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HeartSee™ software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in cclmin/q. 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™ is intended for use by trained professionals, such as nuclear technicians, 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 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 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 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 software quantifies absolute rest and stress myocardial perfusion per unit tissue (cc/min/gm), 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 and the predicate K231731 also display stress subendocardial to subepicardial ratio and subendocardial stress to rest ratio on relative activity tomograms, and stress relative topogram maps expressed as a fraction of maximum cc/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 cc/min/g, CFR and CFC, HeartSee has software for determining left ventricular ejection fraction (EF) by PET-CT using Rb-82 compared to EF.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria for the HeartSee™ Cardiac P.E.T. Processing Software.

The document is a 510(k) premarket notification clearance letter from the FDA. It states that:

• This device, HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4, is substantially equivalent to a legally marketed predicate device (Optional Screen Displays For HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 (K231731)).
• The primary changes from the predicate device are a software platform migration to the Windows operating system, minor software application updates, and cybersecurity enhancements.
• The core functionality of determining quantitative myocardial perfusion, Coronary Flow Reserve (CFR), and Coronary Flow Capacity (CFC) map, along with their displays and left ventricular ejection fraction (EF) determination, remains essentially the same as the predicate.
• No new clinical testing was performed in support of this 510(k) Premarket Notification. The substantial equivalence is based on nonclinical testing of the predicate device, combined with system testing and cybersecurity testing of the proposed device, due to the nature of the modifications being primarily platform and minor updates.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, ground truth types, or training set details because this information is not present in the provided FDA 510(k) clearance letter.

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HeartSee Software for cardiac position tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in co'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 by quantification of their severity.

HeartSee is intended for use by trained professionals, such as nuclear technicians, 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 is a software tool for cardiac positron emission tomography (PET) for determining regional and global absolute rest and stress myocardial perfusion in cc/min/q. 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 of known coronary artery disease. HeartSee 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 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 software quantifies absolute rest and stress myocardial perfusion per unit tissue (cc/min/gm), 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.

The provided text does not contain detailed acceptance criteria and the results of a study proving the device meets these criteria. The document is a 510(k) summary for the HeartSee Cardiac P.E.T. Processing Software (K181343).

Here's what can be extracted based on the prompt's requirements:

1. A table of acceptance criteria and the reported device performance

The document states: "The verification and validation testing of the predicate device verification is deemed to be sufficient for the proposed device as the devices are identical with the exception of branding." This indicates that no new performance data or acceptance criteria specific to K181343 are presented because its performance is considered identical to its predicate (K171303). Therefore, a table for K181343's performance against specific acceptance criteria is not provided in this document.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided for K181343. Since no new testing was performed for K181343, this information would pertain to the predicate device (K171303) and is not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided for K181343. This information would relate to the testing of the predicate device (K171303) and is not detailed here.

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

Not provided for K181343. This information would relate to the testing of the predicate device (K171303) and is not detailed here.

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

The document states: "No clinical testing was performed in support of this 510(k) premarket notification." Therefore, no MRMC comparative effectiveness study was done for this specific submission (K181343).

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

The document states: "No clinical testing was performed in support of this 510(k) premarket notification." Therefore, no standalone algorithm performance study was done for this specific submission (K181343).

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

Not provided for K181343. This information would relate to the testing of the predicate device (K171303) and is not detailed here.

8. The sample size for the training set

Not provided for K181343. This information would relate to the development and training of the algorithm for the predicate device (K171303) and is not detailed here.

9. How the ground truth for the training set was established

Not provided for K181343. This information would relate to the development and training of the algorithm for the predicate device (K171303) and is not detailed here.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document explicitly states: "The proposed device and K171303 are software tools using identical standard, industrial computing hardware and applications. The code in the proposed software package is identical to K171303." And further: "The verification and validation testing of the predicate device verification is deemed to be sufficient for the proposed device as the devices are identical with the exception of branding."

This means that no new study was performed for K181343 to demonstrate its performance against acceptance criteria. The device is considered substantially equivalent to a previously cleared predicate device (K171303) because it is essentially the same software, differing only in branding. Therefore, the prior testing and validation of the predicate device (K171303) is the "study" referenced, and its acceptance criteria and performance data are considered applicable to K181343 by extension. The details of that predicate study are not present in this document.

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