Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The cardiac position emission tomography (PET) analysis tool, HeartSee is a software package intended for use by nuclear medicine and nuclear cardiology physicians and technologists to facilitate image interpretation. Archiving of output data will be supported for clinical diagnostics, quality control, and research.

HeartSee is intended for processing of DICOM images, visual analysis and quantification of relative myocardial tracer uptake, and quantification of absolute myocardial blood flow and CFR when applied to diagnostic cardiac PET images in patients with suspected or known coronary artery disease.

The cardiac positron emission tomography (PET) analysis tool HeartSee is a software package intended for use by nuclear medicine and nuclear cardiology physicians and technologists to facilitate image interpretation. Archiving of output data will be supported for clinical diagnostics, quality control, and research.

HeartSee contains two fundamental components. First, the software can import cardiac PET images in DICOM format from any camera manufacturer. These images can be reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. A trained, licensed physician can interpret these processed images as per standard practice.

Second, the CFR software can quantify absolute myocardial blood flow per unit tissue (cc/min/gm) in stress and rest PET cardiac images and quantitatively assess the coronary flow reserve (CFR).

To compute coronary flow reserve (CFR) - the ratio of increased blood flow (stress) to baseline blood flow (rest) – three inputs are required: integrated arterial activity in the early part after bolus injection, average myocardial activity in the late part after bolus injection, and correction factors for partial volume effects of the PET scanner. The first number comes from a region of interest (ROI) drawn in the thoracic aorta or left atrium on images taken soon after radionuclide bolus administration. The second number comes from the topographic maps of myocardial uptake acquired later after radiotracer injection. The third number varies by PET camera and will be initialized in a user preference file.

HeartSee is a software package that uses standard, industrial computing hardware and applications.

This device is HeartSee, a cardiac PET analysis software.

Please note that the provided document is a 510(k) summary, which often provides less granular detail on study designs compared to full study reports or publications. Therefore, some information may not be explicitly available and will be noted as such.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state formal acceptance criteria with numerical thresholds. Instead, it relies on demonstrating substantial equivalence to predicate devices (K090178 and K113754). This typically means the new device performs similarly well or not worse than the predicates.

However, the document mentions specific validation studies for its two main functionalities:

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

• Test Set Sample Size: 82 patients.
• Data Provenance: The document does not explicitly state the country of origin. It mentions data from patients with coronary artery disease and "cardiac PET images acquired at our institution." Given the contact information for K. Lance Gould, M.D. at the University of Texas Medical School at Houston, it is highly likely the data is from the USA.
• Retrospective or Prospective: The wording "MBF from 82 patients processed by the new algorithm was compared to MBF previously calculated by an independent algorithm" suggests that the data was retrospective, as the "previously calculated" values imply existing data.

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

The ground truth for the quantitative component (MBF and CFR) was established by an "independent algorithm" (presumably cfrQuant, predicate K113754), not directly by human experts in the sense of adjudication. Therefore, the concept of "number of experts" for establishing this specific ground truth isn't applicable in the traditional sense here.

For the visual interpretation component, the document states: "A trained, licensed physician can interpret these processed images as per standard practice." This implies standard clinical practice where a single (or multiple, depending on practice) trained, licensed physician would interpret the images. However, no specific number of experts or their qualifications for a formal ground truth establishment for this visual component are detailed in the 510(k) summary.

4. Adjudication Method for the Test Set

For the quantitative component (MBF and CFR), the adjudication method was a comparison against a "previously calculated" value from an "independent algorithm" (predicate K113754). This is a direct algorithmic comparison, not a human adjudication method like 2+1 or 3+1.

For the visual interpretation component, no specific adjudication method is described within the context of a validation study for the 510(k) submission.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not described in this 510(k) summary. The validation focused on the standalone performance of the algorithm and its correlation with a predicate algorithm.

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

Yes, a standalone performance study was done for the quantitative components (MBF and CFR). The study directly compared the HeartSee algorithm's output for MBF and CFR to the output of an "independent algorithm" (the predicate device, cfrQuant). The correlations (r=0.99) demonstrate the standalone performance of the HeartSee algorithm.

7. The Type of Ground Truth Used

• For MBF and CFR Quantification: The ground truth was "previously calculated" values from an "independent algorithm" (the predicate device, cfrQuant). This can be classified as a form of algorithmic reference standard or established method comparison.
• For Visual Interpretation/Image Reorientation: The implied ground truth relies on standard clinical practice and expert interpretation, but a formal ground truth definition for a validation study is not detailed.

8. The Sample Size for the Training Set

The 510(k) summary does not provide information on the sample size used for the training set for the HeartSee device. This type of detail is often not included in 510(k) summaries.

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

The 510(k) summary does not provide information on how the ground truth for the training set was established, as it does not describe the training process or dataset.

Ask a specific question about this device