(119 days)
Yes
The device description explicitly states that the software "uses machine learning algorithms" and the intended use section mentions that imaging features are "synthesized by an artificial intelligence algorithm".
No
The device is a computer-aided diagnosis (CADx) software that assists clinicians in assessing and characterizing brain tissue abnormalities. It provides diagnostic information (ASPECTS score) but does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data." It also mentions it is "indicated for evaluation of patients presenting for diagnostic imaging workup."
Yes
The device is explicitly described as a "stand-alone software device" and a "medical image visualization and processing software package." While it interacts with hardware like servers, PACS, and potentially mobile devices for notification, its core functionality and regulatory classification are based on the software itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The Brainomix 360 e-ASPECTS software processes and analyzes CT image data, which are generated by a medical imaging device (CT scanner), not directly from a biological sample.
The device falls under the category of medical image analysis software, specifically a computer-aided diagnosis (CADx) tool.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data.
The software automatically registers images and uses an atlas to segment and analyze ASPECTS regions. Brainomix 360 e-ASPECTS extracts image data from individual voxels in the image to provide analysis and computer analytics and relates the analysis to the atlas defined ASPECTS regions. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECTS (Alberta Stroke Program Early CT) score.
Brainomix 360 e-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. Brainomix 360 e-ASPECTS provides information that may be useful in the characterization of ischemic brain tissue injury during image interpretation (within 24 hours from time last known well).
Brainomix 360 e-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment by providing highlighted ASPECTS regions and an automated editable ASPECTS score for clinician review. Brainomix 360 e-ASPECTS additionally provides a visualization of the voxels contributing to and excluded from the automated ASPECTS score, and a calculation of the voxel volume contributing to ASPECTS score.
Limitations:
-
- Brainomix 360 e-ASPECTS is not intended for primary interpretation of CT images. It is used to assist physician evaluation.
-
- The Brainomix 360 e-ASPECTS score should be only used for ischemic stroke patients following the standard of care.
-
- Brainomix 360 e-ASPECTS has only been validated and is intended to be used in patient populations aged over 21 years.
-
- Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation.
-
- Brainomix 360 e-ASPECTS has been validated and is intended to be used on Siemens Somatom Definition scanners.
Contraindications/ Exclusions/Cautions:
- Patient motion: Excessive patient motion leading to artifacts that make the scan technically inadequate.
- Hemorrhagic Transformation, Hematoma.
Product codes
POK
Device Description
Brainomix 360 e-ASPECTS (also referred to as e-ASPECTS in this submission) is a medical image visualization and processing software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server.
Brainomix 360 e-ASPECTS allows for the visualization, analysis and post-processing of DICOM compliant Non-contrast CT (NCCT) images which, when interpreted by a trained physician or medical technician, may yield information useful in clinical decision making.
Brainomix 360 e-ASPECTS is a stand-alone software device which uses machine learning algorithms to automatically process NCCT brain image data to provide an output ASPECTS score based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines.
The post-processing image results and ASPECTS score are identified based on regional imaging features and overlayed onto brain scan images. e-ASPECTS provides an automatic ASPECTS score based on the input CT data for the physician. The score includes which ASPECTS regions are identified based on regional imaging features derived from NCCT brain image data. The results are generated based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines and provided to the clinician for review and verification. At the discretion of the clinician, the scores may be adjusted based on the clinician's judgment.
Brainomix 360 e-ASPECTS can connect with other DICOM-compliant devices, for example to transfer NCCT scans from a Picture Archiving and Communication System (PACS) to Brainomix 360 e-ASPECTS software for processing.
Results and images can be sent to a PACS via DICOM transfer and can be viewed on a PACS workstation or via a web user interface on any machine contained and accessed within a hospital network and firewall and with a connection to the Brainomix 360 e-ASPECTS software (e.g. a LAN connection).
Brainomix 360 e-ASPECTS notification capabilities enable clinicians to preview images through a mobile application or via e-mail.
Brainomix 360 e-ASPECTS email notification capabilities enable clinicians to preview images via e-mail notification with result image attachments. Images that are previewed via e-mail are compressed, are for informational purposes only, and not intended for diagnostic use beyond notification.
Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests.
Brainomix 360 e-ASPECTS provides an automated workflow which will automatically process image data received by the system in accordance with pre-configured user DICOM routing preferences.
