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Cercare Medical Neurosuited modules, including the Capillary Function module, is an image processing software package to be used by trained professionals, including physicians and medical technicians.
The software package runs on standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM (Digital Imaging and Communications in Medicine) compliant MR imaging devices.
Cercare Medical Neurosuite provides viewing capabilities, whereas the Capillary Function module provides analysis capabilities for functional and dynamic imaging datasets acquired with MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI).
The Capillary Function module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. In addition, the Capillary Function module's DWI technology is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.
Cercare Medical Neurosuite is a software-only device designed to streamline medical image processing by providing for the visualization and study of medical images. CMN can be installed on a customer PC or it can be accessed remotely using remote desktop technologies. CMN provides viewing, quantification, analysis and reporting capabilities. CMN is not intended as a dedicated PACS system for long term persistent storage of patient data.
CMN is software that is intended for use by trained professionals, including physicians and medical technicians. The software provides cerebral image processing capabilities. CMN is intended to be used as decision support software only and the clinician continues to provide all treatment decisions.
The software is intended to visualize and study neuroimaging by image viewing and registration of medical images obtained with MRI (Magnetic Resonance Image) technology.
CMN accepts and produces data sets in the DICOM format. DICOM is a standard format for storing and transmitting medical image data in vendor neutral format and is managed by the DICOM Standards Committee.
CMN is a platform that allows for the addition of certain modules for further analysis. One of these modules included in this submission is Capillary Function.
Capillary Function, when activated in the installed Cercare Medical Neurosuite, provides further functionalities for reading, writing, visualizing and studying medical images.
Capillary Function provides perfusion post-processing technologies, where dynamically acquired perfusion MRI series can be processed to yield information relevant for assessment of the hemodynamic status of a patient.
Capillary Function generates hemodynamic markers, which can be used for management of diseases with possibly compromised hemodynamic function, such as ischemic stroke and tumors.
The generated output maps can be viewed by standard DICOM image viewers. In addition, Capillary Function includes the possibility for post-processing diffusion-weighted imaging (DWI) MRI data. Post-processing of DWI data results in maps reflective of local water diffusion properties. The post-processed DWI-derived maps can be viewed in standard DICOM image viewers. Capillary Function thus works with MRI technology.
The provided text is a 510(k) summary for the Cercare Medical Neurosuite (CMN) with Capillary Function. It details the device's characteristics, indications for use, and a comparison to a predicate device (iSchemaView's RAPID). While it states that acceptance criteria were met, it does not provide specific numerical acceptance criteria or detailed results of the performance studies.
However, I can extract the information that is present and highlight what is missing based on your request.
Device: Cercare Medical Neurosuite (CMN) with Capillary Function
Indications for Use: Image processing software package for trained professionals (physicians, medical technicians) to perform image viewing, processing, and analysis of functional and dynamic MRI datasets (DWI and dynamic contrast-enhanced imaging data). Specifically, the Capillary Function module is used for visualization and analysis of dynamic imaging data to calculate parameters related to tissue flow (perfusion) and tissue blood volume, and to visualize local water diffusion properties from DWI data.
Here's the breakdown of your requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes that "The established acceptance criteria were reached in all tests conducted" but does not explicitly define these criteria or provide specific numerical results of the device performance against them. It generally states:
| Criterion Type | Acceptance Criteria (Not Explicitly Defined in Document) | Reported Device Performance (Summary) |
|---|---|---|
| Accuracy (Phantom Data) | Implicit: High correlation, low absolute bias, high multi-scale structural similarity index. | "The established acceptance criteria were reached in all tests conducted." (Bench testing with digital phantoms showed accurate representation of key processing parameters.) |
| Software Functionality | Implicit: Met all design requirements and specifications. | "Software performance, validation and verification testing demonstrated that the CMN system met all design requirements and specifications." |
| DICOM Compliance | Implicit: Full compliance with NEMA PS 3.1-3.20. | "CMN with Capillary Function complies with DICOM (Digital Imaging and Communications in Medicine)." |
| Safety | Implicit: No unacceptable risks. | "The CMN with Capillary Function performs as intended and presents no unacceptable risks to the intended patient population." |
| Substantial Equivalence | Implicit: Similar intended use, indications, technological characteristics, and principles of operation to predicate device. | "The non-clinical bench data support the safety of the device and demonstrate that CMN performs as intended in the specified use conditions. CMN is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the legally marketed Predicate device, RAPID (K172477)." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Description: The document refers to "bench testing including simulated digital phantoms and retrospective clinical data."
- Sample Size: Not specified. The exact number of digital phantoms or retrospective clinical cases used in the test set is not mentioned.
- Data Provenance:
- Country of Origin: Not specified for the retrospective clinical data.
- Retrospective/Prospective: Retrospective clinical data was used. Digital phantoms are simulated data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document mentions the retrospective clinical data was "primarily used for visual inspection," implying human expert review, but does not detail the nature or number of these experts. For digital phantoms, the "true parameter combinations were known," meaning the ground truth was inherent to the simulation design, not established by human experts.
4. Adjudication Method for the Test Set:
- Method: Not specified. For the retrospective clinical data, it states "primarily used for visual inspection," which generally implies a qualitative review, but no formal adjudication process (like 2+1 or 3+1 consensus) is described. For phantom data, ground truth was inherent to the simulation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
- MRMC Study: No, it does not appear that a formal MRMC study was done to compare human readers with and without AI assistance. The performance testing was comparative against a predicate device using bench testing (digital phantoms) and retrospective clinical data primarily for visual inspection, not assessing the impact on human reader performance.
- Effect Size: Not applicable, as no MRMC study was described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the performance data described ("bench testing including simulated digital phantoms and retrospective clinical data") appears to primarily evaluate the algorithm's performance in generating the output maps and parameters independently. The phrase "the CMN system provides accurate representation of key processing parameters" and "rigorous testing was conducted through digital phantoms where the true parameter combinations were known" suggests a standalone evaluation of the algorithm's output.
7. The Type of Ground Truth Used:
- For digital phantoms: The ground truth was known parameter combinations inherent to the simulated data. This is considered a form of "synthetic ground truth."
- For retrospective clinical data: The ground truth method is not explicitly defined for quantitative comparison, as this data was "primarily used for visual inspection due to the relative nature of most perfusion image biomarkers." This implies a qualitative assessment against an unspecified clinical or expert consensus. It does not mention pathology or outcomes data as ground truth.
8. The Sample Size for the Training Set:
- Not specified. The document focuses on the validation of the device and does not provide details about its development process, including the training set size.
9. How the Ground Truth for the Training Set was Established:
- Not specified. As the training set size is not provided, neither is how its ground truth was established.
§ 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).