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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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