(239 days)
AccuFFRangio is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease.
When the quantified results provided by AccuFFRangio are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.
ArteryFlow® AccuFFRangio is designed as a stand-alone software package to run on a PC. This software can read traditional x-ray angiographic images with DICOM format from the local file directory.
The AccuFFRangio is composed of the following analysis workflows: Image Loading, Frame Selection, Vessel Reconstruction, QCA Vessel Quantification, and AccuFFRangio Calculation for visualization of the target coronary segment, quantification of the stenosis and pressure drop of the coronary seqment. The AccuFFRangio parameter is only for quantitative imaging output but not for diagnosis and the AccuFFRanigo product has a moderate level of concern.
The user can calculate the pressure drop and AccuFFRangio (FFR) value for the coronary vessel. To obtain these values for a specific lesion in a coronary vessel, the user has to start with Frame Selection using two angiographic images from different views. In each of these images, a classic 2D coronary contour detection is performed, after which a reconstruction of the coronary segment is obtained in 3D space. Based on the 3D reconstruction and user input of the aortic pressure, the pressure drop and AccuFFRangio value can be calculated.
AccuFFRangio enables interventional cardiologists to obtain accurate anatomical quantifications of one or more lesions in the analyzed coronary segment, and to assess the best viewing angles which can be helpful for optimal visualization of the lesion during percutaneous coronary intervention (PCI) treatment.
Results can be displayed and generated by the software, which contains patient information, imaging of actual and reference vessel boundaries, dimensions of the vessel sizing, pressure drop, and AccuFFRangio value. The results can be export in PDF format. This functionality is independent of the type of vendor acquisition equipment.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 3D Vessel Reconstruction | Lesion Length Accuracy | Demonstrated similar performance compared to the predicate device QAngio XA 3D (K182611). |
| Diameter Stenosis Accuracy | Demonstrated similar performance compared to the predicate device QAngio XA 3D (K182611). | |
| Area Stenosis Accuracy | Demonstrated similar performance compared to the predicate device QAngio XA 3D (K182611). | |
| Minimal Lumen Diameter Accuracy | Demonstrated similar performance compared to the predicate device QAngio XA 3D (K182611). | |
| Reference Diameter Accuracy | Demonstrated similar performance compared to the predicate device QAngio XA 3D (K182611). | |
| AccuFFRangio Calculation | Accuracy (for pressure drop and AccuFFRangio) | Demonstrated similar performance compared to the QFR by the predicate device QAngio XA 3D (K182611). |
| Sensitivity (for pressure drop and AccuFFRangio) | Demonstrated similar performance compared to the QFR by the predicate device QAngio XA 3D (K182611). | |
| Specificity (for pressure drop and AccuFFRangio) | Demonstrated similar performance compared to the QFR by the predicate device QAngio XA 3D (K182611). | |
| Positive Predictive Value (for pressure drop and AccuFFRangio) | Demonstrated similar performance compared to the QFR by the predicate device QAngio XA 3D (K182611). | |
| Negative Predictive Value (for pressure drop and AccuFFRangio) | Demonstrated similar performance compared to the QFR by the predicate device QAngio XA 3D (K182611). |
Study Details for Acceptance Criteria Proof:
-
Sample size used for the test set and the data provenance:
- 3D Vessel Reconstruction: "A phantom study had been implemented by using three different types stenosis of brass model." The specific number of images or cases analyzed in this phantom study is not provided.
- AccuFFRangio calculation: "a series of X-ray angiographic dataset with known pressure drops were analyzed." The specific number of cases or images in this dataset is not provided.
- Data Provenance: Not explicitly stated for either study (e.g., country of origin, retrospective/prospective). The phantom study suggests a controlled laboratory environment rather than patient data. The AccuFFRangio Calculation refers to an "X-ray angiographic dataset," implying patient data, but details are missing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of human experts to establish ground truth for the test sets in either the 3D vessel reconstruction or AccuFFRangio calculation studies.
- For the 3D vessel reconstruction, the ground truth was based on "three different types stenosis of brass model," implying a physical model with known dimensions.
- For the AccuFFRangio calculation, the ground truth was established by "X-ray angiographic dataset with known pressure drops." The method by which these "known pressure drops" were determined (e.g., invasive FFR measurements, expert consensus using other clinical data) is not specified, and therefore, the involvement or qualifications of experts are not described.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. The studies described do not involve human review for ground truth with an adjudication process.
-
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:
- No MRMC comparative effectiveness study is described in the provided text. The studies focus on the standalone performance of the device compared to a predicate device or known physical/physiological values.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the studies described are standalone performance evaluations of the AccuFFRangio software. The text explicitly states that "AccuFFRangio is designed as a stand-alone software package." The performance data section describes evaluating the software's output directly against phantom measurements or known physiological values.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- 3D Vessel Reconstruction: Physical phantom measurements (brass models).
- AccuFFRangio calculation: "Known pressure drops" from an X-ray angiographic dataset. The origin or method of determining these "known pressure drops" is not detailed, so it's not explicitly stated as expert consensus, invasive FFR, or outcomes data.
-
The sample size for the training set:
- The document does not provide information about the sample size used for the training set of the AccuFFRangio device. The performance data section focuses solely on validation/testing.
-
How the ground truth for the training set was established:
- As training set details are not provided, how its ground truth was established is also not described in the document.
§ 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.