Once received, image processing is automatically applied. Once any image processing has been completed, notifications are sent to pre-configured users to inform that the image processing results are ready. Users can then access and review the results and images via the web user interface case viewer or PACS viewer.
The core of e-ASPECTS algorithm (excluding image loading or result output format) can be summarised in the following 3 key steps of the processing pipeline:
- Pre-processing: brain extraction from the three dimensional (3D) non-enhanced contrast CT 1. head dataset and its reorientation/normalization by 3D spatial registration to a standard template space.
-
- Delineation of the 20 (10 for each cerebral hemisphere) pre-defined ASPECTS regions of interest on the normalized 3D image.
-
- Image feature extraction and heatmap generation which consists of the computation of numerical values characterizing brain tissue, apply a trained predictive model to those features and generate a 3D heatmap from the models output for highlighting regions contributing towards the ASPECTS score.
The Brainomix 360 e-ASPECTS module is made available to the user through the Brainomix 360 platform. The Brainomix 360 platform is a central control unit which coordinates the execution image processing modules which support various analysis methods used in clinical practice today:
- Brainomix 360 e-ASPECTS (K221564) (predicate device)
- Brainomix 360 e-CTA (K192692)
- Brainomix 360 e-CTP (K223555)
- Brainomix 360 e-MRI (K231656)
- Brainomix 360 Triage ICH (K231195)
- Brainomix 360 Triage LVO (K231837)
- Brainomix 360 Triage Stroke (K232496)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT
Anatomical Site
Brain/Head
Indicated Patient Age Range
Over 21 years.
Intended User / Care Setting
Primary Users: Neuroradiologist/Clinician
Care Setting: Clinical/Hospital environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Standalone performance testing dataset:
- Sample size: 137 non-contrast CT scans
- Data source: Patients scanned for suspected acute ischemic stroke, from 3 different USA institutions. Data distributed from Siemens (75), GE (32), Philips (16) and Toshiba (14).
- Ground truth: Determined by the consensus of three board-certified US neuroradiologists.
Reader study dataset:
- Sample size: 140 NCCT scans
- Data source: Patients scanned in the clinical context of suspected acute stroke. Data distributed from Siemens (79), GE (36), Philips (19) and Toshiba (6).
- Ground truth: Determined by the consensus of three board-certified US neuroradiologists.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
Digital Phantom Validation Activities:
- Study type: Digital phantom evaluation
- Sample size: 110 synthetic datasets
- Performance metrics: Absolute Bias (upper 95% CI) = 7.61 (0.86 criteria).
- Key results: All 3 performance criteria were met, demonstrating good agreement between synthetic digital phantom volumetric values and calculated volumetric values by Brainomix 360 e-ASPECTS.
-
Standalone Performance Testing:
- Study type: Standalone performance testing
- Sample size: 137 non-contrast CT scans
- AUC: 83% (95% CI: 80-86%)
- Key results: Demonstrated accurate representation of key processing parameters under a range of clinically relevant parameters and perturbations; generalized performance for a range of typical patient demographics and clinically-relevant subgroups.
-
Reader Performance Testing:
- Study type: Multiple reader multiple case (MRMC) study
- Sample size: 140 NCCT scans
- MRMC: Comparison of the area under the curve (AUC) for readers with and without e-ASPECTS support showed a statistically significant improvement of 6.4%, from 78% without e-ASPECTS to 85% with e-ASPECTS (p=.03).
- Key results: Improvement in sensitivity (from 61% to 72%), and a small improvement in specificity (from 96% to 98%). Cohen's Kappa and weighted Kappa also improved significantly with versus without e-ASPECTS. Improvements were driven by non-expert readers. Readers tended to be more accurate when e-ASPECTS support was available.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Standalone Performance:
- Sensitivity: 69% (56-75%)
- Specificity: 97% (80-97%)
- AUC: 83% (95% Cl: 80-86%)
Reader Performance Testing:
- Sensitivity: improved from 61% to 72%
- Specificity: improved from 96% to 98%
- AUC: improved from 78% to 85%
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2060 Radiological computer-assisted diagnostic software for lesions suspicious of cancer.
(a)
Identification. A radiological computer-assisted diagnostic software for lesions suspicious of cancer is an image processing prescription device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography. The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user. Diagnostic and patient management decisions are made by the clinical user.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, and algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will improve reader performance as intended.
