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HiSpeed CT/i with Performix Tube and Warp Scan Option is intended to provide 0.8 second 360-degree helical or axial scans as well as increase the maximum tube heat capacity and provides additional mA settings over our existing system.

The option is a software control key for the HiSpeed system that increases the allowable speed (Warp Scan), for single rotation to 0.8 seconds for axial and helical scanning as well as 0.5 second rotation for partial scan. The Performix tube provides an additional tube option for use on the HiSpeed Gantry. It is a metal cased tube that has a heat capacity of 6.3MHU. For HiSpeed CT/i systems the maximum available power increases. The new tube takes advantage of power capabilities of the power distribution unit that is currently provided with the system. The increase in available power will not require a change in hardware.

The provided text is a summary of safety and effectiveness for a medical device modification (HiSpeed CT/i with Performix Tube and Warp Scan Option). It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared device (HiSpeed CT/i, K940606).

However, the document does NOT contain information about acceptance criteria, specific device performance studies to meet those criteria, sample sizes, expert involvement, ground truth establishment, or comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot populate the requested table or answer the specific questions directly from the provided text. The document focuses on describing the changes and asserting safety and equivalence based on adherence to standards and the nature of the modifications, rather than presenting a formal study with detailed performance metrics against acceptance criteria.

The information provided is more aligned with a premarket notification (510(k)) where the primary argument is substantial equivalence, rather than a detailed clinical trial report or a performance validation study against specific quantitative acceptance criteria.

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