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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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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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The DyeVert™ NG Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

The DyeVert™ NG Contrast Modulation 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 mgI/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/mL.

The Osprey Medical DyeVert™ NG Contrast Modulation System (DyeVert 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 System consists of a disposable, single-use sterile device including a Reservoir and Diversion Valve. The device is positioned between a manual injection control syringe and an injection manifold via the DyeVert stopcock. The diversion valve responds to the contrast injection pressure administered by the physician manually and modulates the amount of contrast diverted to the reservoir.

The DyeVert System 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". The DyeVert System is designed for use with contrast media and catheter configurations as listed in the Instructions for Use.

The document provided is a 510(k) premarket notification for the DyeVert NG Contrast Modulation System. It describes the device, its intended use, and compares it to a predicate device. This is a submission for a modified device, and the review explicitly states "No clinical testing was performed to support this Special 510(k) Premarket Notification." This means that the device was approved based on its similarity to a previously cleared device (predicate device) and extensive bench testing, rather than a clinical study demonstrating its performance against specific acceptance criteria in human subjects.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them (especially in a clinical context with human readers, ground truth, and sample sizes) cannot be fully provided from this document as no clinical study was conducted.

However, I can extract the information related to bench testing and how its results demonstrated the device met pre-established acceptance criteria, even though those specific criteria aren't enumerated in detail.

Here's the breakdown of the available information:

No clinical study was performed for the DyeVert NG Contrast Modulation System.

The device's substantial equivalence was established through a comparison to a predicate device and extensive non-clinical (bench) testing. Therefore, many of the requested categories related to clinical study design and outcomes are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:

• "Device performance testing was performed and leveraged for flow rate, peak pressure reduction, contrast diversion, mechanical cycle testing and visual verification to design specifications for specific contrasts and catheter configurations."
• "Confirmation testing was conducted for priming, high pressure simulation, leak testing, reservoir capacity and tensile strength."
• "All testing passed and demonstrated product performance met all prior established acceptance criteria."
• "Biocompatible testing was leveraged from the predicate in accordance with ISO 10993-1:2009... All testing passed and meet prior established acceptance criteria."
• "Shelf-life, shipping and distribution testing... All testing passed and demonstrated product performance met all prior established acceptance criteria."

Specific Acceptance Criteria (Not explicitly detailed in the document):

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

• Test Set Sample Size: Not specified in the document for the non-clinical tests.
• Data Provenance: Non-clinical (bench) testing performed by Osprey Medical. The country of origin for this bench testing data is not specified, but the company is based in Minnetonka, Minnesota, USA. The testing is retrospective in the sense that it's performed on the finalized device design.

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

• Not applicable. No clinical study was performed that would require expert-established ground truth for a test set. Bench testing relies on objective measurements against pre-defined engineering and material specifications.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical study involving human assessment was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. No MRMC study was performed. The device is for contrast modulation, not for diagnostic interpretation by human readers.

6. Standalone Performance Study (Algorithm Only):

• Not applicable. This is a mechanical device, not an AI or algorithm-driven system. Its "performance" is mechanical and fluid dynamic, evaluated through bench tests.

7. Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" was the established design specifications, engineering standards (e.g., ISO, ASTM), and chemical/biological safety standards (e.g., ISO 10993). For instance, a flow rate measurement would be compared to a target flow rate specification.

8. Sample Size for the Training Set:

• Not applicable. This refers to a supervised learning algorithm context, which is not relevant for this device.

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

• Not applicable.

In summary, the K161505 submission for the DyeVert NG Contrast Modulation System is a "Special 510(k)" for a modified device. Approval was based on demonstrating substantial equivalence to a predicate device and comprehensive bench testing, which confirmed the device met all prior established performance, material, and safety acceptance criteria. No new clinical trials were conducted to support this specific submission.

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The DyeVert™ Contrast Modulation 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 Osprey Medical DyeVert™ Contrast Modulation System provides a second fluid pathway that modifies the overall system resistance as experienced during the physician's manual injection and allows for excess (i.e. contrast that is not needed for diagnostic or therapeutic purposes) contrast media to be diverted into a reservoir and away from the patient while maintaining adequate image quality. Excess contrast is typically a result of refluxed contrast within the patient's vasculature, retrograde to the desired image area. The DyeVert™ System allows for the modulated reduction of contrast media during manual injections in coronary or peripheral imaging procedures. The DyeVert™ System is a device for physician utilization during efforts to minimize total patient contrast volumes.