(iii) Results from performance testing protocols that demonstrate that the device improves reader performance in the intended use population when used in accordance with the instructions for use. The performance assessment must be based on appropriate diagnostic accuracy measures (
e.g., receiver operator characteristic plot, sensitivity, specificity, predictive value, and diagnostic likelihood ratio). The test dataset must contain sufficient numbers of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, concomitant diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and imaging equipment.(iv) Standalone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; and description of verification and validation activities including system level test protocol, pass/fail criteria, results, and cybersecurity).(2) Labeling must include:
(i) A detailed description of the patient population for which the device is indicated for use.
(ii) A detailed description of the intended reading protocol.
(iii) A detailed description of the intended user and recommended user training.
(iv) A detailed description of the device inputs and outputs.
(v) A detailed description of compatible imaging hardware and imaging protocols.
(vi) Warnings, precautions, and limitations, including situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality or for certain subpopulations), as applicable.(vii) Detailed instructions for use.
(viii) A detailed summary of the performance testing, including: Test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders (
e.g., lesion and organ characteristics, disease stages, and imaging equipment).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
February 14, 2025
Brainomix Limited Delanyo Mensah Regulatory Affairs Specialist First Floor, Seacourt Tower West Way Oxford. OX2 0JJ United Kingdom
Re: K243294
Trade/Device Name: Brainomix 360 e-ASPECTS Regulation Number: 21 CFR 892.2060 Regulation Name: Radiological computer-assisted diagnostic software for lesions suspicious of cancer Regulatory Class: Class II Product Code: POK Dated: October 18, 2024 Received: January 17, 2025
Dear Delanyo Mensah:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510/k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change reguires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243294
Device Name Brainomix 360 e-ASPECTS
Indications for Use (Describe)
Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data.
The software automatically registers images and uses an atlas to segment and analyze ASPECTS regions. Brainomix 360 e-ASPECTS extracts image data from individual voxels in the image to provide analysis and relates the analysis to the atlas defined ASPECTS regions. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECTS (Alberta Stroke Program Early CT) score.
Brainomix 360 e-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected in the total score. Brainomix 360 e-ASPECTS provides information that may be useful in the characterization of ischemic brain tissue injury during image interpretation (within 24 hours from time last known well).
Brainomix 360 e-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment by providing highlighted ASPECTS regions and an automated editable ASPECTS score for clinician review. Brainomix 360 e-ASPECTS additionally provides a visualization of the voxels contributing to and excluded from the automated ASPECTS score, and a calculation of the voxel volume contributing to ASPECTS score.
Limitations:
-
Brainomix 360 e-ASPECTS is not intended for primary interpretation of CT images. It is used to assist physician evaluation.
-
The Brainomix 360 e-ASPECTS score should be only used for ischemic stroke patients following the standard of care.
-
Brainomix 360 e-ASPECTS has only been validated and is intended to be used in patient populations aged over 21 years.
-
Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation.
-
Brainomix 360 e-ASPECTS has been validated and is intended to be used on Siemens Somatom Definition scanners.
Contraindications/ Exclusions/Cautions:
· Patient motion: Excessive patient motion leading to artifacts that make the scan technically inadequate.
· Hemorrhagic Transformation, Hematoma.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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Image /page/5/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon is a gradient of light blue to white, and the letters "AI" in the word "BRAINOMIX" are also in the same light blue gradient, while the rest of the letters are in dark gray.
510(K) Summary Brainomix Limited – Brainomix 360 e-ASPECTS
| Date Prepared: | 13Feb2025 |
|---|---|
| Applicant's Name: | Brainomix Limited |
| Applicant's Address: | First Floor, Seacourt Tower, West Way |
| Oxford, OX2 0JJ | |
| United Kingdom | |
| Official Contact: | Delanyo Mensah |
| +44 (0) 7375 967 695 | |
| regulatory@brainomix.com | |
| Device Proprietary Name: | Brainomix 360 e-ASPECTS |
| Regulation Name: | Radiological computer-assisted diagnostic software for lesions |
| suspicious of cancer | |
| Regulatory Class: | Class II |
| Product Code: | POK |
| Regulation Number: | 21 C.F.R. §892.2060 |
1. Predicate Device
Brainomix 360 e-ASPECTS is Substantially Equivalent to the following Legally Marketed device:
Trade Name: Brainomix 360 e-ASPECTS Manufacturer: Brainomix Limited Regulation Number: 21 C.F.R. §892.2060 Regulatory Class: Class II Regulation Name: Radiological computer-assisted diagnostic software for lesions suspicious of cancer Product Code: POK Submission Number: K221564
2. Reference Device
Trade Name: Rapid ASPECTS (v3) Manufacturer: iSchemaView, Inc. Regulation Number: 21 C.F.R. §892.2060 Regulatory Class: Class II Regulation Name: Radiological computer-assisted diagnostic software for lesions suspicious of cancer Product Code: POK Submission Number: K232156
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Image /page/6/Picture/0 description: The image shows the logo for BRAINOMIX. To the left of the company name is a teal-colored graphic that resembles a brain. The company name is in all caps and the "A" in BRAINOMIX is also teal.
