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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 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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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 mg/ml, Iohexol 300 or 350 mg1/ml, and Iopamidol 370 mg[/ml.

Similar to the first generation AVERT Contrast Modulation System (weighted), the Osprey Medical second generation AVERT Contrast Modulation System consists of a reusable, non-sterile apparatus (contrast modulator or RMS), which applies a force to a disposable modulation reservoir. The system also includes a wheeled stand for which to mount the RMS. The RMS applies a force directly to the single use sterile, detachable modulation reservoir, which has a pressure dampening effect during contrast delivery, similar to the weighted AVERT System. The RMS utilizes an internal mechanism to apply force to the modulation reservoir. 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 RMS is attached to the wheeled stand and is positioned near the patient, outside of the sterile field. The disposable components of the AVERT Contrast Modulation System include a modulation reservoir, which is connected to a standard, off-the-shelf 4-way stopcock and extension line that are all provided sterile.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it refers to general performance categories and states that the device "met the established performance criteria."

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

• Test Set Sample Size: The document does not specify a numerical sample size for the test set used in the in vitro bench testing. It only states that "All test results demonstrated..."
• Data Provenance: The testing was "in vitro bench testing." The document does not mention the country of origin for the data or whether it was retrospective or prospective.

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

Not applicable. The study involved in vitro bench testing, not human expert evaluations of medical images or conditions to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. The study involved in vitro bench testing, so there was no adjudication method for a test set based on expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is an Angiographic Injector, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. This is a medical device (Angiographic Injector), not an AI algorithm. The performance evaluation was based on the device's physical and mechanical properties.

7. The Type of Ground Truth Used

The "ground truth" for the in vitro bench testing was the "established performance criteria" for the device's mechanical and functional characteristics (e.g., flow rate, peak pressure reduction, adjustability, mechanical cycles, sterility). This is based on engineering and manufacturing standards rather than medical ground truth like pathology or expert consensus.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning model, so there is no concept of a "training set."

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

Not applicable. Refer to point 8.

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