The DyeVert™ System consists of a sterile, single-use, fully-disposable apparatus. The source contrast container is connected to the reservoir chamber which has one tube directing contrast (through the manifold) to refill the injection syringe upon aspiration with preference to the diverted contrast volume prior to aspiration from the contrast source.

The provided text describes the DyeVert Contrast Modulation System and references a clinical study for its effectiveness. However, it does not provide the detailed acceptance criteria or the specific study that proves the device meets those criteria in the format requested (e.g., a table with acceptance criteria and reported performance metrics).

The document is a 510(k) summary for a medical device and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone performance study with detailed acceptance criteria. While it mentions a clinical trial, the information provided about that trial is limited and not structured to answer all aspects of your request.

Here's a breakdown of what can be extracted and what information is missing based on your prompt:

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

• Missing. The document does not provide explicit numerically stated acceptance criteria for key performance indicators (like minimum percentage contrast reduction, or maximum acceptable image quality degradation). It states "All testing passed and demonstrated product performance met all prior established acceptance criteria" for non-clinical tests, but these criteria are not detailed. For the clinical study, it reports a "mean reduction of 15.4% with a corresponding t-test p value of 0.0229" and "15.0% relative reduction." It also mentions "maintaining adequate image quality" and "one incident recorded as poor image quality...

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The Osprey Medical AVERT™ System allows for controlled infusion and contrast volume reduction during manual injection of radiopaque contrast media. The AVERT™ System is to be used for angiographic coronary and peripheral procedures with the following agents: Iodixanol 270 or 320 mgUml, Iohexol 300 or 350 mgI/ml, and Iopamidol 300 or 370 mgI/ml.

The Osprey Medical AVERT™ Contrast Modulation System provides a second fluid pathway that modifies the overall system resistance as experienced during the physician's manual injection and allows for excess (i.e. contrast that is not needed for diagnostic or therapeutic purposes) contrast media to be diverted into a reservoir and away from the patient during the manual injection of contrast media while maintaining adequate image quality. Excess contrast is typically a result of refluxed contrast within the patient's vasculature retrograde to the desired image area. The AVERT™ System allows for the modulated reduction of contrast media during manual injections in coronary or peripheral imaging procedures. The AVERT™ System is a device for physician utilization during efforts to minimize total patient contrast volumes.

The AVERT™ System consists of a reusable, non-sterile apparatus (contrast modulator), which applies 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 text does not contain detailed acceptance criteria or a comprehensive study report with all the requested information for the AVERT Contrast Modulation System. The document is an FDA 510(k) summary and approval letter, which primarily focuses on establishing substantial equivalence to a predicate device.

However, based on the Summary of Non-Clinical Testing section and the Clinical Testing section, I can extract some relevant information and identify what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information/Not Provided in the Document:

• Specific quantitative values for "product specification and performance requirements" for most non-clinical tests (e.g., what was the acceptance range for flow rate, peak pressure reduction, etc.?).
• The exact "pre-specified level of statistical significance" for the clinical study's primary endpoint.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated for either non-clinical or clinical testing.
  • For the non-clinical tests, it simply states "All testing passed."
  • For the clinical study, it's described as a "prospective, randomized, multi-center clinical evaluation," but the number of patients/cases is not provided.
• Data Provenance:
  • Non-Clinical: Performed by Osprey Medical or contracted labs. Location not specified, but likely within the US given the FDA submission.
  • Clinical: "Prospective, randomized, multi-center clinical evaluation." The country of origin is not specified, but multi-center implies multiple locations.

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

• Non-Clinical: Not applicable in the same way as imaging studies. Acceptance criteria were likely based on engineering specifications and regulatory standards.
• Clinical: The document mentions "maintaining adequate image quality" in relation to the clinical study. However, it does not specify how many experts assessed image quality, their qualifications, or how a "ground truth" for image diagnostic adequacy was established for the clinical images.

