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510(k) Data Aggregation
(85 days)
CINA is a radiological computer aided triage and notification software indicated for use in the analysis of (1) non-enhanced head CT images and (2) CT angiographies of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) CT angiographies of the head for large vessel occlusion (LVO).
CINA uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) LVO on a standalone Web application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings. 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 diagnostic device.
The results of CINA 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.
CINA is a radiological computer-assisted triage and notification software device.
The software system is based on algorithm-programmed components and is comprised of a standard off-the-shelf operating system and additional image processing applications.
DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspicious results of an intracranial hemorrhage (ICH) or a large vessel occlusion (LVO), then notifications on the flagged series are sent to the Worklist Application.
The Worklist Application (on premise) displays the pop-up notifications of new studies with suspected findings when they come in, and provides both active and passive notifications. Active notifications are in the form of a small pop-up containing patient name, accession number and the type of suspected findings (ICH or LVO). All the non-enhanced head CT images and head CT angiographies studies received by CINA device are displayed in the worklist and those on which the algorithms have detected a suspected finding (ICH or LVO) are marked with an icon (i.e., passive notification). In addition, a compressed, small black and white image that is marked "not for diagnostic use" is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the radiologist with notification facilitates earlier triage by allowing one to prioritize images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.
Here's a breakdown of the acceptance criteria and study details for the CINA device, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the performance goals for sensitivity and specificity. The reported performance for CINA met or exceeded these goals and was comparable to or better than the predicate/reference devices.
Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implied Performance Goal) | Reported Device Performance (CINA) | Comparison to Predicate/Reference |
|---|---|---|---|
| ICH Triage Application | |||
| Sensitivity | ≥ 80% | 91.4% (95% CI: 87.2% – 94.5%) | Similar to BriefCase (93.6%) |
| Specificity | ≥ 80% | 97.5% (95% CI: 95.8% – 98.6%) | Similar to BriefCase (92.3%) |
| AUC | N/A | 0.94 | N/A |
| Time-to-notification | Efficient, comparable to predicate (e.g., < 4.46 min) | 21.6 ± 4.4 seconds | Substantially equivalent/faster than BriefCase (4.46 minutes) |
| Overall Agreement (Accuracy) | N/A | 95.6% | N/A |
| LVO Triage Application | |||
| Sensitivity | ≥ 80% | 97.9% (95% CI: 94.6% - 99.4%) | Better than ContaCT (87.8%) |
| Specificity | ≥ 80% | 97.6% (95% CI: 95.1% - 99%) | Better than ContaCT (89.6%) |
| AUC | N/A | 0.98 | N/A |
| Time-to-notification | Efficient, comparable to reference (e.g., < 7.32 min) | 34.7 ± 10.7 seconds | Substantially equivalent/faster than ContaCT (7.32 minutes) |
| Overall Agreement (Accuracy) | N/A | 97.7% | N/A |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- ICH: 814 clinical anonymized cases
- LVO: 476 clinical anonymized cases
- Data Provenance: Retrospective, multicenter, multinational. The data was provided from 3 clinical sources (2 US and 1 OUS - Outside US).
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Three US-board-certified neuroradiologist readers.
- Qualifications: US-board-certified neuroradiologist readers. (No specific years of experience are mentioned, but board certification implies a high level of expertise).
4. Adjudication Method
The ground truth was established by concurrence of the three US-board-certified neuroradiologist readers. This implies a 3-reader consensus method (e.g., 3-reader agreement required), though the specific workflow (e.g., if disagreements were resolved) is not explicitly detailed beyond "concurrence."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication of a multi-reader multi-case (MRMC) comparative effectiveness study being performed that evaluates the improvement of human readers with AI vs. without AI assistance. The study focuses on the standalone performance of the AI algorithm.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done.
The document explicitly states:
- "Avicenna.Al conducted a retrospective, blinded, multicenter, multinational study with the CINA software with the primary endpoint to evaluate the software's performance..." (page 6)
- "The results of the standalone assessment study demonstrated an overall agreement (accuracy) of 95.6% and 97.7% for the 'ICH' and 'LVO' tested cases, respectively, when compared to the ground truth (operators' visual assessments)." (page 7)
7. Type of Ground Truth Used
The ground truth was established by expert consensus (concurrence of three US-board-certified neuroradiologist readers).
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set. It only describes the test set.
9. How Ground Truth for Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. It only describes the establishment of ground truth for the test set.
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