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Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT (NCCT) images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of head NCCT images for large vessel occlusion (LVO) of the intracranial ICA and M1 or intracranial hemorrhage (ICH). Specifically, the device is intended to be used for the triage of images 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. It is not intended to detect symmetrical bilateral MCA occlusions.

Brainomix 360 Triage Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected NCCT LVO or ICH on the Brainomix server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO or ICH findings via a web user interface or mobile application. Notifications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification.

The device does not alter the original medical image, and it is not intended to be used as a primary diagnostic device. The results of Brainomix 360 Triage Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.

Cautions:

• All patients should get adequate care for their symptoms, including angiography and/or other appropriate care per the standard clinical practice, irrespective of the output of Brainomix 360 Triage Stroke.
• Brainomix 360 Triage Stroke is not intended to be a rule-out device and for cases that have been processed by the device without notification for "Suspected LVO" should not be viewed as indicating that LVO is excluded. All cases should undergo angiography, per the standard stroke workup.

Limitations:

1. Brainomix 360 Triage Stroke is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation.
2. Brainomix 360 Triage Stroke does not replace the need for angiography in ischemic stroke workup - it provides workflow prioritization and notification only.
3. Brainomix 360 Triage Stroke has been validated and is intended to be used on Siemens, GE and Philips scanners.
4. Brainomix 360 Triage Stroke 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 stroke.
5. Brainomix 360 Triage Stroke is not intended to detect symmetrical bilateral MCA occlusions.

Contraindications:
Brainomix 360 Triage Stroke is not suitable for use with scan data containing image features associated with:

• tumours or abscesses
• coils, shunts, embolization or movement artifacts
• intracranial vascular pathologies such as arterial aneurysms, arteriovenous malformations or venous thrombosis.

Brainomix 360 Triage Stroke (also referred to as Triage Stroke in this submission) 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. Triage Stroke is a non-contrast CT processing software-only medical device which operates within the integrated Brainomix 360 Platform to provide triage and notification prioritization of suspected large vessel occlusion (LVO) or intracranial hemorrhage (ICH). The device uses machine learning algorithms such as advanced non adaptive imaging algorithms, artificial intelligence, and large data analytics.

Brainomix 360 Triage Stroke is available to users in three configurations, featuring three individual processing modules:

• Triage ICH Module, which can only flag positive findings of suspected ICH;
• Triage Stroke Module, which can flag positive findings of suspected ICH or LVO; And
• NCCT LVO Module, which can flag positive finding of suspected LVO

The Triage ICH Module automatically identifies suspected ICH, the NCCT LVO module automatically identifies suspected LVO, while the Triage Stroke Module automatically identifies suspected ICH or LVO on non-contrast CT (NCCT) imaging acquired from adult patients in the acute setting, within 24 hours of the onset of acute symptoms, or where this is unclear, since last known well (LKW) time. The output of the device is a priority notification to clinicians indicating the suspicion of just ICH for Triage ICH Module, the suspicion of just LVO for the NCCT LVO Module, and suspicion of ICH or LVO for Triage Stroke Module based on positive findings. Specifically, the ICH analysis algorithm is optimized to identify findings of hyperdense volume in the parenchyma typically associated with acute intracranial hemorrhage; and the NCCT LVO suspicion uses the combined analysis of the ASPECTS and hyperdense vessel sign (HDVS) algorithms to identify hyper attenuation in vessels and hypodense regions typically associated with a large vessel occlusion in a non-contrast CT scan.

Brainomix 360 Triage Stroke is not intended to detect symmetrical bilateral MCA occlusions. The device uses the basic services supplied by the Brainomix 360 Platform including DICOM processing, job management, imaging module execution and imaging output including notification and compressed image.

Brainomix 360 Triage Stroke notification capabilities enable clinicians to review and preview images via mobile app notification. Alternatively, intended users can also access the notification (a "Suspected LVO" or "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 patient 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 or informal 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.

The Brainomix 360 Triage Stroke device 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 (K243294)
• Brainomix 360 e-CTA (K242123)
• 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) (predicate device)

The provided document describes the acceptance criteria and the study that proves the device meets those criteria for the Brainomix 360 Triage Stroke device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT (NCCT) images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of head NCCT images for large vessel occlusion (LVO) of the intracranial ICA and M1 and intracranial hemorrhage (ICH). Specifically, the device is intended to be used for the trage of images 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 and symmetrical bilateral MCA occlusions.