4. Adjudication Method for the Test Set

• Non-Clinical: Not applicable. Testing results either met criteria or did not.
• Clinical: No information is provided regarding an adjudication method for image quality or clinical outcomes in the clinical trial.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or reported.
  • The clinical study was a comparison of the AVERT system (with standard therapy) versus standard therapy alone (peri-procedural hydration), focusing on contrast volume reduction and safety, not on human reader performance or AI assistance. The device is a physical system to modulate contrast delivery, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, implicitly. The non-clinical Device performance testing (flow rate, pressure reduction, contrast diversion, etc.) and Simulated use (animal) testing represent standalone performance of the device's mechanical and fluidic functions. The device itself is a mechanical system, not an AI algorithm.
• The clinical study evaluates the device's effect in a human-in-the-loop scenario (physician using the device), comparing overall outcomes against standard care.

7. Type of Ground Truth Used

• Non-Clinical:
  • Engineering Specifications: For flow rates, pressure, cycle testing, etc.
  • Regulatory Standards: For sterility (ISO 11135-1:2007) and biocompatibility (ISO 10993-1:2009).
• Clinical:
  • Measured Contrast Volume: Objective quantitative measurement.
  • Clinical Observations/Outcomes: For device-related adverse events.
  • Clinical Assessment of Image Quality: This is described qualitatively as "adequate image quality," but the specifics of its establishment are not detailed.

8. Sample Size for the Training Set

• Not applicable/Not mentioned. The AVERT system is a mechanical device, not an AI algorithm that requires a training set. The term "training set" is typically used for machine learning models.

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

• Not applicable. As above, this is not an AI device.

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The DyeVert™ Contrast Modulation System is to be used for the controlled infusion of radiopague contrast media for angiographic procedures with the following agents: Iodixanol 320 mg/mL and Iopanidol 370 mg/l mL.

The Osprey Medical DyeVert™ Contrast Modulation System (DyeVert System) allows for manual, physician-modulated contrast media injection during coronary or peripheral angiographic imaging. The Dyevert System consists of a sterile, single-use, fully-disposable apparatus which provides a secondary fluid (contrast) pathway with a flow resistance feature to divert and store a portion of contrast in the reservoir chamber away from the patient. The source contrast container is connected to the reservoir chamber which has one tube directing contrast (through the manifold) to refill the injection syringe upon aspiration with preference to the diverted contrast volume prior to aspiration from the contrast source.

The provided text describes a 510(k) premarket notification for the DyeVert™ Contrast Modulation System. This application is for a medical device that aims to modulate contrast media injection, not an AI or imaging device, therefore many of the typical AI/ML acceptance criteria sections are not applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with specific quantitative thresholds alongside reported device performance for each criterion. Instead, it states that "All testing passed and demonstrated product performance met all prior established acceptance criteria." This general statement is common for medical device submissions where the specific metrics are typically internal company documents.

However, based on the text, we can infer the types of performance criteria tested:

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

The document does not specify sample sizes for any of the bench tests mentioned. It only states that "Bench testing was performed."

Data Provenance: The data provenance is from "Bench testing" and "Simulated Use (Cath Lab) and Design Validation," indicating in-vitro and simulated environment testing. There is no mention of country of origin for this testing, nor is it categorized as retrospective or prospective since it is not clinical data.

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

The document does not mention the use of experts to establish "ground truth" for the test set. The testing described (flow rate, pressure, leak, mechanical cycle, sterilization, packaging, biocompatibility) are objective, engineering, and laboratory-based tests that do not typically require expert interpretation for ground truth establishment in the way an AI/ML diagnostic device would.

For "Simulated Use (Cath Lab) and Design Validation," it mentions an "assessment of the ease of use, system set up and device priming ability (usability)." While this implies involvement of individuals who would typically use such a device (e.g., cath lab personnel or physicians), their number, specific qualifications, or their role in establishing "ground truth" (as in expert consensus for a diagnostic finding) are not detailed.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective bench or lab tests, not subjective interpretations requiring adjudication.

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/ML device, and no MRMC study was performed. The device is a mechanical system for modulating contrast media.

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

Not applicable. This is not an AI/ML device with an algorithm. It is a mechanical device that is operated by a human.

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

For the various bench and lab tests, the "ground truth" would be established by predefined engineering specifications, standardized testing protocols (e.g., ISO, ASTM standards), and objective measurements. For simulated use/usability, it would likely be based on pre-defined functional requirements and user feedback. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth, as these are typically associated with diagnostic or therapeutic devices where clinical outcomes or interpretations are central.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for 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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