(287 days)
The CardiOp-B System is a software system that assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on two to three 2D angiography images obtained from single plane angiography. CardiOp-B provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. CardiOp-B can also perform quantitative analysis of the left ventricle based on left ventricular angiograms. CardiOp-B is intended for use in real-time in the catheterization lab and off-line for post-procedural analysis. It is intended for use by clinicians, technicians and research personnel.
The CardiOp-B System is an image acquisition and processing software system designed as an add-on to conventional X-ray angiography systems. The CardiOp-B system improves the output of coronary angiography by presenting a three-dimensional reconstruction of the stenosed vessel as well as quantitative cross-section information. The LVA (Left Ventricular Analysis) package is an addition to the CardiOp-B System which is the subject of this Traditional 510(K).
1. Acceptance Criteria and Reported Device Performance
The CardiOp-B System, as described in the 510(k) summary, includes an LVA (Left Ventricular Analysis) package. The performance data section states: "Performance testing was performed to evaluate the modifications to the CardiOp-B system and produced accuracy and precision results within the predetermined specifications and comparable to results obtained by the marketed predicate devices."
While specific numerical acceptance criteria for the LVA package are not explicitly provided in the excerpt, the general criteria are implied to be accuracy and precision results within predetermined specifications and comparable to results obtained by predicate devices.
| Acceptance Criteria (Implied from text) | Reported Device Performance (Implied from text) |
|---|---|
| Accuracy within predetermined specifications | Achieved |
| Precision within predetermined specifications | Achieved |
| Comparable to predicate devices | Achieved |
2. Sample Size and Data Provenance for Test Set
The provided text does not specify the sample size used for the test set. It also does not explicitly state the country of origin of the data or whether the data was retrospective or prospective.
3. Number and Qualifications of Experts for Ground Truth
The provided text does not specify the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The provided text does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it provide an effect size for human reader improvement with or without AI assistance.
6. Standalone Performance Study
The information indicates that the CardiOp-B System is a "software system that assists in the evaluation of coronary lesions" and "provides quantitative information." While it performs quantitative analysis, the context suggests it's an assistive tool for clinicians, meaning a standalone (algorithm only) performance study might not be directly applicable in the same way as a diagnostic device replacing human interpretation. However, the performance testing described would assess the algorithm's standalone capabilities in terms of accuracy and precision of its measurements, but it's not explicitly framed as a standalone diagnostic performance study.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated. Given the device provides "quantitative information regarding the calculated dimensions of arterial segments based on the 3D image" and "quantitative analysis of the left ventricle based on left ventricular angiograms," the ground truth would likely involve highly accurate measurements from a gold standard method, potentially direct measurements from high-resolution imaging or another validated quantitative angiography method.
8. Sample Size for the Training Set
The provided text does not specify the sample size for the training set.
9. How Ground Truth for the Training Set was Established
The provided text does not specify how the ground truth for the training set was established.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.