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CortexID software has been developed to aid physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans.

The software aids in the assessment of human brain PET scans enabling automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest, voxel-based or 3D stereotactic surface projection maps of the brain. The package allows the user to generate information regarding relative changes in PET-FDG glucose metabolism.

CortexID Suite additionally allows the user to generate information in PET brain amyloid load between a subject's images and a normal database, which may be the result of brain neurodegeneration.

PET co-registration and fusion display capabilities with CT and MR allow PET findings to be related to brain anatomy and offers visualization of structural abnormalities, which may result from brain injury, trauma, disorder, disease or dysfunction, such as subdural hematoma, tumor, stroke, or cerebrovascular disease, etc.

CortexID Suite may aid physicians in the image interpretation process of PET studies conducted on patients being evaluated for cognitive impairment, or other causes of cognitive decline, and is an adjunct to other diagnostic evaluations.

CortexID, image analysis software, has been developed to aid clinicians in the assessment and quantification of pathologies derived from PET scans. The software enables the display, co-registration, and fusion of PET images with those from other modalities. It enables automated quantitative and statistical analysis of tracer uptake by registration to a standard template space and comparing intensity values. Additionally, CortexID assists with comparison of the activity in defined brain regions of individual scans relative to normal activity values as found in normal subjects. Quantification is presented using volumes of interest, voxel-based or 3D stereotactic surface projection maps of the brain.

Key features of the CortexID Suite include:
a. Integrated platform for FDG and Beta Amyloid analysis
b. PET-MR and PET-CT registration and fusion
c. Automatic reorientation and standardization
d. 3D SSP, Voxel based images and VOI statistics
e. Comparison with normals databases
f. Longitudinal Analysis
g. Q.Check
h. Summing input dynamic PET scan
i. Exam Summary (integrated report)
j. Easy Export
k. Multiple Reference Regions
l. Reoreintation
m. Region Overlay
n. Fully Customizable Interface
o. Preset Presentations
p. MR Template Image

The CortexID Suite is also made available as a standalone post processing application on the AW VolumeShare 5 workstation (K110834) that hosts advanced image processing applications.

The provided document is a 510(k) summary for the GE Medical Systems CortexID Suite software. It declares substantial equivalence to a predicate device and does not contain a study section with acceptance criteria and a detailed study proving the device meets those criteria.

Instead, it functions as a submission to the FDA, asserting that CortexID Suite is substantially equivalent to a previously cleared device (K062393 - CortexID). The determination of substantial equivalence is based on non-clinical tests and the assertion that "The subject of this premarket submission, CortexID Suite software did not require clinical studies to support substantial equivalence since it introduces analysis of new PET image contrast agents only. The clinical utility for the analysis of the new image processing has not been studied since modification does not significantly affect the clinical safety and performance."

Therefore, based on the provided text, I cannot extract the information required to populate the requested table and answer the specific study-related questions. The document explicitly states that clinical studies were not required for this submission.

Summary of unavailable information:

• Acceptance criteria and reported device performance table: Not provided in the document.
• Sample size used for the test set and data provenance: Not applicable as no clinical test set was used for substantial equivalence.
• Number of experts used to establish ground truth for the test set and qualifications: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study and effect size: Not applicable as no clinical studies were performed.
• Standalone (algorithm only) performance: Not explicitly stated or evaluated in the provided text as a separate study. The document focuses on the software and its features.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable (no explicit mention of training a new algorithm or clinical study).
• How ground truth for the training set was established: Not applicable.

The document focuses on:

• Identifying the device and its predicate.
• Listing the key features of the CortexID Suite.
• Stating the intended use/indications for use.
• Explaining the technological similarity to the predicate device.
• Detailing the non-clinical tests performed (compliance with DICOM standard, risk analysis, requirements reviews, design reviews, integration testing, performance testing, safety testing).
• Asserting that clinical studies were not required for this specific submission's substantial equivalence determination.

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