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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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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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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 mgl/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.

The Smart Syringe is a component to the DyeVert™ Plus Contrast Reduction System and Contrast Monitoring System. The Smart Syringe is not intended to be used independently. The Smart Syringe is a control syringe with wireless communication capability to the Osprey Medical DyeVert Plus and Contrast Monitoring Display.

The provided text describes the 510(k) premarket notification for the "Smart Syringe." However, it states that no clinical testing was performed to support this 510(k) Premarket Notification. Therefore, a study proving the device meets acceptance criteria, as typically understood in the context of clinical or standalone algorithm performance, is not available in the provided document.

Instead, the submission relies on non-clinical bench testing and a demonstration of substantial equivalence to a previously cleared predicate device. The acceptance criteria and performance are therefore related to these non-clinical tests.

Here's an analysis based on the provided text, addressing your points where possible, and indicating where information is not available due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: The document does not specify the sample sizes for the individual non-clinical tests (e.g., how many syringes were tested for flow rate or durability). It refers to "testing" in a general sense.
• Data Provenance: Not applicable in the context of clinical data. The non-clinical tests were performed by the manufacturer, Osprey Medical, Inc., or leveraged from previous submissions for the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• This information is not applicable as no clinical test set requiring expert-established ground truth was used for this 510(k) submission.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was performed to support this 510(k) Premarket Notification."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not applicable. The "Smart Syringe" is a physical medical device, a component of a contrast reduction/monitoring system, not an AI algorithm. Its performance is related to its mechanical and electrical functions and its interaction within the larger system.

7. The Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" was established by engineering and quality standards, defined by "prior established acceptance criteria" and adherence to various international standards (e.g., IEC 60601-1, ISO 11135-1, IEC 62304, ASTM D4169, ISO 11607, ISO 10993-1). These standards and internal specifications effectively serve as the "ground truth" for the device's physical, electrical, and biocompatibility performance.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. This device is not an AI algorithm that requires a "training set."

Summary:

The K171698 submission for the Smart Syringe relied entirely on non-clinical bench testing and adherence to established engineering and regulatory standards to demonstrate substantial equivalence to its predicate device. No clinical data or AI algorithm performance was part of this particular submission. The "acceptance criteria" and "performance" described are related to these non-clinical, quantifiable metrics such as flow rate, pressure, sterilization efficacy, and biocompatibility, as verified against pre-defined specifications and international standards.

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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.

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, Iohexol 300 or 350 mg/mL and Iopamidol 370 mg/ mL.

The Osprey Medical DyeVert" NG and DyeVert" Plus Contrast Reduction 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 the total contrast agent volume during coronary or peripheral imaging to the patient; while maintaining adequate image quality.

The provided text is a 510(k) summary for the DyeVert™ NG and DyeVert™ Plus Contrast Reduction Systems. This document pertains to the regulatory clearance of a medical device intended to reduce contrast media volume during angiographic procedures. It's important to note that the information focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical efficacy studies for a novel AI algorithm.

Therefore, many of the requested categories related to AI performance, such as MRMC studies, effect size of human improvement with AI, standalone AI performance, ground truth establishment for AI training, and associated sample sizes, are not applicable or cannot be extracted from this document, as the device described is not an AI-powered diagnostic or predictive tool.

Here's an analysis of the acceptance criteria and supporting studies as presented in the document:

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

The document does not explicitly present a table of acceptance criteria and reported device performance in a summary format with specific quantitative targets and results for each. Instead, it describes general compliance with "prior established acceptance criteria" and successful completion of various tests.

However, based on the non-clinical testing summary, the acceptance criteria implicitly related to the device's functionality and safety can be inferred:

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

The document primarily describes non-clinical bench and lab testing. Therefore, the concept of a "test set" in the context of patient data or clinical images (which would typically have provenance like country of origin or retrospective/prospective) is not directly applicable here. The "sample size" refers to the number of units or iterations tested in the various non-clinical evaluations. Specific quantities for each test are not provided (e.g., number of devices tested for leak, or number of cycles for durability).