Brainomix 360 Triage Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected NCCT LVO or ICH on the Brainomix server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO or ICH findings via a web user interface or mobile applications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification.

The device does not alter the original mage, and it is not intended to be used as a primary diagnostic device. The results of Brainomix 360 Triage Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.

Brainomix 360 Triage Stroke 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 Stroke module is a non-contrast CT processing module which operates within the integrated Brainomix 360 Platform to provide triage and notification of suspected large vessel occlusion (LVO) and intracranial hemorrhage (ICH). Brainomix 360 Triage Stroke is a stand-alone software device which uses machine learning algorithms that uses advanced non adaptive imaging artificial intelligence, and large data analytics to automatically identify suspected LVO and ICH on non-contrast CT (NCCT) imaging 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. The output of the module is a priority notification to clinicians indicating the suspicion of LVO or ICH based on positive findings. Specifically, Brainomix 360 Triage Stroke's ICH analysis is optimized to identify findings of hyperdense volume in the parenchyma typically associated with acute intracranial hemorrhage; and the NCCT LVO suspicion uses the combined analysis of the ASPECTS and hyperdense vessel sign (HDVS) algorithms. It is not intended to detect isolated subarachnoid hemorrhage and symmetrical bilateral MCA occlusions. The Triage Stroke 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.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Device Name: Brainomix 360 Triage Stroke

Indications for Use: Radiological computer aided triage and notification software for analysis of non-contrast head CT (NCCT) images to assist workflow triage by flagging and communicating suspected positive findings of large vessel occlusion (LVO) of the intracranial ICA and M1 and intracranial hemorrhage (ICH).

Study Details

1. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 267 cases (40 ICH positive, 112 LVO positive, 115 negative for ICH or LVO, 3 excluded due to technical inadequacy).
• Data Provenance: Retrospective study. The country of origin is not explicitly stated, but the company is based in the United Kingdom.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Three (for LVO cases). The number of experts for ICH cases is implied by "previously truthed," likely referring to the K231195 submission, but not specified in this document.
• Qualifications of Experts: Experienced US board-certified neuroradiologists.

3. Adjudication Method for the Test Set

• Adjudication Method: Consensus (for LVO cases). For ICH cases, the method is "as described in the standalone study for our previously cleared device," but not detailed here.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Was an MRMC study done? Yes, a reader study was conducted to compare NCCT LVO sensitivity of the device to that of radiologists.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance:
  • The study compared the device's standalone sensitivity to the sensitivity of human readers. It did not directly measure how human readers improve with AI assistance (i.e., human-in-the-loop performance with AI vs. without AI).
  • Device's standalone sensitivity: 68.75%
  • All readers (experts and non-experts) sensitivity: 47.94% (95% Cl: 37.91-57.97%)
  • Difference between device's sensitivity and all readers: 20.52% (95% Cl: 8.26-32.78%)
  • General radiologists (non-experts) sensitivity: 47.18% (95% Cl: 33.62-60.75%)
  • Difference between device and non-expert sensitivity: 21.28% (95% Cl: 5.84-36.72%)
  • The study stated that the device passed "expert non-inferiority and non-expert superiority," implying the device performs at least as well as experts and better than non-experts in terms of sensitivity for LVO detection.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Was a standalone study done? Yes. The core performance data for ICH and NCCT LVO (sensitivity and specificity) represent the algorithm's standalone performance.

6. The Type of Ground Truth Used

• ICH Cases: NCCT imaging with additional clinical information (as described in a previous submission for a related device).
• LVO Cases: Acute CTA imaging and additional clinical information.
• Method of Ground Truth Establishment: Expert consensus (for LVO cases).

7. The Sample Size for the Training Set

• The document does not specify the sample size for the training set. It mentions the algorithm "uses advanced non adaptive imaging artificial intelligence, and large data analytics," which implies a training phase, but no details on size are provided.

8. How the Ground Truth for the Training Set was Established

• The document does not explicitly state how the ground truth for the training set was established. It only describes the ground truth establishment for the test set.

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