3. Device Description
Brainomix 360 e-ASPECTS (also referred to as e-ASPECTS in this submission) is a medical image visualization and processing software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server.
Brainomix 360 e-ASPECTS allows for the visualization, analysis and post-processing of DICOM compliant Non-contrast CT (NCCT) images which, when interpreted by a trained physician or medical technician, may yield information useful in clinical decision making.
Brainomix 360 e-ASPECTS is a stand-alone software device which uses machine learning algorithms to automatically process NCCT brain image data to provide an output ASPECTS score based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines.
The post-processing image results and ASPECTS score are identified based on regional imaging features and overlayed onto brain scan images. e-ASPECTS provides an automatic ASPECTS score based on the input CT data for the physician. The score includes which ASPECTS regions are identified based on regional imaging features derived from NCCT brain image data. The results are generated based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines and provided to the clinician for review and verification. At the discretion of the clinician, the scores may be adjusted based on the clinician's judgment.
Brainomix 360 e-ASPECTS can connect with other DICOM-compliant devices, for example to transfer NCCT scans from a Picture Archiving and Communication System (PACS) to Brainomix 360 e-ASPECTS software for processing.
Results and images can be sent to a PACS via DICOM transfer and can be viewed on a PACS workstation or via a web user interface on any machine contained and accessed within a hospital network and firewall and with a connection to the Brainomix 360 e-ASPECTS software (e.g. a LAN connection).
Brainomix 360 e-ASPECTS notification capabilities enable clinicians to preview images through a mobile application or via e-mail.
Brainomix 360 e-ASPECTS email notification capabilities enable clinicians to preview images via e-mail notification with result image attachments. Images that are previewed via e-mail are compressed, are for informational purposes only, and not intended for diagnostic use beyond notification.
Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests.
Brainomix 360 e-ASPECTS provides an automated workflow which will automatically process image data received by the system in accordance with pre-configured user DICOM routing preferences.
Once received, image processing is automatically applied. Once any image processing has been completed, notifications are sent to pre-configured users to inform that the image processing
7
Image /page/7/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The "A" in "BRAINOMIX" is a slightly different color than the rest of the letters. The brain icon is a gradient of blue and green.
results are ready. Users can then access and review the results and images via the web user interface case viewer or PACS viewer.
The core of e-ASPECTS algorithm (excluding image loading or result output format) can be summarised in the following 3 key steps of the processing pipeline:
- Pre-processing: brain extraction from the three dimensional (3D) non-enhanced contrast CT 1. head dataset and its reorientation/normalization by 3D spatial registration to a standard template space.
-
- Delineation of the 20 (10 for each cerebral hemisphere) pre-defined ASPECTS regions of interest on the normalized 3D image.
-
- Image feature extraction and heatmap generation which consists of the computation of numerical values characterizing brain tissue, apply a trained predictive model to those features and generate a 3D heatmap from the models output for highlighting regions contributing towards the ASPECTS score.
The Brainomix 360 e-ASPECTS module is made available to the user through the Brainomix 360 platform. The Brainomix 360 platform is a central control unit which coordinates the execution image processing modules which support various analysis methods used in clinical practice today:
- Brainomix 360 e-ASPECTS (K221564) (predicate device)
- Brainomix 360 e-CTA (K192692)
- Brainomix 360 e-CTP (K223555)
- Brainomix 360 e-MRI (K231656)
- Brainomix 360 Triage ICH (K231195)
- Brainomix 360 Triage LVO (K231837)
- Brainomix 360 Triage Stroke (K232496)
4. Clinical Characteristics
The primary users of the Brainomix 360 platform are medical imaging professionals. The outputs generated by Brainomix 360 e-ASPECTS may be used by clinicians to inform onward treatment decisions as part of a wider set of other imaging to identify signs of ischemic damage on a per-voxel basis and relate these to ASPECTS regions to determine a per-ASPECTS region result and an overall ASPECTS score. Clinicians can edit the automated ASPECTS score based on their interpretation of both the unprocessed NCCT scan and the e-ASPECTS processing results. The following figure provides a general layout of the ASPECTS display image as provided from Brainomix 360 e-ASPECTS.
