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510(k) Data Aggregation
(304 days)
The CT Dynamic Myocardial Perfusion (CT DMP) application is intended to assist clinicians in the visualization and diagnostic assessment of cardiac images focusing on the left ventricular myocardium: specifically providing qualitative myocardial blood flow measurements for CT images. The application supports axial, ECG gated CT images, consisting of multiple time shots within the same study of the same myocardial region over time (i.e., dynamic CT scans), after the injection of intravenous contrast. The application displays the results as a composite (single image that is calculated from a set of time course images at a single location) image.
The CT Dynamic Myocardial Perfusion (DMP) Application is intended for visualization and assessment of cardiac images focusing on the left ventricular myocardium: specifically providing qualitative myocardial blood flow measurements for CT images. The application supports axial, ECG gated CT images, consisting of multiple time shots within the same study of the same myocardial region over time. The application provides visualization and measurement tools for qualitative visualization and assessment of the input data. The data upon loading is first registered and filtered in the spatial and the temporal domain to reduce any noise variations, following which, the cardiac axes of the heart are detected using the automatic and manual tools. The images are displayed in the short-axis format and the clinician can then define the regions of interest using manual tools upon the short axis format. The software calculates measurements of myocardial blood flow, myocardial blood volume, time to peak, and peak enhancements, and provides tools for the clinician to assess these results. The user may save the results. The clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual assessment of the myocardial perfusion CT images. The qualitative assessment is to be used in conjunction with traditional visual assessment of CT images for the assessment of coronary artery disease.
The different components in the CT DMP application are:
CT DMP Models:
. CT DMPViewingModel - Main model in the application. Holds all the relevant data for results: volume, tissue, etc.
CT DMP Algorithms:
. Artery Automatic Detection
. Segmentation
. Cardiac Axes
. Spatio-temporal filtering
. Perfusion Maps Calculation
CT DMP Controllers:
. DMPBackgroundProcessing Used for activating long operations on a different thread
. DMPBatchController Creation of a combined spatial-temporal batch and cine
. ECGController - Used for showing ECG options.
CT DMP Tools:
. DMPSegmentationCorrectionTool
. AxesCorrectionTool
. ROITool
Here's a breakdown of the acceptance criteria and study information for the Philips CT Dynamic Myocardial Perfusion (DMP) Application, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Algorithm implementation evaluated through direct comparison of values obtained with predicate device. | Values obtained in the comparison were similar or the same under all test conditions when compared to Philips Brilliance Volume (K060987). |
| Design Specifications | Application met its design specifications. | Verification activities confirmed the function and implementation of the application as well as compliance with the risk management file. Full functionality testing covered all detailed requirements. |
| User Needs/Intended Use | Application meets intended use and defined customer needs outlines in the DRS DMP-002. | Validation activities confirm that the CT DMP Application meets user needs and intended uses. |
| Safety and Effectiveness | Demonstrates safety and effectiveness and substantial equivalence to predicate devices. | Results of verification and validation testing and risk analysis demonstrate safety and effectiveness. |
| Quality System Compliance | Manufactured in accordance with QSR and ISO 13485:2003. | Affirmed. |
| Risk Management | Potential hazards identified and controlled. | Affirmed; controlled through company procedures, FDA Guidance compliance, and Instructions for Use. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the test set in either the verification or validation activities. It mentions:
- Verification: "Testing included full functionality of CT DMP application and risk management file (RMF) related to defined requirements." and "CT DMP Algorithm implementation was evaluated through a direct comparison of values obtained by comparing the performance of CT DMP and the Philips predicate, Brilliance Volume K060987, under the same use conditions." This suggests testing against a set of scenarios or cases but not a specific number of patient samples.
- Validation: "Validation was performed externally to Philips on a laptop which met the HW requirements." Again, no specific sample size of patient data is mentioned for this external validation.
Data Provenance: The document does not provide information on the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts or their qualifications used to establish ground truth for any test set. The evaluation primarily focuses on direct comparison with a predicate device and internal testing against design specifications and user needs.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth or resolving discrepancies in the test set. The primary method described for algorithmic performance is direct comparison with a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on the device's standalone performance or its equivalence to existing predicate devices. There is no mention of evaluating human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described appears to be a standalone (algorithm only) performance evaluation. The "Verification Activities" Section 8 specifically states: "CT DMP Algorithm implementation was evaluated through a direct comparison of values obtained by comparing the performance of CT DMP and the Philips predicate, Brilliance Volume K060987, under the same use conditions." This directly assesses the algorithm's output against a known benchmark without explicit human interaction or interpretation as part of the primary performance metric.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The primary "ground truth" or reference standard for evaluating the algorithm's performance appears to be the output of a legally marketed predicate device (Philips Brilliance Volume K060987) under the same use conditions for algorithmic implementation. For other aspects, design specifications and defined user needs (DRS DMP-002) served as the reference. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth.
8. The Sample Size for the Training Set
The document does not specify the sample size for any training set. It focuses on verification and validation activities of the developed application.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how ground truth was established for any training set, as it does not mention a training set or the development process for machine learning aspects. The focus is on the verification and validation of the CT DMP Application's functionalities and adherence to specifications.
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