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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 AVERT™ Contrast Modulation System is intended for the controlled infusion of radiopaque contrast media for angiographic procedures.

The AVERT™ Contrast Modulation System is to be used for the controlled infusion of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mg/mL, Iohexol 300 or 350 mg1/mL, Iopamidol 300 or 370 mg1/mL and Ioxilan 350mg1/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 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 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 is a 510(k) Summary for the AVERT Contrast Modulation System. It describes the device, its intended use, and indicates that no clinical testing was performed to support this specific Special 510(k) Premarket Notification. Instead, it relies on bench testing, leveraged predicate data, and a statement of equivalence to a previously cleared predicate device (K140425 and K150485).

Therefore, based on the provided document, the following answers can be given:

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

The document provides a summary of non-clinical testing and states that all tests passed and demonstrated product performance met all prior established acceptance criteria. However, the specific quantitative acceptance criteria values are not detailed in this summary. Instead, it lists categories of testing:

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

The document explicitly states: "No clinical testing was performed to support this Special 510(k) Premarket Notification." The testing performed was non-clinical (bench testing, simulated use, etc.), and much of it was leveraged from the predicate device. Therefore, there isn't a "test set" in the sense of a clinical patient cohort. The data provenance is from the previously conducted non-clinical and simulated use studies for the predicate device, but specific details on data origin are not in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical testing was performed and therefore no clinical ground truth was established by experts for a test set in this submission.

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

Not applicable, as no clinical testing was performed and therefore no adjudication was done for a clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a mechanical system (Contrast Modulation System) for controlled infusion of contrast media, not an AI or imaging device that would involve human readers interpreting images with or without AI assistance.

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

Not applicable. This is not an algorithm-based device.

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

For the non-clinical testing, the "ground truth" was established by product specifications and performance requirements validated through various bench tests (e.g., flow rate measurements, pressure reduction measurements, sterilization validation, biocompatibility analysis against ISO standards). For the simulated use (animal), the "ground truth" would be the observed physical parameters and image quality in animal models. The document indicates that all these tests met established acceptance criteria, effectively serving as the "ground truth" for non-clinical performance.

8. The sample size for the training set

The document does not describe a "training set" in the context of an AI/machine learning model. The device's validation relies on engineering specifications and physical test performance, not a data-driven training approach.

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

Not applicable, as there is no training set in the context of AI/machine learning. The "ground truth" for the device's development and validation would have been its design specifications and the results of various engineering and biocompatibility tests.

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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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