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DyeVert™ NG Contrast Reduction System: The DyeVert™ NG Contrast Reduction System is to be used for the controlled infusion and contrast volume reduction of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mg/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/mL.

DyeVert™ Plus Contrast Reduction System: The DyeVert™ Plus Contrast Reduction System consists of a Display and DyeVert Plus Disposable Kit. The system is to be used for contrast volume reduction and for the monitoring of radiopaque contrast media during angiographic or CT procedures with the following agents: Iodixanol 270 or 320 mg/mL, lohexol 300 or 350 mg/mL and Iopamidol 370 mg/ mL.

DyeTect™ Contrast Monitoring Disposable Kit: The DyeTect™ Contrast Monitoring Disposable Kit consists of a Smart Syringe and Pressure Module to be used with the Contrast Monitoring Display during angiographic or CT procedures requiring controlled infusion of radiopague contrast media.

Smart Syringe: The Smart Syringe is to be used with the DyeVert™ Plus Contrast Reduction System or the Contrast Monitoring System. The DyeVert™ Plus Contrast Reduction System is to be used for contrast volume reduction and for the monitoring of radiopaque contrast media during angiographic or CT procedures with the following agents: Iodixanol 270 or 320 mg/l mL, Iohexol 300 or 350 mgI/mL and Iopamidol 370 mg/mL. The Contrast Monitoring System is to be used during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

DyeVert Plus EZ Disposable Kit: The DyeVert™ Plus EZ Contrast Reduction System consists of a Display and DyeVert Plus EZ Disposable Kit. The system is to be used for contrast volume reduction and for the monitoring of radiopaque contrast media during angiographic or CT procedures with the following agents: Iodixanol 270 or 320 mg/mL, Iohexol 300 or 350 mg/mL and Iopamidol 370 mgI/mL.

The DyeVert NG, DyeVert PLUS and DyeVert PLUS EZ Systems are compatible to manual contrast injections and provide fluid pathway resistance modulation such that excess contrast volume (i.e. contrast that is not needed for diagnostic or therapeutic purposes also referred to as 'refluxed contrast') is minimized in the patient's vasculature. This allows for a reduction in total contrast agent volume during coronary or peripheral imaging: while maintaining adequate image quality. The DyeTect System is compatible to manual contrast injections and provides monitoring of the amount of contrast delivered to the patient. The Smart Syringe is also manufactured as a replacement that can be used with the DyeVert Plus, DyeTect or DyeVert Plus EZ systems.

The provided document, a 510(k) Premarket Notification from the FDA, does not contain information on acceptance criteria for device performance or a study proving that a device meets those criteria in the context of AI/ML or diagnostic performance. Instead, this document is a regulatory approval for several medical devices related to contrast reduction and monitoring (DyeVert™ NG, DyeVert™ PLUS EZ, DyeTect™, and Smart Syringe) based on their substantial equivalence to previously cleared predicate devices.

The key point of this submission is a change in the sterilization process for these devices, not a new clinical performance study assessing their diagnostic or treatment efficacy relative to specific performance metrics.

Therefore, I cannot extract the detailed information requested in your prompt (e.g., acceptance criteria for device performance, sample sizes for test/training sets, expert ground truth establishment, MRMC study, standalone performance, etc.) from this document. The document explicitly states:

• "No clinical testing was performed to support this 510(k) Premarket Notification." (Page 6)

The "studies" mentioned are non-clinical testing related to the sterilization process and material residuals, demonstrating that changing the sterilizer and revised sterilization process does not negatively impact safety or basic functionality as compared to the predicate devices. These are not performance studies in the context of diagnostic accuracy, AI model performance, or clinical outcomes that would typically have the acceptance criteria and study designs you've described.

The document focuses on:

• Sterilization validation: Conformance to ISO 11135:2014 for Ethylene Oxide sterilization to ensure sterility assurance level.
• Residuals testing: Conformance to ISO 10993-7:2008 for Ethylene Oxide sterilization residuals.
• Comparison to predicate devices: Highlighting that the only change is the sterilization process and that intended use, indications for use, and fundamental scientific technology remain the same.

In summary, the provided text does not contain the information needed to fill out your requested table and answer the specific questions about device performance and clinical study details related to diagnostic or treatment efficacy.

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