(185 days)
Brainomix 360 e-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 VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices. This includes DICOM files uploaded through a web browser interface.
Brainomix 360 e-CTP provides viewing and analysis capabilities for imaging datasets acquired with CT Perfusion.
The CT Perfusion analysis capabilities are 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.
Brainomix 360 e-CTP software allows for visualization of DICOM compliant CT (Computed Tomography) digital images. The software has been designed to run with off-the-shelf physical or virtual servers and provides for viewing, quantification, analysis, and reporting, as an aid to physician diagnosis.
The software consists of one processing module:
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- e-CTP Module- provides both analysis and viewing capabilities for brain CT Perfusion datasets for characterization of perfusion parameters in the image following the injection of a contrast bolus, and visualization of these parameters.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. It mentions "extensive performance validation testing and software verification and validation testing was conducted" and that "this performance validation testing demonstrated that the module provides accurate representation of key processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. Software performance, validation and verification testing demonstrated that the Brainomix 360 e-CTP met all design requirements and specifications."
However, it does not provide the following information from your request:
- A table of acceptance criteria and the reported device performance: No specific criteria or performance metrics are listed.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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: Not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states, "Brainomix 360 e-CTP software medical device may be used as a stand-alone tool," but it does not describe a standalone performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
In summary, while the document asserts that testing was conducted and the device met requirements, it lacks the specific details requested regarding acceptance criteria, study design, and results.
§ 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).