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Brainomix 360 e-MRI 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-MRI provides both viewing and analysis capabilities for imaging datasets acquired with MRI including Perfusion Weighted Imaging (PWI) and Diffusion Weighted Imaging (DWI).

The DWI MRI analysis capabilities are used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.

The MRI PWI 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.

Device Description

Brainomix 360 e-MRI software allows for visualization of DICOM compliant MRI (Mage Resonance) 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 system consists of platform functionality and the e-MRI processing module. It provides both analysis and viewing capabilities for functional and dynamic imaging datasets acquired with MR including Diffusion Weighted Imaging (DWI) and Dynamic Susceptibility Contrast (DSC), which is the term used in the Brainomix 360 e-MRI software for perfusion-weighted imaging technique. The DWI capabilities are for visualization of local water diffusion properties from the analysis of diffusion-weighted MR data. The DSC capabilities are for the characterization of perfusion parameters in the injection of a contrast bolus, and visualization of these parameters.

e-MRI provides a wide range of basic image viewing, processing and manipulation functions, through multiple output formats. The Brainomix 360 platform has been designed to connect with other DICOM-compliant devices. This functionality enables the transfer of MRI scans from a Picture Archiving and Communication System (PACS) to Brainomix 360 e-MRI software for processing.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for Brainomix 360 e-MRI, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing substantial equivalence to a predicate device (iSchemaView's RAPID) and does not explicitly list quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, Dice score with thresholds) or present detailed reported device performance in this summary. Instead, the "Performance Testing Summary" section indicates that "extensive performance validation testing and validation testing was conducted" and that "Brainomix 360 e-MRI met all design requirements and specifications."

However, the "Technological Characteristics" table directly compares the functionalities and capabilities of the proposed device against the predicate. This comparison implicitly serves as a form of acceptance criteria, where the proposed device is deemed acceptable if its features align with or are a subset of the predicate's, and risks are appropriately managed.

Characteristic/Parameter	Predicate Device (RAPID)	Brainomix 360 e-MRI (Proposed Device)	Implicit Acceptance Criteria (based on equivalence)	Reported Device Performance (as stated in document)
Product Code	LLZ	LLZ	Must match predicate's product code.	Met (LLZ)
Regulation	21 CFR. §892.2050	21 CFR. §892.2050	Must match predicate's regulation number.	Met (21 CFR. §892.2050)
Indications for Use	Image processing software for viewing, processing, and analysis of brain images (CT Perfusion and MRI inc. DWI & Dynamic Analysis Module), visualizing local water diffusion and parameters related to tissue flow/blood volume. Used by trained professionals.	Image processing software for viewing, processing, and analysis of images (MRI inc. PWI & DWI), visualizing local water diffusion and parameters related to tissue flow/blood volume. Used by trained professionals. (Note: No CT capabilities)	Must be substantially similar; subset of predicate's OK.	Substantially similar, but without CT capabilities, which is presented as reducing risks.
Functional Overview	Visualization and study of tissue changes in digital images captured by CT and MRI. Provides viewing and quantification.	Same but with no CT capabilities.	Must align, accepting a subset.	Met (MRI visualization, viewing, quantification, analysis, and reporting)
Environment of Use	Clinical/Hospital environment	Same	Must match.	Met (Clinical/Hospital environment)
Primary Users	Trained professionals (physicians, medical technicians)	Same	Must match.	Met (Trained professionals - physicians, medical technicians)
Basic PACS Functions	View, process, analyze medical images. Performs standard PACS functions (querying, listing).	Same	Must match.	Met (Same as predicate, indicating ability to view, process, and analyze, and perform standard PACS functions)
Computer Platform	Standard off-the-shelf server or virtual server	Same	Must match.	Met (Standard off-the-shelf server or virtual server)
DICOM Compliance	Yes	Same	Must match.	Met (Fully DICOM compliant, NEMA PS 3.1 - 3.20)
Data Acquisition	Acquires medical image data from DICOM compliant imaging devices and modalities	Same	Must match.	Met (Acquires medical image data from DICOM compliant imaging devices and modalities)
Data/Image Types	MRI, CT	MRI (No CT)	Must be a subset or equivalent.	Met (MRI data, specifically PWI and DWI)
CT Capabilities	CT Perfusion (CTP)	None	Proposed device does not require CT capabilities.	Met (By not having CT capabilities, aligns with its specific indications for use)
MRI Capabilities	Diffusion Weighted Image (DWI) Perfusion Weighted Image (PWI)	Same	Must match.	Met (DWI and PWI (referred to as DSC in the device description))
Computed Parameters (PWI)	CBF, CBV, MTT, Tmax	Same (CBF, CBV, MTT, Tmax) + TTP (additional)	Must include predicate's; additional is acceptable.	Met (Includes predicate's parameters and adds TTP)
Computed Parameters (DWI)	ADC, Trace, Isotropic DWI (isoDWI), Fractional Anisotropy (FA) and Color FA	ADC, Trace, Isotropic DWI (isoDWI) (No FA and Color FA)	Must include relevant; subset is often acceptable if not critical difference.	Met (Provides ADC, Trace, isoDWI, which are key for DWI analysis, with the absence of FA/Color FA not constituting a substantial difference for the intended use.)
Measurement Tools (MRI)	AIF/VOF, Time-course, Motion Correction, Mask, Volumetry, Mismatch volume/ratio, Hypoperfusion intensity ratio, Export files to PACS/DICOM, Acquire, transmit, process, store.	Same (excluding CT Measurement Tools, and replacing "Volumetry" with "Region of Interest (ROI) and Volumetry")	Must match or be functionally equivalent.	Met (Provides AIF/VOF, Time-course, Motion Correction, Mask, ROI and Volumetry, Mismatch volume/ratio, Export files to PACS/DICOM, Acquire, transmit, process, store.)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the validation studies. It only generally refers to "extensive performance validation testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, no effect size of human readers' improvement with vs. without AI assistance is provided. The submission focuses on standalone device performance and substantial equivalence to a predicate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone performance evaluation was done. The "Performance Testing Summary" states: "extensive performance validation testing and validation testing was conducted for the Brainomix 360 e-MRI module. 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." This implies that the algorithm's output was assessed independently.

7. The Type of Ground Truth Used:

The document does not explicitly specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the nature of image processing software for analyzing MRI data (PWI and DWI), it is highly probable that ground truth would have been established through expert review and interpretation of the imaging data, potentially with reference to clinical outcomes or other diagnostic information, but this is not confirmed in the summary provided.

8. The Sample Size for the Training Set:

The document does not provide any information regarding the sample size for the training set. It focuses on the validation for substantial equivalence rather than the development process.

9. How the Ground Truth for the Training Set Was Established:

The document does not provide information on how the ground truth for the training set was established, as it does not address the training set at all.

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