(61 days)
MR Cardiac Function Analysis
The MR Cardiac Function Analysis software option for use with Ziostation is intended for noninvasive post-processing of DICOM compliant cardiac MR images to semi-automatically calculate and display various functional parameters, such as left ventricular ejection fraction, end diastolic volume, end systolic volume, stroke volume, cardiac output, cardiac index, wall thickness, wall thickness ratio and regional wall motion display. These measurements can be used to assist the clinician in a cardiac evaluation.
MR Cardiac Function Analysis is an add-on software package designed to be used with the basic Ziostation image management system to further aid clinicians in their analysis of anatomy and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation software. The additional capabilities provided by this new device are:
MR Cardiac Function Analysis software post-processes ECG-gated cardiac MR images and extracts the following left ventricular parameters from multi-phase data.
- · Left ventricular ejection fraction
- End diastolic volume
- End systolic volume
- Stroke volume
- Cardiac output
- Cardiac Index
- Wall thickness
- Wall thickness ratio
- Wall movement
- Volume Curve
- Peak Ejection Rate
- Peak Filling Rate
The provided text describes the MR Cardiac Function Analysis software and its functionality butlacks detailed information regarding specific acceptance criteria, a formal study proving device performance against those criteria, or specific data pertaining to the accuracy and reliability of the measurements.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established, as this information is not present in the provided text.
Based on the available text, here's what can be inferred:
Acceptance Criteria and Device Performance Study Details:
As per the provided 510(k) summary, detailed acceptance criteria and a formal study demonstrating the device's performance against these criteria are not explicitly described. The text mentions "integration testing/verification testing prior to Beta validation" and "Software Beta testing/validation will be successfully completed prior to release," along with addressing "potential hazards by the Ziosoft Risk Management process." However, these statements refer to internal development and validation processes rather than a structured study proving specific performance metrics against clinical acceptance criteria for the parameters calculated by the device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Left ventricular ejection fraction | Not specified | Not specified |
| End diastolic volume | Not specified | Not specified |
| End systolic volume | Not specified | Not specified |
| Stroke volume | Not specified | Not specified |
| Cardiac output | Not specified | Not specified |
| Cardiac Index | Not specified | Not specified |
| Wall thickness | Not specified | Not specified |
| Wall thickness ratio | Not specified | Not specified |
| Wall movement | Not specified | Not specified |
| Volume Curve | Not specified | Not specified |
| Peak Ejection Rate | Not specified | Not specified |
| Peak Filling Rate | Not specified | Not specified |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: Not specified or indicated.
- Effect Size: Not applicable, as no MRMC study details are provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: The document describes the software as semi-automatically calculating and displaying parameters "to assist the clinician in a cardiac evaluation," implying a human-in-the-loop scenario. A standalone performance study without a human is not explicitly mentioned or detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not specified.
8. The sample size for the training set:
- Sample Size: Not specified.
9. How the ground truth for the training set was established:
- Method for Establishing Ground Truth: Not specified.
Summary of what is known from the document:
The 510(k) summary focuses on establishing substantial equivalence to a predicate device (Medis Medical Imaging Systems B.V.'s MRI-FLOW Analytical Software Package, K994282) rather than providing detailed clinical validation study results. It outlines the device's intended use, its ability to post-process DICOM compliant cardiac MR images to calculate various functional parameters, and its software-only nature. Regulatory compliance and general software testing (integration, verification, beta testing) are mentioned, but specific performance data or a formal clinical efficacy study is not provided in this summary.
§ 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).