8
Image /page/8/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon is split into two halves, with the left half being a solid teal color and the right half being an outline of the same color. The "AI" in "BRAINOMIX" is also teal, while the rest of the letters are a dark gray color.
Head office First Floor, Seacourt Tower, West Way Oxford OX2 0JJ, United Kingdom
Image /page/8/Picture/2 description: The image shows a brain scan with an ASPECTS score of 7. The scan on the left is labeled as 'Unannotated scan' and shows a standard view of the brain. The scan on the right, labeled 'Results', has areas highlighted in red and yellow, indicating regions of interest or concern. The heatmap indicates that 27 ml is contributing to the e-ASPECTS score on the right side.
5. Intended Use / Indications for Use
Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data.
The software automatically registers images and uses an atlas to segment and analyze ASPECTS regions. Brainomix 360 e-ASPECTS extracts image data from individual voxels in the image to provide analysis and computer analytics and relates the analysis to the atlas defined ASPECTS regions. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECTS (Alberta Stroke Program Early CT) score.
Brainomix 360 e-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. Brainomix 360 e-ASPECTS provides information that may be useful in the characterization of ischemic brain tissue injury during image interpretation (within 24 hours from time last known well).
Brainomix 360 e-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment by providing highlighted ASPECTS regions and an automated editable ASPECTS score for clinician review. Brainomix 360 e-ASPECTS additionally provides a visualization of the voxels contributing to and excluded from the automated ASPECTS score, and a calculation of the voxel volume contributing to ASPECTS score.
Limitations:
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- Brainomix 360 e-ASPECTS is not intended for primary interpretation of CT images. It is used to assist physician evaluation.
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- The Brainomix 360 e-ASPECTS score should be only used for ischemic stroke patients following the standard of care.
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Image /page/9/Picture/0 description: The image shows the logo for Brainomix. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon is a gradient of light blue to white, and the letters "AI" in the word "BRAINOMIX" are also in the same light blue color, while the rest of the letters are in a dark gray color.
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- Brainomix 360 e-ASPECTS has only been validated and is intended to be used in patient populations aged over 21 years.
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- Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation.
- ഗ് Brainomix 360 e-ASPECTS has been validated and is intended to be used on Siemens Somatom Definition scanners.
Contraindications/ Exclusions/Cautions:
- . Patient motion: Excessive patient motion leading to artifacts that make the scan technically inadequate.
- Hemorrhagic Transformation, Hematoma.
6. Technological Characteristics
Brainomix 360 e-ASPECTS principal workflow for NCCT includes the following key steps:
- NCCT image loading.
- . Automated image analysis and processing to identify and visualize the voxels which have been included in the ASPECTS score and the voxels which have been excluded from the ASPECTS score (also referred to as a 'heatmap').
- . Automated image analysis and processing to register the subject image to an atlas to segment and highlight ASPECTS regions and to display whether or not each region is qualified as contributing to the ASPECTS score.
- . Notifications and alerts sent to users.
- . Generation of a summary results report.
- Presentation of results for review and analysis by users.
Once the user has been notified of availability of the ASPECTS results, including the ASPECTS score, indication of affected side, affected ASPECTS regions and voxel-wise analysis (shown as a heatmap of voxels 'contributing to e-ASPECTS score' and a heatmap of voxels 'excluded from e-ASPECTS score') can be exported as a report and/or sent to the PACS.
