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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 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 functional information 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's a breakdown of the acceptance criteria and study information for the HeartFlow FFRct v 2.18 device, based on the provided text:

Acceptance Criteria and Device Performance (Based on K161772 Predicate, as no new data is presented for K182035):

Since the submitted K182035 explicitly states, "There is no change from the performance submitted as part of the predicate K161772" and "No additional pre-clinical or clinical data is being provided with this submission," the acceptance criteria and performance metrics are derived from the previous K161772 submission. The provided document itself does not detail the specific acceptance criteria or reported performance of the device in this text. It only states that the previous validation work for K161772 concluded the device was acceptable for use.

To fully answer this, the K161772 submission document would need to be reviewed. However, based solely on the provided text, we can infer that the device's acceptable performance was established in the prior submission.

Study Details (Inferred from reference to K161772):

The provided text for K182035 does not contain details of the study itself beyond confirming that "Software and medical device design validation was completed and reviewed as part of the predicate review (K161772)." Therefore, the following information is based on the implication that such studies were performed for the predicate device.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified in the provided text.
   • Data Provenance: The document states that HeartFlow FFRct "is independent of imaging equipment, imaging protocols and equipment vendors; the clinical validation report includes identification of vendors and equipment used in the clinical validation of the product." This implies a varied source, but specific countries or retrospective/prospective nature are not specified in the provided text.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified in the provided text. (For the predicate K161772, this would typically involve invasive FFR experts or interventional cardiologists.)

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not specified in the provided text.

4. 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:

   • Not specified in the provided text. The device's stated indication is to "support qualified clinicians to aid in the evaluation and assessment," which implies it's an assistive tool, but a formal MRMC comparative effectiveness study (human vs. human + AI) is not mentioned.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • The document describes FFRct as 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." This suggests the algorithm's performance in deriving FFRct values would be evaluated standalone against a ground truth (likely invasive FFR). The text also mentions "validation studies included stress testing, and repeatability testing to ensure the device performance," which would be standalone algorithm performance. However, specific standalone performance metrics (e.g., accuracy, concordance) and the study results are not detailed in the provided text. The indication for use, "to aid in the evaluation and assessment," also points to a standalone capability being critical before human integration.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not specified in the provided text. For FFRct, the gold standard for clinical validation is typically invasive Fractional Flow Reserve (FFR) measurements.

7. The sample size for the training set:

   • Not specified in the provided text.

8. How the ground truth for the training set was established:

   • Not specified in the provided text. (Presumably, this would also rely on invasive FFR data or similar clinically validated measurements.)

Summary of what is explicitly stated regarding studies for K182035:

• The current submission (K182035) does not include new pre-clinical or clinical data.
• The performance claims rely entirely on the validation performed for the predicate device, K161772.
• The K161772 submission included "Software and medical device design validation" and "Validation studies included stress testing, and repeatability testing to ensure the device performance."
• These previous studies "concluded the device was acceptable for use."

To get the specific details requested in points 1-9 for the HeartFlow FFRct device, one would need to consult the original K161772 510(k) submission and its supporting documentation. The provided text is a summary for a new submission that references the predicate's established performance without re-submitting or detailing the original study data.

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