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HeartFlow FFRCT is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRCT analysis is intended to support the functional evaluation of coronary artery disease.

The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of HeartFlow FFRCT 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 judgment.

FFRct v2.0 is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries.

The software displays the anatomy combined with function using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment of coronary artery disease.

Here is a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are presented as target rates for sensitivity and specificity, with achievement determined if the lower one-sided 95% confidence bound (LCL) exceeded the target rate.

Note: The definition for "Diseased" was: FFRCT ≤ 0.80 and FFR (reference standard) ≤ 0.80.

Additionally, a per-subject diagnostic performance analysis against the invasive FFR reference standard was provided, showing:

2. Sample Size Used for the Test Set and the Data Provenance

• Test Set Sample Size: The document implies the use of the "sequestered HeartFlowNXT dataset" for clinical validation of FFRct v2.0. While the exact number of patients or vessels in this specific sequestered dataset is not explicitly stated in this document, the original HEARTFLOW NXT study recruited 633 patients undergoing standard clinical care across 24 sites in the US, Europe, and Asia. It's reasonable to infer that the sequestered dataset for v2.0 validation was derived from this larger study.
• Data Provenance: The data was collected as part of the HeartFlowNXT study, which was a prospective, multicenter, non-randomized study. The participating sites included locations in the US, Europe, and Asia.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The ground truth for the test set was established using invasive Fractional Flow Reserve (FFR). Invasive FFR is a direct physiological measurement, and therefore, it does not typically involve interpretation by a panel of experts in the same way imaging ground truths sometimes do. The interpretation of FFR values (e.g., ≤ 0.80 indicating disease) is based on established clinical guidelines and not subjective expert consensus. The document does not specify the qualifications of the individuals who performed the invasive FFR procedures.

4. Adjudication Method for the Test Set

The ground truth was invasive FFR, which is an objective measurement. Therefore, no adjudication method (like 2+1 or 3+1 consensus) was needed for the ground truth itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Yes, a form of comparative effectiveness study was done. The document states:
"Per-subject FFRct specificity compared to site-read cCTA demonstrated superior diagnostic ability (p 50% stenosis severity for site-read cCTA."

• Effect Size (AI vs. without AI assistance):
  For "FFRCT ≤ 0.80":

  • Diagnostic Accuracy: 80.0% (74.4%-84.6%)
  • Sensitivity: 87.8% (78.5%-93.5%)
  • Specificity: 76.4% (69.3%-82.3%)

  For "SITE-READ CCTA > 50%":

  • Diagnostic Accuracy: 51.9% (45.5%-58.2%)
  • Sensitivity: 93.2% (85.1%-97.1%)
  • Specificity: 32.9% (26.1%-40.5%)

  Compared to site-read cCTA, FFRct demonstrates:

  • Significantly higher diagnostic accuracy (80.0% vs. 51.9%).
  • Much higher specificity (76.4% vs. 32.9%), indicating a substantial reduction in false positives.
  • Slightly lower sensitivity (87.8% vs. 93.2%), but the overall diagnostic ability is noted as superior for FFRct (p

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