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The Heartflow Analysis is an AI-based medical device software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for adult patients (ages 22 years and older) with suspected coronary artery disease. It provides anatomic data, plaque localization and characterization, as well as the calculations of FFRCT, a coronary physiological simulation, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. The Heartflow Analysis is intended to support the risk assessment and functional evaluation of coronary artery disease.

The Heartflow Analysis is provided to support qualified clinicians to aid in the evaluation and risk assessment of coronary artery disease. The Heartflow Analysis is 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.

The Heartflow Analysis is an AI-based medical device 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 in the risk stratification and evaluation of coronary artery disease.

The software displays coronary anatomy and functional information using graphics and text, including computed and derived quantities of percent stenosis, plaque volumes, blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease.

The Heartflow Analysis is performed on previously physician-acquired image data and is unrelated to acquisition equipment and clinical workstations.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) Clearance Letter for HeartFlow Analysis:

1. Table of Acceptance Criteria and Reported Device Performance:

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The HeartFlow Analysis is an AI-based medical device software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for patients with suspected coronary artery disease. It provides anatomic data, plaque identification and characterization, as well as the calculations of FFRCT, a coronary physiological simulation, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. The HeartFlow Analysis is intended to support the risk assessment and functional evaluation of coronary artery disease.

The HeartFlow Analysis is provided to support qualified clinicians to aid in the evaluation and risk assessment of coronary artery disease. The HeartFlow Analysis is 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.

The HeartFlow Analysis is an Al-based medical device 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 in the risk stratification and evaluation of coronary artery disease.

The software displays coronary and functional information using graphics and text, including computed and derived quantities of percent stenosis, plaque volumes, blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease.

The HeartFlow Analysis is performed on previously physician-acquired image data and is unrelated to acquisition equipment and clinical workstations.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria with numerical targets or thresholds. It generally discusses "validation studies including stress testing, and repeatability testing to ensure the safety and effectiveness of the device" and that "results concluded the device was acceptable for use."

However, based on the context of the device and its intended use, we can infer general performance areas. Since no specific acceptance criteria are given, the "Reported Device Performance" column will reflect the general conclusion from the document.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: The document states that testing and evaluation used "previously acquired diagnostic images received through HeartFlow sponsored clinical trials." However, a specific number for the test set sample size is not provided.
• Data Provenance: The data was "previously acquired diagnostic images received through HeartFlow sponsored clinical trials." This suggests the data is retrospective (already acquired) and likely originates from various clinical trial sites, but specific countries are not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1).

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

The provided text does not mention if an MRMC comparative effectiveness study was done, nor does it specify an effect size of human readers' improvement with AI vs. without AI assistance. The focus is on the device's standalone validation.

6. Standalone (Algorithm Only) Performance

Yes, a standalone (algorithm only) performance assessment was done. The document states:

• "The software was designed, developed, tested and validated according to written procedures."
• "Validation studies included stress testing, and repeatability testing to ensure the safety and effectiveness of the device."
• "Medical device design validation has been completed. Medical device design included testing and evaluation using previously acquired diagnostic images received through HeartFlow sponsored clinical trials."
• "Summaries of pre-clinical studies were reviewed as part of a prior predicate review (K161772, the original predicate of K182035/K190925/K203329). The results concluded the device was acceptable for use."

This indicates that the device's performance was evaluated independently without human intervention during the "testing and evaluation" phase described, proving its standalone capabilities.

7. Type of Ground Truth Used

The document implies that the ground truth was established through clinical diagnosis and evaluation of the "previously acquired diagnostic images" from HeartFlow-sponsored clinical trials. While it doesn't explicitly state "expert consensus," this is the most likely method for establishing ground truth in clinical trials concerning coronary artery disease diagnoses from images. No mention of pathology or outcomes data as direct ground truth is made in this specific excerpt for the validation studies mentioned.

8. Sample Size for the Training Set

The document states: "The core technology remains unchanged from the primary predicate and continues to be trained using deep learning (AI and machine learning) since 2015, to incorporate learnings from the volumes of CT data and studies."

