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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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