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DynamicIQ enables visualization and quantification of PET tracer pharmacokinetics based on whole body dynamic PET images. PET tracer pharmacokinetics include the physiological parameters of tracer uptake rate of the tracer and total blood distribution volume (Vd) that allow for analyzing the tracer accumulation over time, providing additional information that may help in the evaluation of SUV measurements on PET static images. The output of DynamicIQ is intended to be used by appropriately trained healthcare professionals as adjunct information for the review, analysis, and communication of PET static images for diagnosis, staging, treatment planning and monitoring. The parametric images should always be considered in addition to the conventional static PET images, which are the primary source to assist with diagnosis.

DynamiclQ is a post processing and visualization for visualizing and quantifying dynamic and static PET DICOM series. The software provides FDG tracer pharmacokinetics by generation of parametric images based on dynamic PET scans. The parametric images include physiological parameters of tracer uptake rate (Ki), metabolic rate of FDG and total blood distribution volume (Vd). In addition to the FDG Tracer pharmacokinetics, the software also performs the conventional review, analysis and communication of conventional PET static images, CT and MR images.

DynamicIQ assists with the clinical workflow by providing adjunct information of FDG tracer pharmacokinetics along with conventional PET static images for cross reference. The adjunct information of FDG tracer pharmacokinetics also help with analyzing the images that could have variability of quantitative measurements due to differences in uptake time, patient body size and blood glucose levels, leading to better characterization of tracer uptake compared to SUV alone.

The provided text describes the regulatory submission for DynamicIQ, a post-processing and visualization software for PET images. It mentions a study for performance testing but does not provide specific details on the acceptance criteria, reported performance values, or the study design.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test set, data provenance, number of experts for ground truth, expert qualifications, or adjudication methods for the test set.
3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or standalone performance.
4. Specifics on the type of ground truth used.
5. Sample size or ground truth establishment for the training set.

The document states that "DynamicIQ has successfully completed the design control testing per GE's quality system. It was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. No additional hazards were identified, and no unexpected test results were observed." It also mentions "Performance testing (Verification, Validation)" and "Safety Testing (Verification)" were applied. This confirms that studies were conducted to ensure the device meets its design requirements and safety standards, but no specific details of those studies are included in this FDA 510(k) summary.

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