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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.

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

• Test Set Sample Size: The document does not explicitly state the sample size used for the clinical validation studies that determined inter-observer reproducibility and accuracy for basal ganglia analysis. It refers to "clinical validation studies submitted in our previous 510(k) K041022 and 510(k) #: K072307."
• Data Provenance: Not specified directly in this document. It is implied that the data would be from SPECT DaTSCAN images, but the country of origin or whether it was retrospective or prospective is not mentioned.

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

• Number of Experts: The document mentions "inter-observer reproducibility... even between trainee interpreters using the module for quantifying basal ganglia sub regions." This implies at least two, and possibly more, interpreters were involved, including some who were trainees.
• Qualifications of Experts: It specifies "trainee interpreters," which suggests a mix of experience levels, potentially including more senior interpreters. No specific years of experience or board certifications (e.g., "radiologist with 10 years of experience") are provided.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1). The "inter-observer reproducibility" suggests direct comparison between interpreters' results rather than a formal adjudication process to establish a single ground truth from discordant reads.

5. If an MRMC Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not performed and is not mentioned in the provided text. The study focused on the performance of the algorithm itself (standalone or as a tool for interpreters).

6. If a Standalone Study was Done

Yes, a standalone evaluation of the algorithm's performance was done implicitly. The statement, "The sensitivity, specificity, and overall accuracy of quantification-based dichotomized interpretations were all at least 90%," refers to the algorithm's ability to classify scans, indicating a standalone assessment of its output. While the overall process involves user verification, these metrics are of the algorithm's output before physician integration.

7. The Type of Ground Truth Used

The ground truth for the basal ganglia analysis appears to be based on the characteristics of the SPECT DaTSCAN images themselves, specifically the "reduced dopamine transporter" status. This would likely be clinical diagnosis or expert consensus based on visual assessment of the images and clinical context, although the document does not definitively state how this specific ground truth was established. The "quantification-based dichotomized interpretations" indicate a binary classification (e.g., reduced vs. not reduced dopamine transporter).

8. The Sample Size for the Training Set

The document does not provide the sample size for the training set. It mentions "defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC)" for comparison, implying a database, but no specific numbers for training.

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

The text states the program uses "brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC)." This suggests the ground truth for this segment of the training/reference data was established through clinical evaluation ruling out neurodegenerative diseases or symptoms in these individuals. For other analyses (like amyloid or dopamine transporter), the method for establishing ground truth for training data is not detailed in this document.

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