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Display: The device consists of a display to be used with the DyeVert Plus Disposable Kit or the Contrast monitoring Disposable Kit during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

DyeVert Plus Disposable Kit: The DyeVert™ Plus Contrast Modulation/Monitoring 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, Iohexol 300 or 350 mg/mL and Iopamidol 370 mgI/mL.

Contrast Monitoring Disposable Kit: The device 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 radiopaque contrast media.

The Osprey Medical DyeVert™ Plus Contrast Modulation/Monitoring System is a compatible system to manual contrast injections and provides fluid pathway resistance modulation and/or monitoring 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 DyeVert Plus Contrast Modulation/Monitoring System consists of the Display and the DyeVert Plus Disposable Kit.

The Contrast Monitoring System is a component of the DyeVert™ Plus Contrast Modulation/Monitoring System and also provided separately. 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. This allows for attentive physician decision-making of total contrast volume use during a patient case while allowing the physician's primary focus to remain on the image and therapeutic need of imaging. When sold separately, the Contrast Monitoring System consists of the Display and the Contrast Monitoring Disposable Kit.

The provided text is a 510(k) summary for a medical device (DyeVert™ Plus Contrast Modulation/Monitoring System, Contrast Monitoring System). It describes the device, its intended use, comparison to predicate devices, and a summary of non-clinical testing. However, it explicitly states: "No clinical testing was performed to support this 510(k) Premarket Notification."

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria from this document, as there was no clinical study mentioned for this specific 510(k) submission.

Here's an overview of what can be extracted regarding testing and criteria, though it pertains to non-clinical (bench) testing:

Acceptance Criteria and Device Performance (Non-Clinical)

Study Details (Based on Non-Clinical Testing Summary)

Since the document explicitly states "No clinical testing was performed to support this 510(k) Premarket Notification," most of the requested fields related to clinical studies and ground truth cannot be answered from the provided text.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable/Not provided for non-clinical bench testing in the detail requested. The "test set" would refer to the various components and conditions evaluated during bench testing. Data provenance is not specified.

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

   • Not applicable as no clinical study or expert-adjudicated ground truth for a test set is mentioned.

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

   • Not applicable as no clinical study or expert adjudication is mentioned.

4. 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:

   • No MRMC clinical study was performed. The device described is a contrast modulation/monitoring system, not an AI-assisted diagnostic imaging tool with human reader involvement in interpretation.

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

   • No standalone clinical performance study was performed.

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

   • For the non-clinical testing, the "ground truth" would be established by engineering specifications, validated test methods, and industry standards (e.g., ISO, IEC, ASTM standards for materials, software, electrical safety, etc.).

7. The sample size for the training set:

   • Not applicable as no AI/machine learning model requiring a training set is described in the context of clinical performance. The "device performance testing" likely involves internal validation against pre-defined engineering parameters rather than machine learning training.

8. How the ground truth for the training set was established:

   • Not applicable as no AI/machine learning model requiring a training set is described.

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