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DyeVert™ Plus Contrast Reduction System
Smart Monitor
The device consists of a Smart Monitor to be used with the DyeVert Plus Disposable Kit, DyeVert Plus EZ Disposable Kit or the DyeTect Contrast Monitoring Disposable Kit during angiographic or CT procedures requiring controlled influsion of radiopaque contrast media.
DyeVert Plus Disposable Kit
The DyeVert™ Plus Contrast Reduction System consists of a Monitor 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/l mL.
DyeVert™ Plus EZ Contrast Reduction System
Smart Monitor
The device consists of a Smart Monitor to be used with the DyeVert Plus Disposable Kit, DyeVert Plus EZ Disposable Kit or the DyeTect Contrast Monitoring Disposable Kit 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 Monitor 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 mgI/mL and Iopamidol 370 mgI/mL.
DyeTect™ Contrast Monitoring System
Smart Monitor
The device consists of a Smart Monitor to be used with the DyeVert Plus Disposable Kit, DyeVert Plus EZ Disposable Kit or the DyeTect Contrast Monitoring Disposable Kit during angiographic or CT procedures requiring controlled influsion of radiopaque contrast media.
DyeTect Contrast Monitoring Disposable Kit
The DyeTect Contrast Monitoring Disposable Kit consists of a Smart Syringe and Pressure Module to be used with the Monitor during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

The Osprey Medical DyeVert™ Plus Contrast Reduction System is a compatible device to manual contrast injections and provides fluid pathway resistance modulation such that excess contrast volume (i.e. contrast that is not needed for diagnostic or therapeutic purposes) is minimized in the patient's vasculature and total contrast agent volume reduction occurs, while maintaining adequate image quality. The DyeVert" Plus Contrast Reduction System consists of a non-sterile monitor and EO sterilized disposable kit.
The DyeTect™ Contrast Monitoring Disposable Kit consists of EO sterilized Smart Syringe and Pressure Module. The system allows for real-time, wireless, monitoring and display of manually injected contrast volumes. Volumes are displayed and compared to a physician entered contrast usage threshold during angiographic procedures. The system provides a visual and audible indication of when the cumulated volume injected into the patient is approaching a physician determined contrast volume threshold.
The Osprey Medical DyeVert™ Plus EZ Contrast Reduction System is a compatible device to manual contrast injections and provides fluid pathway resistance modulation such that excess contrast volume (i.e. contrast that is not needed for diagnostic or therapeutic purposes) is minimized in the patient's vasculature and total contrast agent volume reduction occurs, while maintaining adequate image quality. The DyeVert" Plus EZ Contrast Reduction System consists of a non-sterile monitor and EO sterilized disposable kit.

Based on the provided text, the document is a 510(k) Premarket Notification from the FDA regarding Osprey Medical Inc.'s DyeVert Plus, DyeVert Plus EZ Contrast Reduction Systems, and DyeTect Contrast Monitoring System.

This document clearly states that NO CLINICAL TESTING WAS PERFORMED to support this 510(k) Premarket Notification. Therefore, the device performance is not proven through a clinical study as requested in the prompt. The "acceptance criteria" discussed are related to non-clinical bench testing and regulatory compliance, not performance metrics derived from patient data or AI algorithm evaluation.

Since no clinical study was performed, I cannot fill in the requested information points related to clinical performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance.

Here's what can be extracted regarding the non-clinical testing, tailored to address the prompt where possible, and explicitly stating where information is unavailable due to the lack of clinical testing:

Device: DyeVert™ Plus Contrast Reduction System, DyeVert™ Plus EZ Contrast Reduction System, DyeTect™ Contrast Monitoring System (Specifically the Smart Monitor component, as the disposable kits are unchanged from predicates).

1. A table of acceptance criteria and the reported device performance

As no clinical testing was performed, there are no performance metrics related to diagnostic accuracy, sensitivity, specificity, or inter-reader agreement. The "performance" here refers to meeting engineering and regulatory standards in non-clinical bench testing.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable as no clinical test set/patient data was used for performance evaluation. Non-clinical testing involved various engineering and simulated tests.
• Data Provenance: Not applicable for clinical data. The changes assessed were to the Smart Monitor component (software, memory, connectivity) compared to its predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. No clinical expert review was performed as there was no clinical study.
• Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. No clinical test set.

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

• MRMC Study: No. No clinical study or human reader component was involved in this 510(k) submission. This device is not an AI algorithm for image interpretation that would assist human readers in a diagnostic task. Its function is for contrast volume management and monitoring.
• Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable in the context of an "AI algorithm only" evaluation. The device (Smart Monitor) is a hardware component with software for real-time monitoring and display of manually injected contrast volumes. It doesn't perform diagnostic interpretation or AI-driven tasks that would have standalone algorithmic performance metrics. The performance evaluated was its accurate measurement and display of contrast volumes during manual injection, as detailed in the non-clinical bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not applicable for clinical ground truth. For the non-clinical bench testing, the "ground truth" was established by engineering specifications, calibrated measurement tools, and defined test protocols to verify the device's functional performance (e.g., volume accuracy, electrical safety standards).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is not an AI algorithm that undergoes a "training" phase with a dataset.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable.

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