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The device consists of a display 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.

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 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. Age, diabetes, moderate and severe chronic kidney disease and heart failure on presentation are leading factors for when to consider renal protection measures such as contrast minimization tools and processes.

The DyeVert Plus EZ Contrast Reduction System consists of the:

1. Contrast Monitoring Display (provided separately) and
2. DyeVert Plus EZ Disposable Kit.

The DyeVert Plus EZ Disposable Kit consists of the Smart Syringe and DyeVert Plus EZ Module. The DyeVert Plus EZ Disposable Kit is intended to be used with the Contrast Monitoring Display to allow monitoring and display of contrast volumes manually injected. Volumes are displayed and compared to physician entered contrast usage thresholds during angiographic procedures.

The DyeVert Plus EZ Module has been designed for use with standard injection syringes and manifolds with Luer fittings that have been demonstrated to comply with ISO 594 "Conical fittings with a 6% luer taper for syringes, needles and certain other medical equipment"; and the catheter configurations listed below. Utilization of catheters beyond those listed has not been substantiated.

This document describes the DyeVert™ PLUS EZ Contrast Reduction System, a medical device designed for contrast volume reduction and monitoring during angiographic or CT procedures. The submission is a 510(k) premarket notification (K181936), indicating a claim of substantial equivalence to a legally marketed predicate device.

It's important to note that the provided text focuses on the device's technical specifications, non-clinical bench testing, and comparison to its predicate. No clinical testing was performed or reported in this submission to demonstrate the device's performance in humans or improvement in human reader performance.

Therefore, the following information will be extracted primarily from the non-clinical testing sections, as clinical study data for device performance or human reader improvement is explicitly stated as not performed.

Acceptance Criteria and Reported Device Performance

Since no clinical study demonstrating human-in-the-loop performance or specific clinical outcomes was conducted, the acceptance criteria and reported performance relate to bench testing of the device's functional and safety characteristics.

Study Details

Given that no clinical study was performed, the sections below will reflect the information provided for the non-clinical bench testing.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly quantified as a "sample size" in the conventional sense for patient data. For bench testing, samples of the device components (e.g., DyeVert Plus EZ System, Disposable Kit components) were tested. The number of units tested for each specific test (e.g., how many devices were subjected to contrast diversion testing) is not provided, but the description implies a sufficient number were tested to satisfy the respective acceptance criteria for device performance.
   • Data Provenance: The data is from non-clinical bench testing performed by Osprey Medical, Inc. (the manufacturer) and third-party testing certification for electrical safety. The data is prospective in nature, as it was generated specifically for this submission to demonstrate device performance against pre-established engineering and safety specifications. No geographical provenance for the "data" in terms of patient population is relevant here as no patient data was used.

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

   • Not Applicable. For non-clinical bench testing, "ground truth" is established by engineering specifications, international standards (e.g., ISO 10555-1, IEC 60601-1, IEC 62304), and validated test methods. While engineers and quality assurance professionals with relevant expertise would conduct and interpret these tests, they are not "experts" in the context of establishing medical ground truth for a diagnostic AI model. The "Simulated Use design validation" involved "participants" who performed procedures and provided feedback, but these were likely users/clinicians assessing usability rather than experts establishing clinical ground truth for a specific medical condition.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging, where multiple experts assess cases and discrepancies are resolved. As this was non-clinical bench testing, such an adjudication method is not relevant.

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. The document explicitly states: "No clinical testing was performed to support this 510(k) Premarket Notification." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.

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

   • While the device contains "software" (Display software), it is an electromechanical system for managing contrast media infusion, not an AI or diagnostic algorithm that operates "stand-alone" in a diagnostic capacity. Its "performance" is based on mechanical and fluid dynamic principles (e.g., contrast diversion efficacy, accuracy of volume measurement) rather than image interpretation. Therefore, the concept of a "standalone" algorithmic performance study in the context of diagnostic AI is not applicable here. The software verification confirmed the software's compliance with IEC 62304:2006.

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

   • Not Applicable in the clinical sense. The "ground truth" for the non-clinical tests was based on engineering specifications, pre-defined acceptance criteria, and compliance with international standards (e.g., ISO, IEC, AAMI). For instance, "accuracy testing" had a ground truth of +/- 10% deviation from a known, actual volume.

7. The sample size for the training set:

   • Not Applicable. This device is not an AI/machine learning model in the conventional sense that requires a "training set" of data for learning patterns. It is an electromechanical device with embedded software.

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

   • Not Applicable. As no training set was used, no ground truth needed to be established for it.

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