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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 post-processing software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography (CT) 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 FFR-c 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 device is only for prescription use.

FFR v1.4 is post-processing image analysis software developed for the clinical quantitative and qualitative analysis of previously physician-acquired DICOM-compliant cardiac CT images and data, to assess the anatomy and function of the coronary arteries. The software displays the resulting coronary anatomy combined with functional information using graphics and text, including a computed and derived quantification of blood flow. termed FFR - to aid the clinician in the assessment of coronary artery disease.

The HeartFlow FFR cr software is housed at Heart Flow, Inc. The health care provider electronically sends the patient's CT scan data to HeartFlow. Inc. where a 3D computer model of the coronary arteries is developed and simulates blood flow in the models using computational fluid dynamics. A resulting report is electronically sent to the physician with the estimated fractional flow reserve (FFR) values (called FFRct values) displayed as color images of the patient's heart (Figure 1) and an associated color interpretation table (Table 1) indicating the error associated with each measurement range in the HFNXT clinical study.

Here's a breakdown of the acceptance criteria and the study detailing the device's performance:

Acceptance Criteria and Device Performance (HFNXT Study)

Note: The document states that the prespecified target goals identified by the sponsor for sensitivity and specificity were 65%, respectively. However, it also clarifies that these target goals were not agreed upon by the FDA. The table reflects the FDA's acceptance based on the reported lower one-sided 95% confidence bounds being "significantly above the pre-specified target goals of 65% and 55%, respectively, and were considered acceptable." This implies the FDA may have had slightly different internal thresholds but accepted these results.

Additional Per-Subject Diagnostic Performance (FFR_CT vs. Site-Read cCTA with FFR ≤ 0.80 as reference standard):

Study Details for HeartFlowNXT (HFNXT)

1. Sample Size used for the Test Set and Data Provenance:

   • Sample Size: 254 adult subjects comprise the intention-to-diagnose (ITD) population. In total, 484 vessels were analyzed for direct comparison of invasive FFR and FFR_CT.
   • Data Provenance: Prospective, multicenter, nonrandomized study conducted at 11 sites in 8 countries across Canada, Europe, and Asia. Data was collected from September 2012 to August 2013.

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

   • The document states that "All invasive FFR data was reviewed by an independent FFR/QCA core laboratory." The number of experts or their specific qualifications (e.g., years of experience, subspecialty) are not explicitly detailed in the provided text.

3. Adjudication Method for the test set:

   • The document implies a core lab review for invasive FFR data, suggesting a centralized and likely standardized method, but a specific "adjudication method" like 2+1 or 3+1 for discrepancies is not explicitly described for the final ground truth determination. The FFR_CT and cCTA data were interpreted in a blinded fashion, but the process for resolving disagreements or establishing the definitive FFR ground truth isn't detailed.

4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:

   • The HFNXT study compared the diagnostic performance of FFR_CT against cCTA alone. While it assesses the effectiveness of FFR_CT, it doesn't explicitly describe itself as a typical MRMC study designed to show how much human readers improve with AI vs. without AI assistance.
   • Effect Size with AI vs. without AI assistance: The study showed "Per-subject FFR_CT specificity compared to site-read cCTA demonstrated superior diagnostic ability (p

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