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Hyper Insight - ICH is a notification-only workflow tool for trained clinicians to identify patients' brain CT images and share them with medical specialists in parallel with standard patient care workflow. Hyper Insight - ICH uses deep learning-based AI algorithms to analyze images to find suspected intracranial hemorrhage and notifies and shares the findings to medical specialists. Identification of images with suspected intracranial hemorrhage is for notification purposes only, not diagnostic purposes.

In particular, this medical device analyzes non-contrast brain CT images, and if a suspected intracranial hemorrhage is identified, it sends a notification to medical specialists, who are advised to review these images may be previewed through the mobile app but are for informational purposes only and are not intended to be used for diagnostic purposes other than notifications and previews. The medical specialist who received the notification is responsible for reading the image in a diagnostic viewer.

Hyper Insight - ICH is limited to the purpose of analysis of image data and should not be used as a substitute for a full patient assessment or relied upon to make or confirm a diagnosis.

Hyper Insight - ICH is software as a medical device (SaMD) that detects intracranial hemorrhage (ICH) condition by analyzing non-contrast CT images. The software needs to be integrated with a third-party worklist application to receive analysis requests and the corresponding DICOM images and return the ICH findings (whether suspected ICH is found) to the worklist to alert the radiologists.

To help radiologists triage and prioritize reading of images for patients with ICH, Hyper Insight - ICH uses deep learning methods to automatically detect acute ICH in non-contrast head CT scans.

The software analyzes the input image and returns a binary prediction as to whether the exam suggests the presence of acute ICH. The Hyper Insight-ICH device is for notification purposes only and should be not used for final diagnosis.

Here's a summary of the acceptance criteria and study details for the Hyper Insight - ICH device, based on the provided text:

Acceptance Criteria and Device Performance

Conclusion: The study met the pre-specified performance goals for sensitivity and specificity, as the lower bound of each confidence interval exceeded 80%.

Study Details

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

• Sample Size: 394 brain Computed Tomography (CT) images.
• Data Provenance: Obtained from 13 clinical sites in the U.S.
• Retrospective/Prospective: Retrospective study.

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

• Number of Experts: Not explicitly stated as a specific number, but referred to as "trained neuro-radiologists" and a "Reference Standard Establishment Committee."
• Qualifications: "Trained neuro-radiologists."

3. Adjudication Method for the Test Set:

• The text states the clinical sensitivity was "evaluated against the reading results of intracranial hemorrhage from brain CT images by the Reference Standard Establishment Committee." It doesn't specify a numerical adjudication method (e.g., 2+1, 3+1).

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was it done? No, a traditional MRMC study comparing human readers with and without AI assistance was not conducted. The study evaluated the standalone performance of the AI algorithm.
• Effect Size: Not applicable, as an MRMC comparative effectiveness study was not performed.

5. Standalone Performance Study:

• Was it done? Yes, a standalone (algorithm only without human-in-the-loop performance) study was conducted. The device's sensitivity, specificity, and AUC were measured against an expert-established ground truth.

6. Type of Ground Truth Used:

• Expert consensus, established by a "Reference Standard Establishment Committee" comprised of "trained neuro-radiologists."

7. Sample Size for the Training Set:

• The document does not explicitly state the sample size for the training set. It only mentions the test set size.

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

• The document does not provide details on 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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