7. Performance Data
Summary of Digital Phantom Validation Activities 7.1
Digital phantom evaluation was performed to validate the "volume contributing to e-ASPECTS" output as calculated by Brainomix 360 e-ASPECTS where performance criteria were derived from the literature (Cereda, et al., 2016). For the comparison of the volumes computed by the sum of the voxels contributing to the e-ASPECTS score against the synthetic volumes (n=110, synth datasets) of the digital phantom values, 3 metrics were derived and assessed against a performance requirement value previously derived from the literature. Those metrics with their associated threshold were 1) absolute bias of the difference between volumes computed and ground truth ( 0.86). The testing demonstrated that all 3 performance criteria were met and evidenced a good agreement between the synthetic digital phantom volumetric values (mL) and the calculated volumetric values (mL) by Brainomix 360 e-ASPECTS. This is summarized in Table 1 below.
| Metric Name | Value | Criteria | Pass/Fail |
|---|---|---|---|
| Absolute Bias (upper | |||
| 95% CI) | 7.61 | 0.86 | Pass |
Table 1 Summary of the results for performance evaluation with the 3 metrics (name, value, criteria)
Summary of Standalone Performance Testing 7.2
Standalone performance testing was conducted to comply with special controls for this device type. Standalone performance testing demonstrated that the proposed device provides accurate representation of key processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. The stand-alone performance testing demonstrates the generalized performance for a range of typical patient demographics which is the same as for the predicate device. The standalone performance dataset was additionally enriched to include a greater number of cases within late time-window sub-groups and cases with and without large vessel occlusions. Ground truth was determined by the consensus of three board-certified US neuroradiologists.
The standalone performance testing dataset comprised 137 non-contrast CT scans from patients scanned for suspected acute ischemic stroke, from 3 different USA institutions. The data was distributed from Siemens (75), GE (32), Philips (16) and Toshiba (14). Patients were admitted between March 2012 and August 2023. The median age was 70 years, and 51% were female. The distribution by race/ethnicity was that 35.5%(50) of patients were white, 10.2% (14) were Black/African America, 5.8% (8) were Hispanic or Latino, 1 (0.7%) was Asian, 1 (0.7%) was American Indian/ Native American, 2.2% (3) were Other and 43.8% (60) were unknown. Median NIHSS was 18 with an interquartile range of 11 to 22. 91 patients (66%) presented within 6 hours of time last seen well, 21 (15%) presented between 6 and 16 hours, 13 (9.5%) presented between over 16 hours and 12 (9%) were unknown onset time. 80 patients (58%) had an acute ICA or MCA large vessel occlusion ('with LVO') and 57 (42%) did not ('without LVO').
Region-level sensitivity, specificity, and AUC were calculated. Overall performance in 137 showed an area under the curve (AUC) of 83% (95% Cl: 80-86%), with a sensitivity of 69% (56-75%) and a specificity of 97% (80-97%). Case-level agreement, positive percentage agreement, and negative percentage agreement were analyzed for the overall cohort and for individual ASPECT regions and compared to pairwise agreement between the three truthers. The detailed results are reported in the labeling.
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Image /page/11/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon is a gradient of blue and green, while the "AI" in "BRAINOMIX" is also a similar gradient of blue and green, while the rest of the word is dark gray.
The standalone performance testing demonstrated that the e-ASPECTS performance generalized to a range of clinically-relevant subgroups (including stratification by time-window, LVO status, age, gender and clinical site). Consistent performance was also observed between the grouped cortical ASPECTS regions compared to grouped basal ganglia ASPECTS regions. Detailed performance testing results including these subgroups as well as performance for each ASPECTS region are reported in the labeling.
7.3 Summary of Reader Performance Testing
A multiple reader multiple case (MRMC) study was conducted to assess the impact of support from Brainomix 360 e-ASPECTS on reader performance. The reader study evaluated the performance of 7 clinical readers (1 'expert' neuroradiologist, and 6 'non-expert' radiologists or neurologists) when scoring the ASPECTS for 140 clinically-representative NCCT scans with and without the support of Brainomix 360 e-ASPECTS. Ground truth was determined by the consensus of three board-certified US neuroradiologists.
The reader study dataset comprised 140 NCCT scans from patients scanned in the clinical context of suspected acute stroke. Of these, 66 patients (47%) had confirmed LVO in the ICA or MCA M1; 56 (40%) had suspected stroke without LVC; and 18 (13%) were confounder or stroke mimic cases, with an alternative diagnosis to acute stroke and additional radiological findings. The median age was 68 years and 47% were female. Median NHSS was 18 (interquartile range: 10-22). 78 patients (56%) were scanned within 6 hours of time since symptom onset (or last known well); 22 patients (16%) were between 6-16 hours; 12 patients (9%) were over 16 hours; and 28 patients (20%) had unknown time of onset. The data was distributed from Siemens (79), GE (36), Philips (19) and Toshiba (6).
