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Cardio Vue Quantitative Analysis TM is an integrated software component of the CardioVue (K060840) medical image management device that analyzes DICOMcompliant cardiovascular images acquired from MRI scanners and produces reports. CardioVue Quantitative Analysis™ assists qualified cardiologist, radiologist or other licensed professional healthcare practitioners in making their diagnosis by performing functional and blood flow analysis and in reporting their patient study findings. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.

CVQ is an add-on module to the proprietary software included in the CardioVue™ workstation (K060840.) CVQ provides clinical quantitative data by analyzing multi-slice, multi-phase DICOM compatible cardiovascular MR images. Functional and blood flow analysis is performed using 2D, 3D and 4D data sets using standard algorithms and user input. MR images may be imported from various sources including images stored on a Cardio Vue" workstation, portable media, network storage devices, PACS, and other vendors systems and supports cardiovascular MR images from all of the major MRI scanner vendors. CVQ can be used for the immediate analysis of cardiovascular MR images at the time of the patient study (real-time) or after the study (post processing.)

The CardioVue Quantitative Analysis TM (CVQ) device is an add-on module for analyzing multi-slice, multi-phase DICOM compatible cardiovascular MR images. The information regarding acceptance criteria and a study proving the device meets these criteria is limited in the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., accuracy, precision) or provide a table summarizing these criteria versus reported device performance.

Instead, the document focuses on establishing substantial equivalence to predicate devices (MRI-Mass and MRI-Flow from Medis Medical Imaging Systems BV) and asserting safety and effectiveness based on that comparison and the device's nature as an image analysis tool that does not alter images.

The closest statements to device performance are:

• "CVQ performs in accordance with its intended use as well as the Medis MRI-Mass and MRI-Flow cardiovascular MRI image analysis products currently on the market."
• "The current versions of these industry standard products used for the operation CVQ are of greater effectiveness and any safety concerns caused by failure of the off-the-shelf components and the CVO software component are no greater than the predicate device."

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

The document does not provide information on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a study directly proving the device's performance against acceptance criteria.

The submission states: "Extensive testing of the software package will be performed by programmers, by non-programmers, quality assurance staff and by potential customers prior to commercial release. (see test plan in Section 6.)" However, the details of this testing (including sample sizes or specifics of "potential customers" datasets) are not provided in the extracted text.

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

Since no specific performance study with a test set is detailed, there is no information provided on the number or qualifications of experts used to establish ground truth.

4. Adjudication Method for the Test Set:

Given the lack of a detailed performance study with a test set, there is no information provided on any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The device is described as a "support tool" for qualified professionals, implying human-in-the-loop use, but no study on its comparative effectiveness in aiding readers is presented.

6. Standalone (Algorithm Only) Performance Study:

The provided information does not indicate that a standalone (algorithm only) performance study was conducted. The device is intended to be used by "a qualified cardiologist or other licensed professional healthcare practitioners to assist them in making their diagnosis," suggesting it's not designed to operate in a fully autonomous, standalone manner.

7. Type of Ground Truth Used:

As no specific performance study is detailed, the type of ground truth used is not mentioned.

8. Sample Size for the Training Set:

The document does not specify any training set sample size. This submission focuses on establishing substantial equivalence to predicate devices rather than detailing the development and training of a machine learning model. While it uses "standard algorithms," it does not describe a process that would typically involve a distinct "training set" in the context of modern AI/ML development.

9. How the Ground Truth for the Training Set Was Established:

Since no training set is mentioned, there is no information on how ground truth for a training set was established.

Summary of Study Information:

The 510(k) submission for CardioVue Quantitative Analysis (CVQ) primarily relies on the concept of substantial equivalence to legally marketed predicate devices (MRI-Mass and MRI-Flow) rather than presenting a detailed, quantitative performance study with specific acceptance criteria, test sets, and reader studies. The core argument is that CVQ performs its intended function "as well as" the predicate devices using "standard algorithms and user inputs" and that it "does not in any way alter the images," thus not raising new questions of safety or effectiveness. The document explicitly states: "On this basis, MRI Cardiac Services, Inc. believes that clinical investigation is not necessary."

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