(91 days)
Brainomix 360 Triage ICH is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow.
Brainomix 360 Triage ICH uses an artificial intelligence algorithm to analyze images for findings suggestive of a prespecified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device is intended to be used for the triage of non-contrast CT images of the brain acquired from adult patients in the acute setting, within 24 hours of the acute symptoms, or where this is unclear, since last known well (LKW) time. It is not intended to detect isolated subarachnoid hemorrhage. The device sends notifications to a neurovascular specialist that a suspected intracranial hemorrhage has been identified and recommends review of those images. Images can be previewed through a mobile application.
Images that are previewed through the mobile application are compressed and are for informational purposes only and not intended for diagnostic use beyond notification. 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 Triage ICH is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
Limitations:
· Brainomix 360 Triage ICH is not intended for mobile diagnostic use. Images viewed on a mobile platform are preview images and not for diagnostic interpretation.
- · Brainomix 360 Triage ICH has been validated and is intended to be used on GE and Philips scanners.
- · Brainomix 360 Triage ICH is not intended to detect isolated subarachnoid hemorrhage.
- · Brainomix 360 Triage ICH is not intended to be used on patients with recent (within 6 weeks) neurosurgery or endovascular neurointervention or recent (within 4 weeks) previous diagnosis of intracranial hemorrhage.
Contraindications:
Brainomix 360 Triage ICH is not suitable for use with scan data containing image features associated with:
- · tumors or abscesses
- · coils, shunts, embolization or movement artefacts
Brainomix 360 Triage ICH is not intended to be used for analyzing CT images in intracranial vascular pathologies such as arterial aneurysms, arteriovenous malformations or venous thrombosis.
Brainomix 360 Triage ICH is a radiological computer aided triage and notification software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server.
The Triage ICH module is a non-contrast CT processing module which operates within the integrated Brainomix 360 Platform to provide triage and notification of suspected intracranial hemorrhage (ICH). Brainomix 360 Triage ICH is a stand-alone software device which uses machine learning algorithms that uses advanced non adaptive imaging algorithms, artificial intelligence, and large data analytics to automatically identify suspected ICH on non-contrast CT (NCCT) imaging acquired from adult patients in the acute setting, within 24 hours of the onset of the acute symptoms, or where this is unclear, since last known well (LKW) time. The module is a priority notification to clinicians indicating the suspicion of ICH based on positive findings. Specifically, Brainomix 360 Triage ICH is optimized to detect and evaluate hyperdense volume in the parenchyma typically associated with acute intracranial hemorrhage (ICH). The Triage ICH module uses the basic services supplied by the Brainomix 360 Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image.
Brainomix 360 Triage ICH notification capabilities enable clinicians to review images via mobile app notification. Alternatively, intended users can also access the notification (a "Suspected hemorrhage" flag) and straightened images via the Brainomix 360 web user interface. Images that are previewed via mobile app are compressed, are for preview informational purposes only, and not intended for diagnostic use beyond notification.
The device is intended for use as an additional tool for assisting study triage within existing pathways. It does not replace any part of the current standard of care. It is designed to assist in prioritization of studies for reading within a worklist, in addition to any other pre-existing formal methods of study prioritization in place. Specifically, it does not remove cases from a reading queue and operates in parallel to the standard of care. This device is not intended to replace the usual methods of communication and transfer of information in the current standard of care.
Here's a breakdown of the acceptance criteria and the study details for the Brainomix 360 Triage ICH device, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Lower Bound of 95% CI) | Reported Device Performance (95% CI) |
|---|---|---|
| Sensitivity | 80% | 89.22% (83.50-93.49) |
| Specificity | 80% | 91.37% (86.42-94.90) |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 341 non-contrast Computed Tomography (NCCT) scans (studies).
- Data Provenance: The scans were obtained from 30 different hospitals and clinics in the U.S. The majority of patients (N=237) were scanned at Boston Medical Centre, with the remainder from 29 other referral hospitals in Massachusetts State. The data is retrospective.
3. Number of Experts and Qualifications for Ground Truth Establishment
- Number of Experts: Not explicitly stated, but mentioned as "experienced US board certified neuroradiologists."
- Qualifications of Experts: "Experienced US board certified neuroradiologists."
4. Adjudication Method for Test Set
- The text does not explicitly describe an adjudication method like 2+1 or 3+1. It states the ground truth was "established by experienced US board certified neuroradiologists," implying a consensus or individual expert review process without detailing a specific adjudication protocol.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. The study assessed the standalone performance of the AI algorithm and compared its notification time to the standard of care as reported by the predicate device.
6. Standalone Performance Study (Algorithm Only)
- Yes, a standalone performance study was done. The "retrospective study has been carried out to assess the standalone performance of the image analysis algorithm and notification functionality of Triage ICH."
7. Type of Ground Truth Used
- Expert Consensus: The ground truth was "established by experienced US board certified neuroradiologists, in the detection of intracranial hemorrhage (ICH) in the brain."
8. Sample Size for Training Set
- The document does not explicitly state the sample size used for the training set.
9. How Ground Truth for Training Set Was Established
- The document does not explicitly state how the ground truth for the training set was established. It only mentions that the device uses "machine learning algorithms that uses advanced non adaptive imaging algorithms, artificial intelligence, and large data analytics."
§ 892.2080 Radiological computer aided triage and notification software.
(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(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 notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone 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; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.