(233 days)
CAC (gated) is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above. The device automatically analyzes non-contrast electrocardiogram (ECG) gated cardiac computed tomography (CT) images collected and outputs the segmentation (intended for informational purposes only) and quantification of detected calcium.
The output of the subject device is made available to the physician on-demand as part of his or her standard workflow. The device-generated quantification can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium segmentation in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original cardiac CT scan; both are still available to be viewed and used at the discretion of the physician.
The device is intended to provide information to the physician to provide assistance during review of the patient's case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient's results.
Bunkerhill CAC (gated) is a software as a medical device (SaMD) product that interfaces with compatible and commercially available CT systems. Bunkerhill CAC (gated) localizes, quantifies, and categorizes coronary artery calcification in non-contrast, electrocardiogram (ECG) gated, chest CT studies. The core features of the product are:
- Categorization of the coronary artery calcium burden in the form of a range of Agatston scores. Calcium score groupings are defined as one of the four following ranges of Agatston units:
- a. Group 1: 0 Agatston units
- b. Group 2: 1-99 Agatston units
- Group 3: 100-399 Agatston units C.
- d. Group 4: 400+ Agatston units
- Quantification of the overall coronary artery calcium burden in the form of an exact Agatston Score.
- o Quantification of each coronary artery's (left main (LCA), left anterior descending (LAD), left circumflex (LCX), and right coronary artery (RCA)) calcium burden in the form of an exact Agatston score.
- Localization of estimated calcium burden in the form of a CAC segmentation applied to a copy of the original CT scan (intended for informational purposes only).
Acceptance Criteria and Study Details for BunkerHill Health's CAC (gated) Algorithm (K240369)
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cohen's weighted kappa for the 4-category score group assessment: At least 0.90 | Cohen's weighted kappa: 0.972 (95% CI 0.958, 0.987) |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The exact number of cases in the test set is not explicitly stated, but it included "adequate representation from each coronary calcium detection category."
- Data Provenance: Retrospective study involving gated CT studies from six (6) geographically diverse sites. The specific countries of origin are not mentioned.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications (e.g., years of experience as a radiologist). However, it mentions "established ground truth," implying expert review.
4. Adjudication Method for Test Set
The adjudication method used to establish the ground truth for the test set is not specified in the provided document.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was mentioned in the document. The study focused on the standalone performance of the AI algorithm against a ground truth.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The document states:
"The CAC (gated) Device performance was validated in a stand-alone retrospective study for overall agreement of the device output compared to the established ground truth."
7. Type of Ground Truth Used
The type of ground truth used was "ground truth coronary calcium detection category," which was established for each case in the test set. While not explicitly detailed, this typically implies a consensus among expert readers or a gold standard interpretation.
8. Sample Size for Training Set
The document does not provide information regarding the sample size used for the training set.
9. How Ground Truth for Training Set Was Established
The document does not specify how the ground truth for the training set was established.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.