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510(k) Data Aggregation
(265 days)
TeraRecon Cardiovascular.Calcification.CT is intended to provide an automatic 3D segmentation of calcified plaques within the coronary arteries and outputs a mask for calcium scoring systems to use for calculations. The results of TeraRecon Cardiovascular.Calcification.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care. TeraRecon Cardiovascular.Calcification.CT is a software as a medical device (SaMD) deployed as a containerized application. The device inputs are CT heart without contrast DICOM images. The device outputs are DICOM result files which may be viewed utilizing DICOM-compliant systems. The device does not alter the original input data and does not provide a diagnosis.
TeraRecon Cardiovascular.Calcification.CT is indicated to generate results from Calcium Score CT scans taken of adult patients, 30 years and older, except patients with pre-existing cardiac devices, electrodes, previous and established ischemic diseases (IMA, bypass grafts, stents, PTCA) and Thoracic metallic devices. The device is not specific to any gender, ethnic group, or clinical condition. The device's use should be limited to CT scans acquired on General Electric (GE) or Siemens Healthcare or their subsidiaries (e.g. GE Healthcare) equipment. Use of the device with CT scans from other manufacturers is not recommended.
The TeraRecon Cardiovascular.Calcification.CT algorithm is an image processing software device that can be deployed as a containerized application (e.g., Docker container) that runs on off-the-shelf hardware or on a cloud platform. The device provides an automatic 3D segmentation of the coronary calcifications.
When TeraRecon Cardiovascular.Calcification.CT results are used in external viewer devices such as TeraRecon's Intuition or Eureka Clinical AI medical devices, all the standard features offered by the external viewer are employed.
The TeraRecon Cardiovascular.Calcification.CT algorithm is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by individuals that have been trained in the software's function, capabilities, and limitations.
Here's a breakdown of the acceptance criteria and study details for the TeraRecon Cardiovascular.Calcification.CT device, based on the provided FDA 510(k) clearance letter:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Agatston Classification Accuracy: At least 80% accuracy for the 4 revised Agatston classes (0-10, 11-100, 101-400, >400), with a lower bound 95% confidence interval (CI) of at least 75%. | Passed. Mean accuracies exceeded 94% across Agatston categories, with 95% CI lower bounds above 75%. |
| Vessel Calcification Classification (Dice Similarity Coefficient): At least 80% DICE with a lower bound 95% confidence interval of at least 75% for segmentation of calcifications by vessel (LM, LAD, LCX, RCA). | Passed. Segmentation performance, measured by Dice similarity coefficient against expert annotations, consistently exceeded the predefined acceptance criteria (≥80% Dice with lower 95% CI ≥75%). |
Study Details
1. Sample Size Used for the Test Set:
The test set included 422 adult patients.
2. Data Provenance (Country of Origin, Retrospective/Prospective):
- Retrospective cohort study.
- At least 50% of the ground truth data is from the US, divided between multiple locations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- 3 annotators (experts) were used for each study to segment coronary vessels and apply thresholds to create calcification masks within the vessels.
- Qualifications of experts: Not explicitly stated in the provided text.
4. Adjudication Method for the Test Set:
- Majority vote (2+1 method): The final calcification ground truth for the calcification segmentation masks was attained if a voxel was part of at least 2 of the masks defined by the three annotators.
- For the ground truth vessel of calcification, it was also attained by majority vote among the 3 annotators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study involving human readers with and without AI assistance was mentioned. The study focused on standalone device performance against expert-established ground truth.
6. Standalone Performance:
- Yes, a standalone (algorithm only without human-in-the-loop performance) study was conducted. The results reported are directly attributed to the TeraRecon Cardiovascular.Calcification.CT device's performance against ground truth.
7. Type of Ground Truth Used:
- Expert consensus based on annotations from three experts. The experts segmented coronary vessels and applied thresholds to create calcification masks. The final ground truth was established by majority vote among these annotators for both the calcification mask and the vessel classification.
8. Sample Size for the Training Set:
- The document does not explicitly state the sample size used for the training set. It only describes the test set.
9. 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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