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HeartSee version 4 software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in ml/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images and quantification of their severity.

HeartSee version 4 is intended for use by trained professionals, such as nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification. The climician remains ultimately responsible for the final assessment and diagnosis based on standard practices, clinical judgment and interpretation of PET images or quantitative data.

HeartSee version 4 is a software tool for cardiac positron emission tomography (PET) for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map for facilitating the interpretation of PET perfusion images in patients with suspected or known coronary artery disease. HeartSee version 4 is intended for use by trained professionals, such as nuclear technicians, nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification.

HeartSee version 4 contains two fundamental components. First, the software imports cardiac PET images in DICOM format from PET scanners with DICOM output. These images are reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. Second, the HeartSee version 4 software quantifies regional absolute rest and stress myocardial perfusion per unit tissue (ml/min/g), Coronary Flow Reserve (CFR) as the stress/rest perfusion ratio, and the Coronary Flow Capacity combining CFR and stress perfusion, all on a pixel basis for regional and global values. HeartSee version 3 (K202679) and version 4 also display stress subendocardial to subepicardial ratio, subendocardial stress to rest ratio on relative activity tomograms and stress relative topogram maps expressed as a fraction of maximum ml/min/g, called relative stress flow (RSF). Archiving output data is supported for clinical diagnostics, quality control and research.

In addition to these established measurements of perfusion in ml/min/g. CFR and CFC approved by FDA for K202679, HeartSee version 4 has software for determining left ventricular ejection fraction (EF) by PET-CT using Rb-82 compared to EF by the precedent FDA approved Emory Cardiac Toolbox version V4.1.7786.35544.

The provided document is a 510(k) premarket notification decision letter from the FDA regarding the "Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4". While it describes the device, its indications for use, and a summary of performance data comparing it to predicate devices, it does not contain a detailed study report with specific acceptance criteria and a structured study design to prove those criteria are met.

The document states that "Data also shows that HeartSee measurement of LVEF by PET-CT using Rb-82 provides an accurate, robust measure of LVEF that is comparable to Emory Toolbox for PET-CT EF approved by FDA," and mentions analysis methods like "Cox multivariate analysis and Kaplan-Meier plots" and "ROC analysis and paired t-tests." However, it does not provide the specific numerical acceptance criteria, the detailed methodology of the study (e.g., sample size, ground truth establishment, expert qualifications, adjudication), or the exact results against the criteria.

Therefore, I cannot populate all the requested information from the provided text. I will extract what is available and indicate where information is missing.

Acceptance Criteria and Device Performance (Inferred/Missing)

Study Details:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document implies the data was used to demonstrate equivalence and performance but doesn't detail the study cohort.

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

   • Not specified. The document mentions "trained professionals, such as nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification" for the intended users, but doesn't detail their role in ground truth establishment for this specific study.

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

   • Not specified.

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:

   • No MRMC study evaluating human reader improvement with AI assistance is explicitly described. The comparison is primarily between the HeartSee software (including its LVEF calculation) and predicate devices/established clinical findings. The software is described as assisting clinical interpretation and quantification, but direct human reader performance improvement is not detailed.

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

   • The document implies standalone performance was assessed for LVEF comparability ("HeartSee measurement of LVEF... provides an accurate, robust measure... comparable to Emory Toolbox"). The assessments of CFR, stress perfusion, and various ratios ("by Cox multivariate analysis and Kaplan-Meier plots," "By ROC analysis and paired t-tests") also suggest a focus on the algorithm's direct quantitative output rather than human interpretation.

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

   • For LVEF: Comparator with "Emory Toolbox for PET-CT EF approved by FDA" served as a reference. This acts as a form of established clinical measurement/reference standard.
   • For CFR and stress perfusion: Clinical outcomes data (mortality, major adverse coronary events (MACE), revascularization) served as the "ground truth" or clinical endpoint for association analysis.
   • For ratios (subendo/subepicardial, stress/rest, RSF): Clinical findings of "angina or ST depression ≥1mm during stress PET" served as the "ground truth" or clinical endpoint for association.

