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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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