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CathWorks FFRangio™ is a software device for the clinical quantitative and qualitative analysis of previously acquired angiography DICOM data for patients with coronary artery disease. It provides FFRangio™, a mathematically derived quantity, computed from simulated blood flow information obtained from a 3D computer model, generated from coronary angiography images. FFRangio™ analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided as a supportive aid for qualified clinicians in the evaluation and assessment of coronary arteries physiology. The results of CathWorks FFRangio™ are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional evaluation.

The FFRangio™ system is a computer system installed on a mobile cart that is to be located inside the catheterization room or in an adjacent technical/viewing area. The cart holds the computer processing unit, user interface control station (LCD screen and keyboard/mouse), medical isolation transformer, and network isolator. Operation requires only connections to mains and a DICOM communication port. The system supports optional visual media output to the Cath Lab main displays, so the system GUI may be observed on both the system's LCD display and on the Cath Lab's main display (boom monitor).

FFRancio™ uses standard angiographic images (angiograms) that are retrieved from the X-ray Imaging System (C-arm) in DICOM format. The user selects the images and, following the system prompts, marks key features on the images including the target lesion, ostium location, main vessel, target vessel, and its side branches. The system then matches the corresponding vessels among the projections and generates a 3D computer model of the vessels. The 3D model is used for blood flow analysis and determination of the FFRangio.

Here's a breakdown of the acceptance criteria and study details for the CathWorks FFRangio™ system, based on the provided text:

Acceptance Criteria and Device Performance

Notes:

• The reported performance for Sensitivity and Specificity includes the lower one-sided 95% confidence interval, which was used to determine if the device met the pre-specified target goals. Both were significantly above the targets.
• The correlation coefficient, intercept, and slope were secondary endpoints, and their direct "performance goals" are stated along with the achieved values.

Study Information

The primary study referenced is the FAST-FFR Trial.

2. Sample Size and Data Provenance:

• Test Set (Efficacy Analysis): 301 adult subjects and 319 coronary lesions.
• Study Enrollment: 382 subjects (30 roll-in, 352 study subjects).
• Data Provenance: Prospective, multicenter, international trial conducted at 10 sites in 5 countries: United States, Europe, and Israel.
  • 124 subjects (32.5%) were enrolled at sites in the United States.

3. Number and Qualifications of Experts for Test Set Ground Truth:

The document does not explicitly state the number of experts or their specific qualifications (e.g., years of experience) for establishing the ground truth of the invasive FFR. However, it does state:

• "All invasive FFR data were reviewed post-hoc by an independent FFR physiology core laboratory."

4. Adjudication Method for Test Set:

The document does not explicitly describe an adjudication method like 2+1 or 3+1 for the test set's ground truth by the independent FFR physiology core laboratory. It simply states that the data was "reviewed."

Furthermore, it states for the FFRangio™ data:

• "all FFRangio™ data were reviewed post-hoc by a core laboratory at CathWorks."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers with and without AI assistance was not explicitly mentioned or presented in the provided text. The study primarily focused on the standalone diagnostic accuracy of the FFRangio™ system compared to invasive FFR.

6. Standalone (Algorithm Only) Performance:

• Yes, a standalone performance study was conducted. The FAST-FFR trial specifically evaluated the FFRangio™ system's accuracy as compared to invasive wire FFR, with on-site hospital users blinded to the invasive FFR and the FFRangio™ not being used for diagnostic or clinical decisions. This demonstrates the algorithm's performance independent of real-time human-in-the-loop influence on clinical decisions.

7. Type of Ground Truth Used:

• Invasive Wire FFR: The ground truth for the test set was obtained from "invasive wire FFR" measured using a coronary pressure wire and hyperemic stimulus. This is considered the gold standard for FFR measurement.

8. Sample Size for the Training Set:

• The document does not explicitly state the sample size for the training set used to develop the FFRangio™ algorithm. It mentions two clinical studies:
  • A two-phase validation study using an "earlier version of the operator interface but the same image processing and computation algorithms as the final device." This study analyzed "203 coronary lesions" and demonstrated sensitivity, specificity, and diagnostic accuracy. While this study helped validate the algorithms, it's not explicitly labeled as the training set.
  • The FAST-FFR trial (the pivotal study), which serves as the test set.

9. How the Ground Truth for the Training Set Was Established:

• Similar to the training set size, the document does not explicitly detail how the ground truth for an independent training set was established.
  • The "two-phase validation study" mentioned in point 8, which used an earlier version of the algorithm, compared FFRangio™ to "invasive FFR obtained from patients already scheduled for coronary assessment in the cath lab." This suggests invasive FFR was used as ground truth for that prior validation, which likely informed the development and refinement of the final algorithm's "image processing and computation algorithms." However, a specific training set and its ground truth acquisition are not explicitly isolated in the provided text.

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