Comparison of the area under the curve (AUC) for readers with and without e-ASPECTS support showed a statistically significant improvement of 6.4%, from 78% without e-ASPECTS to 85% with e-ASPECTS (p=.03), which was the primary outcome measure of the study. This was driven by an improvement in sensitivity (from 61% to 72%), and a small improvement in specificity (from 96% to 98%). Cohen's Kappa and weighted Kappa also improved significantly with versus without e-ASPECTS.
Subgroup analyses showed that the improvements were driven by change in performance by nonexpert readers (radiologists and neurologists); the improvement was smaller but consistent positive in the expert reader (neuroradiologist). Stratification of cases was conducted and demonstrated an improvement in reader performance when aided by the device, though the performance improvement was not statistically significant, consistently across clinically-relevant subgroups, including by time since onset, LVO status, age, gender, and clinical site.
Out of 126 reads (18 confounder cases times seven readers), 18 reads (14.3%) changed when e-ASPECTS was used. 12 cases were not scored 10 with e-ASPECTS support compared to 10 without e-ASPECTS support. However, the misinterpretations by readers without e-ASPECTS support were of higher magnitude (ASPECTS scores of 4,5, or 6), compared to with e-ASPECTS (8 or 9), therefore no clinically significant impact was observed. Hence, the reads changed with versus without e-ASPECTS, as readers tended to be more accurate when e-ASPECTS support was available.
As the study used retrospective data, there were no specific safety endpoints in the reader study.
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Image /page/12/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in bold, sans-serif font. The brain icon is split into two halves, with the left half being a solid teal color and the right half being white. The letters "AI" in "BRAINOMIX" are also teal, while the rest of the letters are dark gray.
This study demonstrates substantial equivalence of the Brainomix 360 e-ASPECTS software for improving reader performance, compared to the predicate device. The results showed statistically significant improvement in the agreement between the readers and a reference standard when using the Brainomix 360 e-ASPECTS software compared to routine clinical practice.
8. Prescriptive Statement
Caution: Federal law restricts this device to sale by or on the order of a physician.
9. Safety and Effectiveness
Brainomix 360 e-ASPECTS has been designed, verified and validated in compliance with 21 CFR, Part 820.30 requirements. The device has been designed to meet the requirements associated with ISO 14971:2019 (risk management).
Cybersecurity 10.
Brainomix 360 e-ASPECTS has been designed to follow the FDA Cybersecurity Guidance and IEC 81001-5-1.
Substantial Equivalence 11.
The subject device, Brainomix 360 e-ASPECTS, provides new claims based on the comprehensive software verification and validation activities performed. The substantial equivalence comparison table (below) summarizes and compares the characteristics of the proposed and the predicate device, along with the reference device.
The proposed device (Brainomix 360 e-ASPECTS), predicate (Brainomix 360 e-ASPECTS, K221564) and reference device (Rapid ASPECTS (v3), K232156) are software packages that assist the user (neuroradiologist/ clinician) in the assessment and characterization of brain tissue abnormalities using non-contrast CT brain image data. The proposed device includes similar NCCT processing features and technological characteristics as compared to the predicate device, which provides viewing, quantification, analysis and reporting capabilities based on acquired DICOM compliant medical image data. The proposed and predicate device segment and analyze ASPECTS regions to aid in evaluation of adult patients presenting for diagnostic imaging workup, for evaluation of extent of disease. Therefore, the proposed device has substantially similar intended use and indications for use compared to the predicate device.
Where the proposed device differs from the predicate device are:
- . Voxel volume contributing to ASPECTS score: the proposed device displays a calculation of the volume of the voxels contributing to ASPECTS score which was not present in the predicate. The heatmap does not have an impact on clinical decisions beyond aiding the understanding of the automated ASPECTS score and as such, no risks associated with the use of the voxel volume feature have been identified. Validation of the heatmaps and resulting volumes of the
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Image /page/13/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon and the "A" in "BRAINOMIX" are colored in a gradient of teal, while the rest of the letters are dark gray.
voxels identified as contributing towards the ASPECTS score has been extensively validated through digital phantom testing, which corroborates that the proposed device is safe and effective and does not raise different questions of safety and effectiveness.
