical verification of outputs rather than an expert-driven "ground truth" establishment for diagnostic accuracy, as would be the case for an AI-driven diagnostic aid. No experts are mentioned in the context of ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not Applicable/Not Available: Adjudication methods are typically used when multiple human readers interpret data to establish a consensus ground truth. This type of study is not described.

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: The document does not describe an MRMC study. The device is a "post-processing application" to "assist physicians in performing specialized measurements and analysis," but no study on human performance improvement with or without the device is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes (partially, but no detailed metrics): The "bench testing" implicitly acts as a "standalone" performance check in that it verifies the software's outputs against known outputs from the predicate device. However, no specific standalone performance metrics (like accuracy for a classification task) are provided, only that the outputs were "substantially the same."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not explicitly stated/Implied "Predicate Device Outputs": The "ground truth" for the bench testing appears to be the outputs generated by the predicate device (K173090). This is a technical comparison rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set:
* Not Applicable/Not Available: This device is described as software for "post-processing" and "analysis" that applies "formulas, algorithms and measurements" similar to a predicate. There is no mention of machine learning or deep learning, and therefore no "training set" in the sense of an ML model.

9. How the ground truth for the training set was established:
* Not Applicable/Not Available: As no training set for an ML model is mentioned, this question is not applicable.

In conclusion, the 510(k) summary focuses on demonstrating substantial equivalence primarily through technical bench testing against a predicate device, and it does not provide the detailed performance study results that would typically be associated with AI-driven devices requiring specific quantitative acceptance criteria and clinical validation studies.

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