However, a specific sample size for the training set is not provided. It only mentions "volumes of CT data and studies."

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

The document implies that the ground truth for the training set was established through "learnings from the volumes of CT data and studies." Similar to the test set, this would likely involve expert interpretation and analysis of the CT data used for training the deep learning algorithms, reflecting accepted clinical diagnoses and findings within those studies. No further details are given.

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The HeartFlow Analysis 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 the calculations of FFR-cf 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. The HeartFlow Analysis is intended to support the functional evaluation of coronary artery disease.

The HeartFlow Analysis is provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The HeartFlow Analysis is 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.

The HeartFlow Analysis is a coronary physiological 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 and treatment planning of coronary artery disease.

The HeartFlow Analysis is performed on previously physician-acquired image data and is unrelated to acquisition equipment and clinical workstations.

The provided document is a 510(k) summary for the HeartFlow Analysis (FFRct v3) device. It describes the device and claims substantial equivalence to a predicate device (HeartFlow FFRct v2.Planner, K190925). However, it does not contain the detailed acceptance criteria or the specific study results that directly prove the device meets said criteria for FFRct v3.

The document states: "Summaries of pre-clinical studies were reviewed as part of a prior predicate review (K161772, the predicate of K182035 that is the predicate of K190925). The results concluded the device was acceptable for use." This refers to studies for previous versions of the device, not specifically for "FFRCT v3" and its new solver.

The document claims: "Changes to flow and distribution calculations within the Gen3 solver do not raise new questions of safety and effectiveness." and "Results of all current and previously referenced testing conclude the device is acceptable for use." This implies that the new version is acceptable based on the previous version's validation studies and that the changes are not significant enough to warrant new clinical studies to prove effectiveness.

Therefore, many of the requested details, such as specific acceptance criteria for FFRct v3, reported device performance data, sample sizes, ground truth establishment for a new study, and multi-reader multi-case study results for this specific version, are not provided in this document.

Based only on the provided text, here's what can be extracted and what is missing or implied:

1. Table of acceptance criteria and the reported device performance:

   Acceptance Criteria

   Reported Device Performance (for FFRct v3)

   Not explicitly stated for FFRct v3 in this document. The document refers to prior predicate review studies (K161772) that concluded the device was acceptable for use, implying prior acceptance metrics were met by older versions.

   The document states: "Changes to flow and distribution calculations within the Gen3 solver do not raise new questions of safety and effectiveness." and "Results of all current and previously referenced testing conclude the device is acceptable for use." This implies that the performance of FFRct v3, with its Gen3 solver, is considered equivalent to and meets the same acceptable standards as its predicates, without providing new quantitative performance metrics for FFRct v3 itself.

2. Sample sizes used for the test set and the data provenance:

   • Test set sample size: Not specified for FFRct v3. The document refers to "previously acquired diagnostic images received through HeartFlow sponsored clinical trials" for earlier versions of the device.
   • Data provenance: Not specified for FFRct v3. For previous versions, it's implied the data came from "HeartFlow sponsored clinical trials," but country of origin or retrospective/prospective nature is not detailed for any specific version.

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

   • Not specified for FFRct v3. This information might be detailed in the "pre-clinical studies" mentioned for the predicate devices (K161772), but those details are not included in this summary.

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

   • Not specified for FFRct v3.

5. 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 for FFRct v3. The document mentions the device is intended "to support qualified clinicians to aid in the evaluation and assessment," but no MRMC study details or effect sizes are provided.

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

   • The core claim of the HeartFlow Analysis (FFRct) is to "compute FFRCT, a mathematically derived quantity." This inherently describes a standalone algorithmic function. However, the document also states, "Clinician review and assessment of analysis prior to use as supplemental diagnostic aid." This suggests the standalone performance is part of a human-in-the-loop clinical workflow, but results for standalone performance are not explicitly detailed.

