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The Vantage software has been developed to aid clinicians in the assessment and quantification of pathologies derived from PET and PET-CT brain scans. The software is deployed via Advantage Windows Workstation and PET-CT scanner console and is organized as a series of workflows steps, which are specific to use with particular drug and disease combination.

The software aids in the assessment of human brain scans enabling automated analysis through quantification of the comparison of local peak activity values at standardized anatomical locations with the corresponding reference normal peak activity in age stratified control subjects. The resulting quantification is presented to the user through 3D stereotactic surface projection maps of the brain. The package allows the user to generate information regarding relative changes in PET-FDG metabolic activity between a subjects images and age stratified controls, which may be resulting from brain function alterations by neurodegenerative processes.

CT fusion to PET offers visualization of structural abnormalities, which may result from brain injury, trauma, disease or dysfunction, such as subdural heratom tumor, stroke (or cerebrovascular disease) etc. Such tools may aid the physician in the rule out process.

The Vantage package includes automated analysis and review of PET and PET-CT brain scans. It has been developed to aid in assessment of human brain scans hrough quantification of the comparison of local peak activity values at standardized anatomical locations with the corresponding reference normal peak activity in age stratified normal database (or asymptomatic control subjects as defined). It rage a basic review of any PET brain scan, realignment of the PET volume to a standard attas and comparison to brain scans derived from control subjects or prior PET and/or MR scans. Results are displayed in user-friendly graphical format as Z-score, where Zscore is the scale of the deviation from the normal mean, relative to corresponding standard deviation.

The provided text does not contain detailed information about a specific study with acceptance criteria and its outcomes. It primarily describes the GE Vantage PET Neuro Software, its indications for use, and its substantial equivalence to predicate devices (Syntermed NeuroQ and Mirada Solutions Scenium) for 510(k) clearance.

Therefore, I cannot populate the table of acceptance criteria and reported device performance, nor can I provide details on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document only briefly mentions aspects relevant to some of your questions but does not provide the specific details requested to answer them thoroughly.

Here's an analysis of what can be extracted and what is missing:

• 1. A table of acceptance criteria and the reported device performance: This information is not present in the document provided. There are no explicit acceptance criteria or performance metrics reported.
• 2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): This information is not present.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): The document states that the "asymptomatic control group is as defined and age stratified by a neurologist with medical expertise." This suggests a neurologist was involved in defining the control group for the normal database, which serves as a reference. However, it does not specify the number of experts, their qualifications for establishing ground truth for a test set, or details about the actual ground truth establishment process for a validation study.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not present.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not present. The document describes a "post processing tool" that "assists in regional assessment," implying it's an aid, but no MRMC study or effect size is mentioned.
• 6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: The device description hints at standalone functionality by providing "automated analysis through quantification" and Z-scores. However, specific standalone performance metrics or studies are not detailed. The focus is on assisting clinicians.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for comparison appears to be a "reference normal peak activity in age stratified normal database (or asymptomatic control subjects as defined)." This implies a clinical definition of "normal" or "asymptomatic" individuals, likely established by clinical experts (neurologists). It doesn't explicitly mention pathology or direct outcomes data for individual patient cases in a test set.
• 8. The sample size for the training set: This information is not present. The product uses an "age stratified normal database," which would conceptually serve a similar purpose to a training/reference set, but its size is not stated.
• 9. How the ground truth for the training set was established: The "asymptomatic control group is as defined and age stratified by a neurologist with medical expertise." This suggests the ground truth was established by expert definition and selection of control subjects, rather than a case-by-case ground truth labeling for a complex pathology scenario.

In summary, the provided K062393 document is a 510(k) summary focused on substantial equivalence to predicate devices, not a detailed clinical study report. It lacks the specific study design, performance metrics, and acceptance criteria you've requested.

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