(197 days)
StrokeViewer Perfusion is an image processing software package intended to provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients. It is to be used by medical imaging professionals who analyze dynamic perfusion studies, including but not limited to physicians such as neurologists, and radiologists.
The software is packed as a Docker container allowing installation on a standard "off-the-shelf" computer or a virtual platform. The software can be used to perform image viewing, processing, and analysis of brain CT perfusion images (CTP) images. Data and images are acquired through DICOM compliant imaging devices.
StrokeViewer Perfusion is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time, which are visualized as colored perfusion maps including flow-related parameters and tissue blood volume quantification.
Contraindications:
- Bolus Quality: absent or inadequate bolus.
- Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate. .
- Presence of hemorrhage .
StrokeViewer Perfusion is an image processing application that runs on a standard "off-the-shelf" computer or a virtual platform, and can be used to perform image processing and analysis of CT perfusion images of the brain.
The software can receive, identify and extract DICOM information embedded in the imaging data. The output includes parametric maps related to tissue blood flow (perfusion) and tissue blood volume. Results of the analysis are exported as DICOM series and DICOM reports and can be sent to a preconfigured destination and can be reviewed on a compatible DICOM viewer Perfusion image analysis includes calculation of the following perfusion related parameters:
- . Cerebral Blood Flow (CBF)
- Cerebral Blood Volume (CBV)
- Mean Transit Time (MTT)
- Residue function time-to-peak (TMax) .
- . Arterial Input Function (AIF)
- Volume calculations of affected tissue based on Tmax and CBF abnormalities
The device description and overall fundamental scientific technology of the StrokeViewer Perfusion algorithm is equivalent to the predicate device (K182130) in addition to the listed reference devices within this submission.
Here's a summary of the acceptance criteria and study details for StrokeViewer Perfusion, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The available document does not provide a specific table of quantitative acceptance criteria and corresponding reported device performance values. It broadly states that "The results of algorithm performance testing showed that the device met performance goals and acceptance criteria."
However, it does describe the type of testing performed:
| Acceptance Criterion (Implicit) | Reported Device Performance (General) |
|---|---|
| Correlation with ground truth values on simulated datasets. | "The results of algorithm performance testing showed that the device met performance goals and acceptance criteria." |
| Functional performance and meeting design requirements. | "The results of software verification, and algorithmic testing demonstrate that StrokeViewer Perfusion meets all design requirements and specifications for its intended use." |
| Software validation (Unit, End-to-end, Reproducibility). | "The tests performed demonstrate that Perfusion in StrokeViewer performs as intended. All testing included within the respective sections of this submission uphold our belief that StrokeViewer is substantially equivalent to the predicate device (K182130)." |
| Adherence to risk management and consensus standards. | "All risk controls were identified, implemented, and mitigated according to hazards identified. All testing related to risk controls support the acceptance criteria outlined for our software requirement specifications." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "simulated datasets (Kudo digital phantom)" for non-clinical bench performance testing. It does not specify the exact number of simulated cases or provide a specific sample size for a "test set" in the context of clinical image data.
- Data Provenance: The testing was conducted using "simulated datasets (Kudo digital phantom) generated using simulating tracer kinetic theory." This implies the data is synthetic/simulated, not derived from real patients. Therefore, information regarding "country of origin" or "retrospective/prospective" is not applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Since the testing was performed on "simulated datasets (Kudo digital phantom)" where "ground truth values were calculated" based on tracer kinetic theory, the ground truth was established by the design of the simulation, not by human experts interpreting medical images. Therefore, no human experts were involved in establishing the ground truth for this specific non-clinical test set.
4. Adjudication Method for the Test Set
Not applicable, as ground truth was established by simulation design/calculation, not human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. The document explicitly states: "Clinical data was not required for this submission of the StrokeViewer Perfusion. We believe the safety and effectiveness of the proposed device was appropriately tested with non-clinical validation."
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the primary performance evaluation described is a standalone algorithmic assessment using simulated data: "Non-clinical bench performance testing was performed to assess Perfusion algorithm performance on simulated datasets (Kudo digital phantom) generated using simulating tracer kinetic theory. Correlations between the output of the StrokeViewer Perfusion device and the ground truth values were calculated."
7. Type of Ground Truth Used
The ground truth used for the non-clinical bench testing was derived from simulated tracer kinetic theory / calculated ground truth values within the Kudo digital phantom.
8. Sample Size for the Training Set
The document does not explicitly state the sample size of the training set used for the StrokeViewer Perfusion algorithm. The focus of this 510(k) summary is on the validation testing rather than the development or training process.
9. How the Ground Truth for the Training Set Was Established
The document does not provide details on how the ground truth for the training set was established. Given the nature of the validation testing using simulated data, it's plausible that similar simulated or engineered data with known ground truths were used for training, but this is not stated.
§ 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).