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

   • Not specified for FFRct v3. For the underlying FFRCT technology, the ground truth for FFR (Fractional Flow Reserve) is typically invasive coronary angiography with pressure wire measurements. This is only implied from the known context of FFRct validity, but not explicitly stated in this document for the validation of FFRct v3.

8. The sample size for the training set:

   • Not specified for FFRct v3, or any previous versions addressed in this summary. The document mentions "Medical device design included testing and evaluation using previously acquired diagnostic images," which would likely include training data, but no specifics are given.

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

   • Not specified for FFRct v3, or any previous versions discussed in this summary.

In summary, the provided FDA 510(k) summary for HeartFlow Analysis (FFRct v3) primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and intended use. It does not provide specific new study data, acceptance criteria, sample sizes, or ground truth details for the current FFRct v3 version, instead referring to earlier predicate device reviews where such studies were reportedly conducted. The implication is that the changes in FFRct v3 (specifically the Gen3 solver) are not significant enough to require new comprehensive clinical validation studies to prove safety and effectiveness beyond what was already established for its predecessors.

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HeartFlow Analysis is a coronary physiologic simulation software for the clinical quantitative and ysis 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.

The HeartFlow Analysis is a coronary physiological simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOMcompliant 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 (diagnosis and treatment planning) of coronary artery disease.

HeartFlow FFR analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.

The new planner feature is also software, and uses as input the anatomic FFRct model, and an idealized model generated from the FFRct model. Just as a CFD solution is run on the anatomic FFRct model to get the color-coded FFRct Analysis, the planner feature runs a reduced order CFD solution for user selected combinations of the anatomic FFRct model and the idealized model.

Here's a breakdown of the HeartFlow Analysis device's acceptance criteria and the study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria for the device's performance. Instead, it focuses on demonstrating that the device's new "Planner" feature, which uses a reduced-order CFD solution for user-selected combinations of anatomic and idealized models, produces FFRct results equivalent to those achieved with the existing FFRct solver for a given modified anatomy.

Therefore, accepting this interpretation, here's a table based on the information provided:

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

The document does not specify the exact sample size used for the test set specifically for the Planner feature. It mentions "testing of various FFRct model modifications to represent a variety of vessel and lesion morphologies and their idealized state."

Regarding data provenance, the document states: "Summaries of pre-clinical studies were reviewed as part of a prior predicate review (K161772, the predicate to K182035). The results concluded the device was acceptable for use. The applicability of the clinical data is not effected by the changes proposed under the predicate K182035 nor this 510(k). No additional pre-clinical data is being provided with this submission." This indicates that previous clinical data was used, but details on country of origin or retrospective/prospective nature are not provided for the current submission's evaluation.

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set of the Planner feature. The assessment appears to be a technical comparison between the two CFD solvers rather than a clinical ground truth adjudicated by experts.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set, as the evaluation focuses on the technical equivalency of two computational solvers rather than subjective human assessment.

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

No MRMC comparative effectiveness study is mentioned for the current submission's evaluation of the Planner feature. The text highlights that "No additional pre-clinical data is being provided with this submission," suggesting the focus is on the technical changes rather than a new clinical trial.

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

Yes, a standalone evaluation was performed. The "design verification test (DVT)" focused on comparing the FFRct results produced by the Delta-solver (used by the "Planner" feature) with those from the FFRct solver (the existing algorithm) for a given modified anatomy. This is an algorithm-only comparison.

7. The Type of Ground Truth Used

For the evaluation of the Planner feature, the "ground truth" was effectively the output of the established FFRct solver for a modified anatomy. The goal was to demonstrate that the new "Delta-solver" within the Planner feature could produce equivalent results to this existing, validated computational model.

8. The Sample Size for the Training Set

The document does not provide information about the sample size of the training set.

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

The document does not provide information about how the ground truth for the training set was established. The submission focuses on the new feature of the HeartFlow Analysis software and references previous predicate reviews for the underlying FFRct technology.

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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 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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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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