7. The sample size for the training set:

   • Not specified. The document refers to "Data also shows..." and "By Cox multivariate analysis..." but does not delineate training vs. test sets or their sizes.

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

   • Not specified. Assuming a similar approach to the test set, it would likely involve established clinical measurements, outcomes data, or clinical findings.

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HeartSee version 3 software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in ml/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images and quantification of their severity.

HeartSee version 3 is intended for use by trained professionals, such as nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification. The clinician remains ultimately responsible for the final assessment and diagnosis based on standard practices, clinical judgment and interpretation of PET images or quantitative data.

HeartSee version 3 is a software tool for cardiac positron emission tomography (PET) for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map for facilitating the interpretation of PET perfusion images in patients with suspected or known coronary artery disease. HeartSee version 3 is intended for use by trained professionals, such as nuclear technicians, nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification.

HeartSee version 3 contains two fundamental components. First, the software imports cardiac PET images in DICOM format from PET scanners with DICOM output. These images are reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. Second, the HeartSee version 3 software quantifies regional absolute rest and stress myocardial perfusion per unit tissue (ml/min/q), Coronary Flow Reserve (CFR) as the stress/rest perfusion ratio, and the Coronary Flow Capacity combining CFR and stress perfusion, all on a pixel basis for regional and global values, Archiving output data is supported for clinical diagnostics, quality control and research.

In addition to these established measurements of perfusion in ml/min/g, CFR and CFC approved by FDA for K171303, HeartSee version 3 has the following additional clinically relevant displays. For explaining uncommon patients with angina or ST depression ≥1mm during stress PET imaging in the absence of severe perfusion defects, HeartSee version 3 has the following three additional displays:

• 1. Stress subendocardial to subepicardial ratio on relative activity tomograms.
• 2. Subendocardial stress to rest ratio on relative activity tomograms
• 3. Stress relative topogram maps expressed as a fraction of maximum ml/min/g and called relative stress flow (RSF).

This K202679 submission describes the HeartSee version 3 software, which is an update to the previously cleared HeartSee version 2 (K171303). The new version adds three new displays. The performance data presented focuses on demonstrating that HeartSee version 3 is at least as safe and effective as its predicate device and that the new displays provide additional clinical relevance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state formal acceptance criteria in numerical values for this 510(k). Instead, it relies on demonstrating equivalence to the predicate device for existing functionalities and clinical relevance for the new functionalities. The performance is reported in terms of statistical associations.

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

The document does not explicitly state the sample size for the test set. It mentions "patients with suspected or known coronary artery disease (CAD)" and "uncommon patients with angina or ST depression ≥1mm during stress PET imaging".

The data provenance is not specified in terms of country of origin. The study appears to be retrospective as it analyzes associations with past clinical events (MACE, mortality) and existing patient characteristics (angina, ST depression).

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

The document does not provide information regarding the number of experts or their qualifications for establishing ground truth for any test set or for interpreting the data used in the analysis.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described or presented in this document. The study focuses on the algorithm's performance in terms of statistical associations rather than human reader improvement with or without AI assistance.

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

Yes, the performance data presented is for the standalone algorithm. The analyses performed (Cox multivariate analysis, Kaplan-Meier plots, ROC analysis, paired t-tests) evaluate the metrics generated by the HeartSee version 3 software directly against clinical outcomes or events, independent of human interpretation of those metrics during the study. The device is intended to "assist clinical interpretation," and the clinician "remains ultimately responsible," but the performance data presented is on the software's outputs themselves.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation includes:

• Outcomes Data:
  • Major Adverse Coronary Events (MACE)
  • Mortality
  • Reduction in MACE/mortality after revascularization
• Clinical Events/Characteristics:
  • Angina during stress PET imaging
  • ST depression ≥1mm during stress PET imaging

8. The Sample Size for the Training Set

The document does not include information about a specific training set or its sample size. This submission appears to be evaluating the performance of an existing or updated algorithm, rather than describing the development and training of a new model.

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

As no training set is explicitly described, there is no information on how ground truth for a training set was established.

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