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510(k) Data Aggregation
(129 days)
icobrain-ctp
icobrain ctp is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VM ware, and can be used to perform image processing, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.
icobrain ctp provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated from a raw CTP scan are exported in the standard DICOM format and may be viewed on existing radiological imaging viewers.
The input images are CT perfusion images. During the pre-processing, each scan is loaded from the DICOM format: the image data and relevant dicom tags are extracted. The image processing block calculates the perfusion parameters and the volumes of the Tmax abnormality (defined as tissue with delayed arrival) and the CBF abnormality (defined as tissue with delayed arrival and critically decreased cerebral blood flow). Finally, the computed measurements are summarized into an electronic report. Optionally if requested, Tmax and CBF abnormalities segmentations are overlaid on the input images and image volumes of perfusion parameters maps are sent.
Here's an analysis of the acceptance criteria and study details for the icobrain-ctp device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several performance tests. The specific numerical acceptance criteria are not always explicitly stated in the same detail as the results, but the type of metric used and the general outcome can be inferred.
| Test Type | Metric/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy - Clinical Dataset (CBF & Tmax Abnormality Volumes vs. Reference Device) | Percentile 90 of the volume differences for both CBF abnormality and Tmax abnormality. | "All experiments passed the acceptance criteria." (Specific P90 values not provided, but implies they met the set thresholds) |
| Accuracy - Clinical Dataset (Unbiased CBF Abnormality Volume vs. Manual DWI Delineation) | Percentile 90 of the volume differences. | "All experiments passed the acceptance criteria." (Specific P90 values not provided) |
| Accuracy - Clinical Dataset (ROI Volume vs. Manual Annotation) | Percentile 90 of the volume differences. | "All experiments passed the acceptance criteria." (Specific P90 values not provided) |
| Reproducibility - Clinical Dataset (Tmax & CBF Abnormality Volumes on Test/Retest) | Percentile 90 of the volume differences for both CBF abnormality and Tmax abnormality. | "All experiments passed the acceptance criteria." (Specific P90 values not provided) |
| Accuracy - Digital Phantom (Perfusion Parameter Maps: CBV, CBF, MTT) | Correlation, Percentile 90 absolute difference, and mean relative difference between ground truth and estimated values. | "In the digital phantom, the correlation for each perfusion parameter was above 0.90." (Implies P90 absolute difference and mean relative difference also met their criteria, though specific values are not given) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: Not explicitly stated, but mentioned as "a dataset of clinical CTP scans."
- Sample Size for Digital Phantom Test Set: Not explicitly stated, but described as "a wide range of clinically relevant values of perfusion parameters."
- Data Provenance (Clinical Test Set): "The subjects upon whom the software was tested include stroke patients." No specific country of origin is mentioned. It is described as a "clinical dataset," which typically implies retrospective use of existing patient data, but it is not definitively stated as prospective or retrospective.
- Data Provenance (Digital Phantom Test Set): Generated by simulating tracer kinetic theory.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document mentions "manually delineated DWI images" and "manually annotated ROI" for establishing ground truth in the clinical accuracy experiments. However:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified (e.g., specific medical specialty, years of experience).
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated. The text refers to "manually delineated DWI images" and "manually annotated ROI," which suggests expert involvement, but whether multiple experts were involved and an adjudication process (like 2+1 or 3+1) was used is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not described in the provided text. The performance evaluations focus on the algorithm's standalone performance against established ground truth (either from reference devices, manual expert delineation, or digital phantoms).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone (algorithm-only) performance evaluations. The device's output (e.g., Tmax and CBF abnormality volumes, perfusion parameter maps) is compared directly to reference data or ground truth without human interaction as part of the primary outcome assessment.
7. The Type of Ground Truth Used
- Clinical Dataset:
- Comparison to a "reference device" for CBF and Tmax abnormality volumes.
- "Manually delineated DWI images" for unbiased CBF abnormality volume.
- "Manually annotated ROI" for ROI volume.
- Digital Phantom Dataset: Ground truth generated by "simulating tracer kinetic theory" for perfusion parameters (CBV, CBF, MTT).
8. The Sample Size for the Training Set
The document does not provide any information about the training set size or methodology. The performance testing section focuses solely on validation data.
9. How the Ground Truth for the Training Set Was Established
As no information is provided about the training set, there is also no information on how its ground truth was established.
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