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510(k) Data Aggregation
(224 days)
syngo.CT Brain Hemorrhage is designed to assist the radiologist in prioritizing cases of suspected intracranial hemorrhage, also in the subarachnoid space, on non-contrast CT examinations of the head. It makes case-level output available to a CT scanner or other PACS system for worklist prioritization. The output is intended for informational purposes only and is not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a standalone diagnostic device.
The subject device syngo.CT Brain Hemorrhage is an image-processing software that uses an artificial intelligence algorithm to support qualified clinicians in the analysis and prioritization of non-contrast head CT images. It is a notification-only processing application that algorithmically identifies findings suspicious of acute intracranial hemorrhage (ICH) and acute subarachnoid hemorrhage (SAH). The subject device facilitates a parallel workflow, where cases suspected of presence of ICH or SAH are flagged. 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.
Here's a breakdown of the acceptance criteria and study details for the syngo.CT Brain Hemorrhage device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance (Intracranial Hemorrhage) | Reported Device Performance (Subarachnoid Hemorrhage) |
|---|---|---|
| Sensitivity ≥ 80% | 95.0% (95% CI: 92.5%-96.7%) | 86.1% (95% CI: 81.1%-90.0%) |
| Specificity ≥ 80% | 93.1% (95% CI: 90.5%-95.1%) | 85.2% (95% CI: 82.3%-87.7%) |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 900 anonymized head CT cases.
- Data Provenance: From 5 sites in the US and Europe. The distribution of positive (case with ICH) and negative (case without ICH) cases was approximately equal.
- Type: Retrospective (implied by "anonymized head CT cases from 5 sites").
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: 3
- Qualifications: US board-certified neuroradiologists with more than 10 years of experience.
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Adjudication method for the test set:
- Method: Majority read (e.g., 2 out of 3 experts agreed).
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study described is a standalone performance study.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the document explicitly states: "The performance of the syngo.CT Brain Hemorrhage device has been va alone performance study."
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The type of ground truth used: Expert consensus, established by the majority read of 3 US board-certified neuroradiologists.
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The sample size for the training set: 29,713 cases.
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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 mentions the training data size.
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(449 days)
syngo.CT Brain Hemorrhage is designed to assist the radiologist in prioritizing cases of suspected intracranial hemorrhage on non-contrast CT examinations of the head. It makes case-level output available to a CT scanner or other PACS system for worklist prioritization. The output is intended for informational purposes only and is not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a stand-alone diagnostic device.
The subject device syngo.CT Brain Hemorrhage is an image processing software that utilizes artificial intelligence learning algorithms to support qualified clinicians in analysis and prioritization of noncontrast head CT DICOM images by algorithmically identifying findings suspicious of acute intracranial hemorrhage. The subject device provides a pipeline for the analysis and identification of potential ICH as well as a finding notification mechanism.
Here's a breakdown of the acceptance criteria and the study proving the device's performance, based on the provided text:
Acceptance Criteria and Device Performance Study for syngo.CT Brain Hemorrhage
1. Table of Acceptance Criteria and Reported Device Performance
The document states a performance goal rather than strict acceptance criteria with defined thresholds. The acceptance was based on exceeding this goal.
| Performance Metric | Performance Goal (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Sensitivity | > 80% | 92.8% (95% CI: 89.3%-95.2%) |
| Specificity | > 80% | 94.5% (95% CI: 91.3%-96.5%) |
| Average Per-Case Processing Time | Comparable to predicate device | 13.67 seconds (95% CI: 7.48-19.86 seconds) |
2. Sample Size and Data Provenance
- Test Set Sample Size: 600 anonymized head CT cases.
- Data Provenance: The cases were collected from 5 sites in the US and Europe. The data was retrospective.
- Case Distribution: Approximately equal distribution of positive (cases with ICH) and negative (cases without ICH) cases.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: 3
- Qualifications: US board-certified neuroradiologists with more than 10 years of experience.
4. Adjudication Method for the Test Set
The ground truth was established by majority read of the 3 neuroradiologists. This implies a 2+1 adjudication, where if at least two experts agreed, that decision was taken as the truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The study described is a standalone performance study of the algorithm. Therefore, there is no information on how human readers improved with AI vs. without AI assistance. The device is intended solely for worklist prioritization and is not for diagnostic use or to alter images.
6. Standalone (Algorithm Only) Performance Study
Yes, a retrospective standalone performance study was conducted. The reported sensitivity and specificity values are for the algorithm only, without human-in-the-loop.
7. Type of Ground Truth Used
The ground truth was established by expert consensus (majority read of 3 US board-certified neuroradiologists).
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set. It only describes the validation (test) set.
9. How 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 only details how the ground truth for the test set was created (majority read by 3 neuroradiologists).
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