Search Results

The NeuroQ™ 3.8 program is used to regionally quantify activity in brain PET and SPECT scans using a ROI count method. It displays co-registered PET, SPECT and CT images, along with output from quantification of activities reflecting regional concentrations of FDG, amyloid imaging agents, SPECT perfusion and dopamine transporter radiotracers, relative to activities in any of several user-selected reference regions or whole brain. It provides for displaying and quantifying the regional differences between two PET or SPECT brain studies for the same patient, or the levels of amyloid imaging agents retained in specified brain regions of a patient, and for assisting the user in the examination of brain scans acquired for assessing neurodegenerative processes underlying symptoms of cognitive and movement disorders by comparing regional activity values to each other and to those in brain scans acquired for asymptomatic control subjects. These neurodegenerative processes can be Alzheimer's disease, Lewy body dementia. Parkinson's disease with dementia, vascular dementia, and frontotemporal dementia.

The product is intended for use by trained nuclear medicine physicians. The clinician remains ultimately responsible for the final interpretation and diagnosis based on standard practices and visual interpretation of all SPECT and PET data.

NeuroQ™ 3.8 has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can also be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, to perform an image fusion of the patients PET and CT data, and to provide analysis of amyloid uptake levels in the brain. The program can also be used to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. This program was developed to run in the IDL operating system environment, which can be executed on any nuclear medicine computer systems which support the IDL software platform. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative, pre-defined manner for the NeuroQ 3.8 based on its performance metrics. Instead, it relies on the safety and effectiveness established in previous versions and through inter-observer reproducibility and accuracy for basal ganglia analysis.

Ask a specific question about this device