(26 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 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 modifications to the CardiOp-B System which are the subject of this Special 510(K) include: Bifurcation and side-branch analysis
The Paieon CardiOp-B System, a 3D Vessel Analysis System, received 510(k) clearance (K072591) based on its substantial equivalence to predicate devices. The system is designed to create 3D images of coronary vessel segments from 2D angiography images and provide quantitative information about arterial dimensions.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or a detailed performance table from a clinical study. Instead, it mentions that "Applicable performance testing was performed to evaluate the modifications to the CardiOp-B system," which included "software validation and phantom performance evaluation." The "test results were found to be acceptable as required by the respective test plans and protocols, demonstrating that the modified device performs according to its specifications." Without specific criteria, it's impossible to populate a table with acceptance criteria and their corresponding reported values.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "phantom performance evaluation." This suggests that the test set likely consisted of images from phantoms (simulated anatomical structures), rather than human patient data. No specific sample size is provided for this phantom test set. Data provenance is not explicitly stated beyond "phantom performance evaluation," which implies controlled, synthetic data rather than retrospective or prospective human clinical data. The country of origin for the data is not specified.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
The document does not provide information on the number of experts used to establish ground truth or their qualifications. Given that the testing involved "phantom performance evaluation," the ground truth likely came from the known, precisely manufactured dimensions of the phantoms, rather than expert consensus on medical images.
4. Adjudication Method for the Test Set:
No adjudication method is described. For phantom studies, adjudication by human experts is typically not necessary as the "ground truth" is inherent in the design specifications of the phantom.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned, nor is there any information about the effect size of human readers improving with or without AI assistance. The study described focuses on the device's inherent performance rather than its impact on human reader performance.
6. Standalone Performance Study (Algorithm Only):
Yes, a standalone performance evaluation was conducted. The document states, "Applicable performance testing was performed to evaluate the modifications to the CardiOp-B system. Testing included software validation and phantom performance evaluation." This indicates that the device's algorithms were tested independently, likely by comparing its measurements against the known dimensions of the phantoms.
7. Type of Ground Truth Used:
The ground truth used was based on the known dimensions of phantoms. The phrase "phantom performance evaluation" strongly suggests that precisely engineered phantoms were used, where the true dimensions of the vessels/stenoses are known by design.
8. Sample Size for the Training Set:
The document does not provide any information regarding the sample size of a training set. This suggests that the device's underlying algorithms may not have been developed using a supervised learning approach requiring a labeled training set, or that information was not deemed necessary for a Special 510(k) submission focused on modifications.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned, information on how its ground truth was established is not provided.
§ 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.