(69 days)
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)
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| LVEF Measurement Comparability (vs. Emory Toolbox): (Specific metric, e.g., correlation coefficient, mean absolute difference, Passing-Bablok agreement, acceptable limits, or non-inferiority margin) | "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." (No specific quantitative performance metrics provided in this document). |
| Association with Mortality/MACE (for CFR and stress perfusion): (e.g., Specific hazard ratio, p-value, or area under ROC curve thresholds) | CFR and separately stress perfusion "associate significantly with mortality, major adverse coronary events (MACE) and their significant reduction after revascularization." (No specific quantitative performance metrics provided). |
| Association with Angina/ST depression (for subendo/subepicardial ratio, stress/rest ratio, RSF): (e.g., Specific sensitivity, specificity, or AUC thresholds) | "the stress subendo/subepicardial ratio, the subendocardial stress/rest ratio and the relative stress flow (RSF) associate with angina or ST depression ≥1mm during stress PET in patients with only mildly reduced CFC and no severely reduced CFC." (No specific quantitative performance metrics provided). |
Study Details:
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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.
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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.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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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.
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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.
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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.
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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.
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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.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.