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The MFI-Cardiac application is intended to provide processing of rest and stress myocardial perfusion positron emission tomography (PET) images with approved radiotracers that have been acquired with a singlescan or fast back-to-back scans without waiting for radiotracer decay between scans. The application models measurements of tracer uptake over time to aid in the processing of the images. Co-registration or fusion of volumetric data is provided as a quality control. The processed output images are reviewed on other devices by qualified medical professionals trained in the use of medical imaging devices.

MFI-Cardiac is a software medical device that facilitates the rapid acquisition and processing of rest and stress myocardial perfusion images (MPI) with positron emission tomography (PET) and approved radiotracers. The device processes rest+stress cardiac PET images that have been rapidly acquired using either a single scan with two administrations of the tracer (one at rest, the other at stress) or separate "back-to-back" rest and stress scans. The rapidly acquired rest and stress cardiac PET images are provided to MFI—Cardiac via digital image transfer in DICOM format.

In use, the device first performs a series of quality assurance tests to ensure data integrity and validity. The images are then processed to correct for residual activity from the 1st tracer administration (administered at rest) that affects the image obtained after the 2nd tracer injection (administered at stress). The device then outputs separated and corrected DICOM images at rest and stress; these images are offloaded to other devices for display and review by qualified healthcare professionals.

Here's a detailed breakdown of the acceptance criteria and study information for the MFI-Cardiac device, based on the provided FDA 510(k) summary:

MFI-Cardiac Acceptance Criteria and Study Information

The MFI-Cardiac device underwent performance evaluations to demonstrate its safety and effectiveness, including simulation studies and evaluations using patient datasets. The device is classified as having a "moderate" level of concern, meaning a software failure could directly result in minor patient injury.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary states that "Three performance evaluation studies were completed with all acceptance criteria met." However, the document does not explicitly list the quantitative acceptance criteria for each study. It describes the purpose of each study. Therefore, the "Reported Device Performance" column reflects that the studies were successful in meeting their unstated criteria.

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

• Test Set Sample Size: The document does not specify the exact number of cases or images used in the "patient dataset" for the performance evaluation and co-registration evaluation studies. It refers to "patient dataset with synthesized rest+stress images" in the plural, implying more than one, but no specific count.
• Data Provenance: Not explicitly stated. The document mentions "patient dataset," but does not specify the country of origin or whether the data was retrospective or prospective. The term "synthesized rest+stress images" suggests that existing patient data might have been manipulated or combined to create the test cases.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not provide information on any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 was not explicitly mentioned or described in the provided text. The device is for image processing and output, which are then reviewed by qualified medical professionals. The focus of the studies described is on the algorithm's performance in processing and correcting images.

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

Yes, the performance evaluation studies described are essentially standalone (algorithm only) performance assessments.

• "Simulation studies to evaluate device performance across the full range of rest and stress myocardial blood flows..."
• "Performance evaluation using patient dataset with synthesized rest+stress images to evaluate the performance of MFI-Cardiac for producing output (corrected) rest and stress images..."
• "Evaluation of rest-stress image co-registrations performed by MFI-Cardiac for ensuring that the estimate for residual rest tracer activity is aligned with the stress-phase images before the correction is applied."

These studies assessed the device's ability to process, correct, and align images autonomously, without direct human intervention in the real-time processing loop. The output images are then reviewed by humans, but the studies described focus on the algorithm's direct output.

7. The Type of Ground Truth Used

The ground truth appears to be established through simulation and comparison to "separate scans."

• For the simulation studies, the ground truth would be the known, controlled parameters of the simulated myocardial blood flows.
• For the performance evaluation using patient dataset with synthesized rest+stress images, the ground truth for the "corrected" images was implicitly the "rest and stress images obtained from separate scans." This suggests a comparison against an existing, established method or "gold standard" for acquiring uncorrected images.
• For the co-registration evaluation, the ground truth would involve the accurate anatomical alignment of different image phases, likely assessed computationally against ideal alignment.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set.

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

The document does not provide any information on how the ground truth for the training set, if any, was established. Given the nature of the device (processing and correction based on physical models rather than deep learning for classification), it's possible that traditional algorithmic development and tuning did not involve a distinct "training set" in the same way a deep learning model would.

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The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration.

The NM or PET data can be coupled with registered and/or fused CT or MR scans, and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclical structures in scanned body tissue for clinical diagnostic purposes.

