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510(k) Data Aggregation
(493 days)
QIR Suite
QIR Suite is intended to be used for viewing, post-processing, and quantitative evaluation of cardiovascular Magnetic Resonance (MR) images in a DICOM (Digital Imaging and Communication in Medicine) Standard format. The software has been validated for use on adult patients.
QIR Suite comprises QIR-MR for analysis of MR images. QIR-MR is composed of a viewer and analysis modules, and uses user inputs, standard algorithms, and/or automated deep learning detection algorithms.
QIR Suite support the following functionalities:
· Receive, store, transmit, post-process, display, and manipulate medical MR/CT images in the DICOM format (all transfer syntaxes supported including JPEG2000).
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· Client/server functionalities to connect to a PACS (Picture Archiving and Communication System), to a HL7 server.
· Visualization of 2D and 2D + time of single or multiple MR datasets. -
· Segmentation of regions of interest.
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· Measurement of distances and areas.
· Cardiac function MR analyses for the four chambers, including ejection assessment, local myocardial mass, diastolic function, thickness and thickening.
• 2D Flow studies.
Each module generates an automated report of the analysis. QIR Suite allows connection and storage of analyses on a PACS and on a HL7 server.
The software is not intended for use by patients, but rather by qualified medical professionals, experienced in examining and interpreting cardiovascular MR images to obtain diagnostic information as part of a comprehensive diagnostic decision-making process. OIR Suite cannot replace the diagnosis of a qualified practitioner and cannot be regarded as a sole medical point-of-view. The final diagnosis is the sole responsibility of the practitioner.
QIR Suite is a software for quantitative analyses of cardiovascular magnetic resonance images in the DICOM format. Analyses are performed using standardized and deep-learning algorithms. QIR Suite has been validated for adult patients. QIR Suite is intended to be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR images for the purpose of obtaining diagnostic information, as part of a comprehensive diagnostic decision-making process. QIR Suite cannot replace the diagnosis of a qualified practitioner and cannot be regarded as a sole medical point-of-view.
Acceptance Criteria and Device Performance Study for QIR Suite
1. Table of Acceptance Criteria and Reported Device Performance
The performance testing for QIR Suite focused on demonstrating substantial equivalence to predicate devices (Segment CMR and CVI42) by comparing quantitative measurements and evaluating deep learning algorithm performance. The acceptance criteria and reported device performance are summarized below:
| Feature/Parameter Tested | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Quantitative Parameters (Comparison with Predicate Devices) | ||
| Correlation Coefficient (R²) for all measurements (QIR Suite vs. Predicate) | R² > 0.95 | Systematically above 0.97, with an average correlation above 0.99 for all comparisons. Specifically, for cardiac function parameters, the minimum R² was 0.9792, and most were above 0.99, with an average of 0.9954. For 2D flow parameters, the minimum R² was 0.9590, and most were above 0.99, with an average of 0.9907. |
| Absolute Mean Difference for all measurements (QIR Suite vs. Predicate) |
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