(251 days)
QANGIO XA 3D 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 QANGIO XA 3D 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.
QANGIO XA 3D is the Medis software solution for the quantitative analysis of cardiac X-ray Angiography (XA) studies. QANGIO XA 3D features:
- Acquisition guide and series selection guide
- Annotations and basic measurements
- 2D and 3D OCA vessel detection
- 2D and 3D OCA vessel quantification
- QFR calculations: Quantitative Flow Ratio (QFR) analysis with fixed flow model (fQFR) and contrast flow models (cQFR).
- Single vessel report
QANGIO XA 3D will be used by interventional cardiologists and researchers to obtain quantifications of lesions in coronary vessels, to determine the functional significance of the individual or consecutive multiple lesions, prior, during or after percutaneous coronary intervention treatment. QANGIO XA 3D has been developed as a standalone application to run on a Windows based operating system. The import of images and the export of analysis results are via CD / DVD, a PACS or network environment.
Here's a breakdown of the acceptance criteria and the study information for the QANGIO XA 3D, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state a table of acceptance criteria with numerical thresholds. Instead, it describes general validation approaches for its key functionalities.
| Functionality | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| 3D Vessel Reconstruction | Clinically validated accuracy and agreement with gold standard methods (e.g., IVUS pullbacks, QCA parameters). | Validated clinically in studies using QCA parameters and IVUS pullbacks in patients. |
| QFR Calculation (fQFR) | Accuracy and agreement with FFR values as a reference standard. | "The QFR value is validated against the FFR value in several validation studies." Examples cited: WIFI II, FAVOR II Europe-Japan, FAVOR II China, QFR and Non Culprit lesions in STEMI Patients. "Excellent results of true in-procedure QFR analyzed by end-users" in FAVOR II studies. "Estimates for precision of QFR are based on a strong body of evidence derived from multiple prospective studies." |
| QFR Calculation (cQFR vs. fQFR Agreement) | Demonstrated agreement between contrast flow model (cQFR) and fixed flow model (fQFR). | "The agreement between the fQFR and cQFR model has been shown in a comparative study." |
| Overall Software Functionality | All specified system requirements are met, as evidenced by successful testing and traceability between requirements and tests. No new potential hazards introduced. Safe and effective outcome. | "All functionality (including 3D vessel reconstruction and the calculation of the QFR pressure drop) is specified in the QANGIO XA 3D system requirements. All requirements are tested and all results of the tests performed are summarized in the software test statement and especially the requirements coverage matrix of QANGIO XA 3D proving traceability between requirements and tests successfully executed." "QANGIO XA 3D is a safe and effective medical device, and is at least as safe and effective as its predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- 3D Vessel Reconstruction: The text does not specify the sample size for the studies that validated 3D vessel reconstruction. It mentions "studies using QCA parameters and IVUS pullbacks in patients," implying patient data was used.
- QFR Calculation: Specifically for the prospective, observational, investigator-initiated multi-center studies for QFR vs. FFR (FAVOR II Europe-Japan and FAVOR II China), the text indicates:
- Sample Size: Not explicitly stated as a number. It refers to "prospective, observational, investigator-initiated multi-center studies."
- Data Provenance: Prospective and multi-center studies. The "FAVOR II Europe-Japan" and "FAVOR II China" study names directly indicate multiple countries (Europe and Japan for one, China for another). The nature is prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- For QFR Calculation (FAVOR II studies):
- Number of Experts: The text states, "QFR and FFR were analyzed separately by different observers." It does not specify the number of observers/experts involved in these studies.
- Qualifications of Experts: Not explicitly stated, but the context of "interventional cardiologists and researchers" using the device for "assessment of coronary vessels" in clinical settings, and "pressure-wire derived fractional flow reserve (FFR) as reference standard" implies that the observers for FFR (the ground truth) would be qualified cardiologists or specialists in cardiovascular intervention.
4. Adjudication Method for the Test Set
- The text states, "QFR and FFR were analyzed separately by different observers." This implies independent assessment rather than a specific adjudication method like 2+1 or 3+1 for discrepancies. The FFR value itself from the pressure wire is considered the reference standard, so its "ground truth" establishment isn't subject to expert consensus adjudication in the same way an image interpretation might be.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Yes, for QFR, the FAVOR II studies appear to fit the criteria of a multi-reader (different observers for QFR and FFR) multi-case (multiple patients/vessels) study comparing an AI-assisted measurement (QFR) against a reference standard (FFR).
- Effect Size of Human Readers Improve with AI vs. without AI assistance: This information is not provided. The studies focus on the agreement and diagnostic performance of QFR relative to FFR, not on how much human readers improve with AI assistance, as the QFR is presented as an alternative/comparative method to FFR for functional assessment. The QFR is derived from image analysis, which the device performs.
6. Standalone (Algorithm Only) Performance
- Yes, the performance data presented (e.g., QFR validation against FFR) reflects the standalone performance of the QANGIO XA 3D algorithm in generating QFR values from XA images. The device description emphasizes "QANGIO XA 3D is a standalone application." The QFR analysis is described as "calculated based on computer calculations."
7. Type of Ground Truth Used
- For 3D Vessel Reconstruction: "OCA parameters and IVUS pullbacks." Intravascular Ultrasound (IVUS) data is typically considered highly accurate and a robust reference standard for vessel dimensions and morphology, often involving pathology-level detail or direct physical measurement/imaging within the vessel.
- For QFR Calculation: "pressure-wire derived fractional flow reserve (FFR) as reference standard." FFR is a well-established and clinically accepted gold standard for assessing the hemodynamic significance of coronary artery stenoses, which is a form of physiological outcomes data or a highly validated physiological measurement.
8. Sample Size for the Training Set
- The text does not specify the sample size for the training set. It only refers to the validation studies. Since it's a 510(k) submission, the focus is on performance validation rather than detailed algorithm development specifics like training set size.
9. How the Ground Truth for the Training Set Was Established
- The text does not provide details on how the ground truth for the training set was established. It primarily discusses the validation of the system's outputs.
§ 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.