DaTQUANT optional application enables visual evaluation and quantification of 1371-iofflupane (DaTscan™) images. DaTQUANT Normal Database option enables quantification relative to normal population databases of 271-ioflupane (DaTscan™) images. These applications may assist in detection of loss of functional dopamninergic neuron terminals in the striatum, which is correlated with Parkinson disease.

Q.Lung application may aid physicians in:

• · Diagnosis of Pulmonary Embolism (PE), Chronic Obstructive Pulmonary Disease (COPD), Emphysema and other lung deficiencies.
• Assess the fraction of total lung function provided by a lobe or whole lung for Lung cancer resection requiring removal of an entire lobe. bilobectomy or pneumonectomy.

O.Brain allows the user to visualize and quantify relative changes in the brain's metabolic function or blood flow activity between a subject's images and controls, when used with radiopharmaceuticals approved by the regulatory authority in the country of use, which may be resulting from brain function alterations in:

• · Epileptic seizures
• · Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, vascular dementia, and frontotemporal dementia.
• Inflammation
• Brain death
• · Cerebrovascular disease such as acute stroke, chronic and acute ischemia
• · Traumatic Brain Injury (TBI)

When integrated with the patient's clinical and diagnostic information, O.Brain application may aid the physician in the interpretation of cognitive complaints, neuro-degenerative disease processes and brain injuries.

The Alcyone CFR application allows for the quantification of coronary vascular function by deriving Myocardial Blood Flow (MBF) and then calculating Coronary Flow Reserve (CFR) indices on data acquired on PET scanners and on stationary SPECT scanners with the capacity for dynamic SPECT imaging. These indices may add information to physicians using Myocardial Perfusion Imaging for the diagnosis of Coronary Artery Disease (CAD).

The Xeleris 4.0 is a Nuclear Medicine software-only device designed for general nuclear medicine processing & review procedures for detection and quantification of radioisotope tracer uptake in the patient body, using a variety of processing modes for various clinical applications types defined by anatomy and/or function of interest, radiopharmaceuticals, NM system acquisition set-up, etc., and various features designed to enhance image quality.

The Xeleris 4.0 is a modification of its predicate device Xeleris 3.1 (K130884) by introducing the following additional clinical applications:

1. Q.Lung - Q.Lung application provides processing, quantification, and multidimensional review for pulmonary scintigraphy for display and quantification of global and regional ventilation (V) and perfusion (P) on SPECT and SPECT/CT studies.

2. Q.Brain - Q.Brain application features automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in control subjects. The resulting quantification is presented using volume of interests, voxel-based and 3D stereotactic surface projection maps of the brain.

Q.Brain image analysis standardizes individual brain shapes into a standard atlas shape while preserving the functional information measured by SPECT and PET imaging.

SPECT/PET co-registration to MR and fusion display capabilities allows functional findings to be related to anatomy and offers visualization of structural abnormalities.

3. Alcyone CFR – Alcyone CFR application allows for the quantification of coronary vascular function by deriving the Myocardial Blood Flow (MBF) and Coronary Flow Reserve (CFR). These indices may add information to physicians using Myocardial Perfusion Imaging for the diagnosis of Coronary Artery Disease (CAD).

The provided document is a 510(k) Premarket Notification for the GE Healthcare Xeleris 4.0 Processing and Review Workstation. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with explicit performance metrics.

Therefore, the requested information (acceptance criteria, specific performance metrics, sample sizes for test/training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not explicitly available in the provided text for the Xeleris 4.0 device.

The document states that:

• The Xeleris 4.0 is a modification of its predicate device Xeleris 3.1 (K130884) by introducing additional clinical applications such as Q.Lung, Q.Brain, and Alcyone CFR.
• Clinical studies were not required to support substantial equivalence for Xeleris 4.0.
• "Bench measurements on representative clinical datasets were used to demonstrate the outputs of the software applications, and to substantiate their clinical performance."
• "Development and testing of the new features included use of clinically acquired data-sets to ensure the intended clinical outputs were achieved."
• Verification, including hazard mitigation, was performed with "results demonstrating the Xeleris 4.0 Processing and Review Workstation software met its design inputs and clinical performance requirements."

Without a detailed clinical study report, which is not part of this 510(k) summary, it's impossible to create the table and answer the specific questions about acceptance criteria and study details.

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