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The Zebra Head CT triage device is a software workflow tool designed to aid the clinical assessment of adult non-contrast head CT cases with features suggestive of intracranial hemorrhage in the medical care environment. HealthICH analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. HealthICH is not intended to direct attention to specific portions of an image or to anomalies other than intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases.

Zebra's HealthICH solution is a software product that automatically identifies suspected finding suggestive of Intracranial Hemorrhage and notifies the PACS/workstation of the presence of this critical finding in the scan. This notification allows for worklist prioritization of the identified scan and assists clinicians in viewing the prioritized scan before others. The device aim is to aid in the prioritization and triage of radiological medical images only.

Zebra's HealthICH Triage Device uses an artificial intelligence algorithm to analyze CT scans. The HealthICH is indicated for the analysis of non-contrast head CT scans. The algorithm output does not include an image and therefore it does not mark, highlight or direct users' attention to a specific location on the original CT scan.

The Zebra's HealthICH device works in parallel to and in conjunction with the standard of care workflow. After a head CT scan has been performed, a copy of the study is automatically retrieved and processed by the HealthICH device. The device performs the analysis of the study and return a notification about a suspected finding suggestive of Intracranial Hemorrhage to the PACS/workstation which prioritizes it through its worklist interface. The clinician is then able to review the study earlier than in standard of care workflow.

The primary benefit of the product is the ability to reduce the time it takes to notify physician to the presence of a critical finding such as suspected Intracranial Hemorrhage in the head CT scan.

The software does not recommend treatment or provide a diagnosis. It is designed as tool to assist the medical staff and hospital networks in workflow triaging by highlighting and prioritizing studies containing suspected findings. The final diagnosis is provided by a radiologist or other qualified physician after examining the original scan as determined by the clinical standard of care. The software is intended for use by radiologists and other qualified medical staff who read head CT scans on a regular basis

The following modules compose the HealthICH software:

Data input and validation: Following retrieval of a study, the validation feature assessed the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm.

HealthICH algorithm: Once a study has been validated, the algorithm analyzes the head CT for identification of suspected finding suggestive of intracranial hemorrhage.

IMA Integration feature:
HealthICH interacts with users through the PACS/workstation via the Zebra Imaging Analytics platform (IMA). It does not have a Graphical User Interface (GUI). The HealthICH sends the results of the study analysis to the Zebra Imaging Analytics Platform, which then distributes the HealthICH results to the PACS/workstation for prioritization

Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the Zebra Imaging Analytics Platform

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 427 anonymized head CT cases.
  • 199 intracranial hemorrhage positive cases
  • 228 intracranial hemorrhage negative cases
• Data Provenance: Retrospective cohort from USA and Israel.

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

• Number of Experts: Initially two, with a third senior expert in case of disagreement.
• Qualifications: US Board Certified neuro-radiologists. The third expert was a "more senior" US Board Certified neuro-radiologist.

4. Adjudication Method for the Test Set

• Adjudication Method: 2+1 (Two experts established ground truth, and if they disagreed, a third, more senior expert made the final determination).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The performance data provided is for the device operating stand-alone.

6. Standalone Performance (Algorithm Only) Study

• Yes, a standalone performance study was done. The text explicitly states: "The performance of the HealthICH device has been validated in retrospective stand-alone performance study..." and "The stand-alone detection accuracy was measured on this cohort respective to ground truth."

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (from US Board Certified neuro-radiologists).

8. Sample Size for the Training Set

• The document does not specify the sample size for the training set. It only discusses the validation/test set.

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. It focuses solely on the ground truth establishment for the validation/test set.

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