- . Removal of gating conditions: the proposed device removes a gating condition by which the user must confirm that the patient is confirmed with having an MCA or ICA occlusion. The performance of ASPECTS scoring was validated by comparing radiological ground truth in patients with suspected stroke and demonstrated that the proposed device improves the performance of representative users when evaluating ASPECTS in patients with suspected stroke. The dataset included cases with and without large vessel occlusion (LVO), and a subset of cases with alternative final diagnoses that are commonly encountered confounders in the population of suspected stroke patients. Therefore, the removal of the gating condition in proposed device does not raise new questions of safety or effectiveness compared to the predicate device.
- . Extension of use to 24 hours: the proposed device extends the timeframe of the device's usefulness to 24 hours since the patient is last known to be well. This change does not introduce any new or unanswered questions of safety and effectiveness of the device as validated through clinical study. The study included data from a broad range of times after last known well, including patients with a time since onset unknown up to 24 hours.
Substantial Equivalence Comparison 12.
| Characteristics/
Parameter | Proposed Device
Brainomix 360 e-ASPECTS
(K243294) | Predicate Device
Brainomix 360 e-ASPECTS
(K221564) | Reference Device
Rapid ASPECTS (v3)
(K232156) |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K243294 | K221564 | K232156 |
| Product Code | POK | POK | POK |
| Regulation Number | 21 CFR §892.2060 | 21 CFR §892.2060 | 21 CFR §892.2060 |
| Intended
Use/Indications for
Use | Brainomix 360 e-ASPECTS is a
computer-aided diagnosis
(CADx) software device used
to assist the clinician in the
assessment and
characterization of brain
tissue abnormalities using CT
image data. | Brainomix 360 e-ASPECTS is a
computer-aided diagnosis
(CADx) software device used
to assist the clinician in the
assessment and
characterization of brain
tissue abnormalities using CT
image data. | Rapid ASPECTS is a computer-
aided diagnosis (CADx)
software device used to assist
the clinician in the assessment
and characterization of brain
tissue abnormalities using CT
image data. |
| | The software automatically
registers images and uses an
atlas to segment and analyze
ASPECTS regions. Brainomix
360 e-ASPECTS extracts image
data from individual voxels in
the image to provide analysis
and computer analytics and
relates the analysis to the
atlas defined ASPECTS regions. | The software automatically
registers images and uses an
Atlas to segment and analyze
ASPECTS regions. Brainomix
360 e-ASPECTS extracts image
data from individual voxels in
the image to provide analysis
and computer analytics and
relates the analysis to the
atlas defined ASPECTS regions. | The Software automatically
registers images and segments
and analyzes ASPECTS Regions
of Interest (ROIs). Rapid
ASPECTS extracts image data
for the ROI(s) to provide
analysis and computer
analytics based on
morphological characteristics.
The imaging features are then
synthesized by an artificial |
| Characteristics/
Parameter | Proposed Device
Brainomix 360 e-ASPECTS
(K243294) | Predicate Device
Brainomix 360 e-ASPECTS
(K221564) | Reference Device
Rapid ASPECTS (v3)
(K232156) |
| | The imaging features are then
synthesized by an artificial
intelligence algorithm into a
single ASPECTS (Alberta Stroke
Program Early CT) score. | The imaging features are then
synthesized by an artificial
intelligence algorithm into a
single ASPECTS (Alberta Stroke
Program Early CT) Score. | intelligence algorithm into a
single ASPECT (Alberta Stroke
Program Early CT) Score. |
| | Brainomix 360 e-ASPECTS is
indicated for evaluation of
patients presenting for
diagnostic imaging workup for
evaluation of extent of
disease. Extent of disease
refers to the number of
ASPECTS regions affected
which is reflected in the total
score. Brainomix 360 e-
ASPECTS provides information
that may be useful in the
characterization of ischemic
brain tissue injury during
image interpretation (within
24 hours from time last known
well). | Brainomix 360 e-ASPECTS is
indicated for evaluation of
patients presenting for
diagnostic imaging workup
with known MCA or ICA
occlusion, for evaluation of
extent of disease. Extent of
disease refers to the number
of ASPECTS regions affected
which is reflected in the total
score. Brainomix 360 e-
ASPECTS provides information
that may be useful in the
characterization of ischemic
brain tissue injury during
image interpretation (within 6
hours from time last known
well). | Rapid ASPECTS is indicated for
evaluation of adult patients
presenting for diagnostic
imaging workup, for
evaluation of extent of
disease. Extent of disease
refers to the number of
ASPECTS regions affected
which is reflected in the total
score. This device provides
information that may be
useful in the characterization
of early ischemic brain tissue
injury for ischemic stroke
patient (typically,