(444 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 Segments based on 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 offline 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 presents a three-dimensional reconstruction of the stenosed vessel as well as quantitative cross-section information. The system includes a software package that runs on off-the-shelf hardware. CardiOp-B's features and benefits include 3D reconstruction, real-time and quantitative measurements.
Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state quantitative acceptance criteria in the typical sense (e.g., "accuracy > X%"). Instead, the performance data describes the results in relation to pre-determined specifications and comparison to a predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accuracy & Precision (Phantom Data) | Within pre-determined specifications and comparable to currently marketed QCA systems. | Overall accuracy and precision results were within pre-determined specifications and comparable to those achieved with currently marketed QCA systems. |
| Correlation with Predicate QCA System (Clinical Images) | Demonstrated correlation between Minimal Lumen Diameter and Length results with an FDA-approved QCA system. | There is a correlation between the Minimal Lumen Diameter as well as Length results between the systems. |
| 3D Reconstruction Skeleton | Comparable to skeletons of 2D images in terms of spatial distribution. | The skeleton of the 3D reconstruction that is created by the system is comparable to the skeletons of 2D images of the vessel in terms of its spatial distribution. |
| Ability to Analyze Clinical Images | Able to analyze clinical images and provide diameter and length results. | The CardiOp-B system is able to analyze clinical images and provide diameter and length results that correlate to those of an FDA approved QCA system. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for either the phantom or clinical image validation.
- Data Provenance:
- Phantoms: The study used "phantoms," which are engineered objects designed to mimic biological structures for testing purposes. Their origin is not specified but is typically controlled laboratory settings.
- Clinical Images: "Clinical images" were used. The country of origin is not specified, and it's not explicitly stated whether the data was retrospective or prospective. Given the context of a 510(k) summary from 2003, it's more common for such data to be retrospective, but this is an inference.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set:
- Adjudication Method: Not specified. The document primarily refers to "comparison to those achieved with currently marketed QCA systems" for phantoms and "correlation... between the systems" for clinical images. This implies a comparative analysis rather than an explicit expert adjudication process against a distinct ground truth for the device's measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not described or indicated. The CardiOp-B system's evaluation was primarily focused on its own performance against phantoms and correlation with a predicate device, not on how it augmented human performance.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the described performance data appears to be for the standalone (algorithm-only) performance of the CardiOp-B System. The system "provides quantitative information," "analyzes 2-3 angiography images," and "creates a 3D image as well as quantitative data." The evaluation compares the system's output directly to phantom specifications and the predicate device's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Phantom Data: The ground truth was based on the known, engineered dimensions of the phantoms, which serve as a gold standard for accuracy and precision measurements in a controlled environment.
- For Clinical Data: The "ground truth" was effectively established by the measurements from the predicate QCA-CMS system. The study sought to demonstrate correlation with this established device, implying the predicate device's measurements served as a reference for comparison, rather than an independent "expert consensus" or "pathology" ground truth for the clinical cases themselves.
8. The sample size for the training set:
- Training Set Sample Size: Not specified. The document focuses exclusively on performance data and validation, with no mention of training data or how the model was developed (e.g., machine learning approaches).
9. How the ground truth for the training set was established:
- Training Set Ground Truth: Not specified, as there is no information provided about a training set or its ground truth.
§ 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.