Search Results

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."

Ask a specific question about this device

SView 1.0 is a medical image management device intended for viewing, manipulating and analyzing DICOM-compliant medical images acquired from MRI scanners and other DICOM -compliant imaging devices. SView™ 1.0 can be used for real-time image viewing, manipulation and analysis that aid a cardiologist or radiologist in their diagnosis. In addition, it facilitates the physician's reporting and reviewing of patient studies.

SView " 1.0 is a tool for 2D (two-dimensional) viewing and manipulation of DICOM compliant MR images and other DICOM-compliant images. The proposed device provides real-time image viewing, manipulation, analysis and reporting.

The provided 510(k) summary for the SView™ Version 1.0 PACS/Medical Image Management Device does not describe an acceptance criteria or a study proving the device meets said criteria in the way typically associated with algorithms or AI models.

This device is classified as a "PACS / Medical Image Management Device" and a "System, Image Processing." The 510(k) summary explicitly states:

"The SView™ medical image management device contains no image digitizers and uses only lossless compression. On this basis, MRI Cardiac Services, Inc. believes that clinical investigation is not necessary."

Instead of a clinical study, the submission focuses on demonstrating substantial equivalence to a predicate device (AccuView Diagnostic Imaging Workstation Software Package, K990241) by comparing features and specifications. The "Laboratory and Clinical Testing" section describes general software testing rather than a performance study against clinical endpoints or ground truth.

Therefore, many of the requested details about acceptance criteria, performance, sample sizes, and ground truth are not applicable to the information provided in this 510(k) summary.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The submission does not define specific performance metrics or acceptance criteria for an algorithm's diagnostic performance. The substantial equivalence argument rests on functional equivalency with the predicate device for image viewing and manipulation.

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

• Test Set Sample Size: Not applicable. No clinical test set for algorithmic performance evaluation is described.
• Data Provenance: Not applicable.

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

Not applicable. No ground truth establishment for a diagnostic algorithm is described.

4. Adjudication method for the test set:

Not applicable. No test set requiring adjudication is 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 explicitly states that "clinical investigation is not necessary." Therefore, no MRMC study was conducted.

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

Not applicable. This device is described as a "tool for 2D (two-dimensional) viewing and manipulation of DICOM compliant MR images" and not a standalone diagnostic algorithm. Its function is to aid a cardiologist or radiologist, implying a human-in-the-loop scenario, but no performance study is detailed.

7. The type of ground truth used:

Not applicable. No ground truth for an algorithm's diagnostic performance is mentioned.

8. The sample size for the training set:

Not applicable. This device is a PACS/image management system, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, no training set or ground truth for training is described.

Summary of what the document does say about testing:

• Laboratory and Clinical Testing: "SView 1.0 is intended for use with existing MRI images for real-time image viewing, image manipulation, and analysis that aid a cardiologist or radiologist in their diagnosis. In addition it facilitates the physician's reporting and reviewing of patient studies. The SView™ medical image management device contains no image digitizers and uses only lossless compression. On this basis, MRI Cardiac Services, Inc. believes that clinical investigation is not necessary."
• Software Testing: "Extensive testing of the device will be performed by programmers, by nonprogrammers, quality assurance staff and by potential customers prior to commercial release." This refers to software validation and verification, not clinical performance studies.

In conclusion, this 510(k) summary for SView™ 1.0 explicitly states that clinical investigation (and by extension, the detailed performance studies, ground truth establishment, and sample sizes you've asked about) was deemed unnecessary because the device is a medical image management system that does not perform diagnostic algorithms, uses lossless compression, and is claiming substantial equivalence based on functional similarity to an existing predicate device.

Ask a specific question about this device