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

Not applicable. This device is not an AI algorithm requiring expert adjudication for establishing ground truth on a test set of medical images or data. The "ground truth" for the non-clinical tests would have been objective physical measurements or established pass/fail criteria according to international standards (e.g., sterility, material properties).

4. Adjudication method for the test set

Not applicable. As noted above, expert adjudication for a "test set" of medical data is not relevant for the non-clinical evaluation of this direct medical device.

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

Not applicable. This is not an AI-assisted diagnostic device, so no MRMC study or AI-related effectiveness assessment was performed or reported in this 510(k) summary.

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

Not applicable. This device is a physical contrast reduction system, not an algorithm.

7. The type of ground truth used

For this purely physical device and its non-clinical testing, the "ground truth" was established by:

• Objective physical measurements: For parameters like flow rate, peak pressure, leak, tensile strength, and distribution performance.
• Adherence to established standards: Such as ISO 11135-1:2014 for sterilization, ASTM D4169:2016 for distribution testing, and ISO 10993-1:2009 for biocompatibility. These standards define the acceptable criteria for performance and safety.
• Design specifications: The device's performance was measured against its internal design specifications.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm that requires a training set.

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

The Osprey Medical AVERT™ Contrast Modulation System allows for the modulation of contrast media during manual injections in coronary or peripheral imaging procedures. The AVERT System consists of a reusable, non-sterile apparatus (contrast modulator), which a force to a disposable sterile modulation reservoir with a standard, off-the-shelf 4-way stopcock and extension line. The contrast modulator utilizes an internal mechanism to apply a force to the modulation reservoir; allowing for modulated diversion of manual contrast injections. The force can be easily and quickly adjusted by moving the location of the pin as identified on the outer housing of the system, thereby increasing or decreasing the amount of force applied to the modulation reservoir. The contrast modulator is attached to a wheeled stand and is positioned near the patient, outside of the sterile field.

The provided document describes the AVERT™ Contrast Modulation System, for which Osprey Medical, Inc. submitted a 510(k) premarket notification (K150485). The document indicates that this submission is for a minor modification to an already cleared predicate device (K140425).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes for each test set. However, it indicates that testing was performed and/or leveraged from the predicate (K140425). The tests are described as "Bench testing," "Simulated use (animal)," and "Shelf-life, distribution and shipping testing." There is no mention of human clinical test sets, as the submission explicitly states "No clinical testing was performed."

The data provenance is largely retrospective in the sense that much of the data was already generated and validated for the predicate device. For the specific modification (new spring component in model RMS-ISOV-300-C), new bench testing was performed. The origin of the simulated use (animal) data is not specified beyond "animal."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. Given that the testing primarily involved bench, animal, and physical performance tests, the "ground truth" would likely be objective measurements against predefined engineering and biological specifications, rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods are typically relevant for clinical studies involving subjective interpretations, which were not performed for this submission.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable. The AVERT™ Contrast Modulation System is an angiographic injector and syringe system, a medical device for controlled infusion of contrast media. It is not an AI-powered diagnostic or assistive tool for human readers, so MRMC studies and "AI assistance" effect sizes are irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The AVERT™ Contrast Modulation System is a hardware device that modulates contrast media during manual injections. It is not an algorithm or software that operates in a standalone capacity.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the various tests was based on:

• Established product specifications and performance requirements for bench testing (flow rate, pressure, diversion, adjustability).
• Validated standards for sterilization (ISO 11135-1:2007) and biocompatibility (ISO 10993-1:2009).
• Standardized testing methods for shelf-life and distribution (ASTM D4169).
• Assessment of safety and effectiveness in simulated use (animal) models against expected physiological responses.

In essence, the ground truth was primarily based on objective engineering and biological performance metrics and compliance with recognized standards, rather than clinical expert consensus, pathology, or outcomes data, as no clinical studies were performed.

8. The Sample Size for the Training Set

This question is not applicable. The AVERT™ Contrast Modulation System is a physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for this type of device.

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