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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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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<0.001) in the intent to diagnose (ITD) subjects in one or more major epicardial coronary artery segments, using invasive FFR as the reference standard and defining hemodynamically-significant obstruction of a coronary artery (positive result) as an FFR ≤ 0.80 for both FFR and as > 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<0.001).

This indicates that AI assistance (FFRct) significantly improves the diagnostic ability compared to standard cCTA interpretation by human readers alone, primarily by drastically improving specificity.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The provided metrics for FFRct (sensitivity, specificity, accuracy) represent the standalone performance of the algorithm in determining hemodynamically significant obstruction based on the FFRct value ≤ 0.80, without direct human interpretation of the FFRct results being factored into these specific performance numbers for the device itself. The device serves to provide this FFRct value, and its performance is evaluated based on how well this value correlates with invasive FFR. While intended for clinicians to use, the reported metrics reflect the algorithmic output's accuracy.

7. The Type of Ground Truth Used

The ground truth for both per-vessel and per-subject analyses was invasive Fractional Flow Reserve (FFR), with a value of ≤ 0.80 indicating hemodynamically significant obstruction (disease). Invasive FFR is considered an objective physiological measurement.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It mentions that FFRct v2.0 was "clinically validated using the sequestered HeartFlowNXT dataset." This implies that while the validation dataset was sequestered from HeartFlowNXT, the training of the algorithm may have utilized other data, or a different portion of the HeartFlowNXT data not used for final validation. Information about the training set size or composition is not present in this summary.

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

The document does not provide details on how the ground truth for the training set was established. However, given that the validation ground truth was invasive FFR, it is highly probable that similar objective invasive FFR measurements were used to establish the ground truth for any training data utilized by HeartFlow to develop the FFRct algorithm.

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HeartFlow FFRCT is a post-processing 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 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.

FFRc v2.0 is post-processing image analysis 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.

The HeartFlow FFRct v2.0 device is a post-processing software that uses previously acquired Computed Tomography DICOM data to provide FFRct (Fractional Flow Reserve derived from CT), a mathematically derived quantity from simulated pressure, velocity, and blood flow information. This analysis supports the functional evaluation of coronary artery disease in clinically stable symptomatic patients.

The device's performance was evaluated in two main clinical studies: HeartFlowNXT and FFRct v2.0 Clinical Validation. The FFRct v2.0 Clinical Validation re-processed the sequestered HeartFlowNXT data with the updated software version to demonstrate equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HeartFlow FFRct v2.0 device were pre-specified target goals for per-vessel sensitivity and specificity, defined by the lower one-sided 95% Confidence Interval (LCL) being above the target rate.

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

The test set for the FFRct v2.0 Clinical Validation study used the same data as the HeartFlowNXT study.

• Sample Size: 254 adult subjects, resulting in 484 vessels for direct comparison of invasive FFR and FFRct.
• Data Provenance: Prospective, multicenter study conducted at 11 sites in 8 countries across Canada, Europe, and Asia.

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

• Number of Experts: Not explicitly stated, however, the text mentions that "All invasive FFR data was reviewed by an independent FFR/QCA core laboratory." This implies a group of qualified experts, but their specific number or individual qualifications are not detailed.
• Qualifications of Experts: The core laboratory specialized in FFR and Quantitative Coronary Angiography (QCA), indicating expertise in these areas.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly detailed. However, the mention of an "independent FFR/QCA core laboratory" reviewing all invasive FFR data suggests a standardized and likely adjudicated process for determining the ground truth, rather than relying on individual site interpretations.

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

• MRMC Study: The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving human readers. Instead, it compares the performance of FFRct to site-read cCTA (which implicitly involves human interpretation) in a standalone manner against the FFR reference standard.
• Effect Size of Human Readers' Improvement with AI: Since no MRMC study with AI assistance vs. without AI assistance for human readers was reported, an effect size of human reader improvement with AI cannot be determined from this document. The comparison is between FFRct performance and initial cCTA interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Study: Yes, a standalone performance evaluation of the FFRct v2.0 algorithm was done. The study assessed the FFRct v2.0's ability to identify hemodynamically significant obstructions (FFR ≤ 0.80) directly against the invasive FFR reference standard, without human-in-the-loop interpretation of the FFRct results. The reported sensitivity and specificity values are for the algorithm's output.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was invasive fractional flow reserve (FFR) measurements, with a threshold of ≤ 0.80 indicating a hemodynamically significant obstruction. This is considered the standard of care in-vivo measurement in humans for determining the hemodynamic significance of coronary lesions.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document states that HeartFlow conducted three primary clinical studies for validation. The HeartFlowNXT study provided the clinical validation for the predicate device, FFRct v1.4. The FFRct v2.0 (the device in question) "was clinically validated using the sequestered HeartFlowNXT dataset to evidence equivalence." This implies that the HeartFlowNXT dataset was used as a validation set for FFRct v2.0, rather than a training set. The size of any explicit training set prior to this validation is not specified in the document.

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

• Ground Truth for Training Set: As the document refers to the HeartFlowNXT dataset as a validation set for FFRct v2.0, it doesn't describe the establishment of ground truth for a distinct training set for v2.0.
  • For the HeartFlowNXT dataset itself (which served as the basis for predicate validation and v2.0 validation), the ground truth was "direct measurement of FFR (≤0.80) during cardiac catheterization". All invasive FFR data was reviewed by an independent FFR/QCA core laboratory. If any part of the HeartFlowNXT data was used for training or development of v2.0 (before final "sequestering" for validation), the ground truth would have been established the same way.

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