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The Cerebral Blood Perfusion Package is an application software that permits cerebral perfusion imaging based upon dynamic CT images that are acquired after the injection of contrast. The software allows for visualization of apparent blood flow in brain tissue and pictorially illustrates perfusion parameters (CBP- cerebral blood perfusion, CBV cerebral blood volume, mtt - mean transit time, and ERR -CBP residual difference SD map) from a set of dynamic images. This package when used by a trained physician will assist in the assessment of the type and extent of cerebral perfusion disturbances. Additionally, the software allows for measurement of various values such as mean value, standard deviation, area and distance.

The CSCP-001A is an image analysis software package, that will be applied to the Toshiba TSX-101A (Aquilion) and TSX-021A (Asteion) CT schanners, that allows the user to process dynamic scan image data that are acquired in conjunction with a contrast bolus. The package allows visualization of the data in image map formats. Additionally, the package allows the display of numeric data via the image analysis software that is integral to the package. The software is post processing and does not control the x-ray features of the system.

The provided text is a 510(k) summary for the Cerebral Blood Flow Analysis System (CBP), Model Number CSCP-001A. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria through a detailed study. As such, the document does not contain the detailed information necessary to answer all aspects of your request.

Specifically, there is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, or the number/qualifications of experts for ground truth establishment.
• Adjudication methods.
• A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• A standalone (algorithm-only) performance study.
• The type of ground truth used (e.g., pathology, outcomes data) for a test set.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily describes the device, its intended use, and its technological characteristics in relation to predicate devices. It states: "Based upon the above considerations TAMS believes that this upgrade package, Cerebral Blood Flow Analysis System (CBP), Model Number CSCP-001A is substantially equivalent to the predicate devices. This package and the predicate devices are all post-processing and provide the same features of visualization and numeric data. Additionally this package and the predicate devices have the same indications for use."

This indicates that the primary "study" or justification for approval was a comparison to predicate devices, focusing on similar features and intended uses, rather than a quantifiable performance study against specific acceptance criteria as you've requested.

Therefore, I cannot populate the table or answer the specific questions about study methodology, sample sizes, expert involvement, or ground truth that you've asked based on the provided text.

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