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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... <1%". However, these are reported results, not pre-defined acceptance criteria presented in a table format.

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

• Test Set Sample Size: "For the sample size of 147 patients (treatment group)". It also mentions "control group" but doesn't explicitly state its size.
• Data Provenance: "A prospective, randomized, multi-center clinical evaluation was conducted using the Osprey Medical AVERT™ Contrast Modulation System."
• Country of Origin: Not specified in the provided text.

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)

• Missing. The document mentions "maintaining adequate image quality" and "adeqate opacity," but does not explicitly describe how image quality was assessed (e.g., by experts, automated systems) or the number/qualifications of any such experts.

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

• Missing. No information on adjudication methods for image quality, adverse events, or any other outcome is provided.

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 / Missing. This device is a physical system for modulating contrast, not an AI or imaging diagnostic tool that would typically involve a multi-reader multi-case study for human reader improvement with AI. The document notes that "one incident recorded as poor image quality related to the treatment device that resulted in the system being 'shut off'," but this is not about human reader performance with AI assistance.

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

• Not Applicable. This is a physical device, not a software algorithm. Its performance is inherent in its mechanical function.

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

• Contrast Volume Reduction: Measured directly as the primary effectiveness endpoint. This is an objective measurement.
• Image Quality: Assessed to be "adequate" with a "low prevalence (<1%)" of poor image quality. The methodology for this assessment (e.g., expert review, objective metrics) is not detailed, so the "ground truth" method for image quality is unclear.
• Adverse Events: Clinical outcomes data derived from the study.

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI model requiring a training set in the typical sense. The "training" would refer to manufacturing and validation processes, not data to train an algorithm.

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

• Not Applicable. See point 8.

Summary of available information regarding the clinical study (leverage from the AVERT™ System):

• Study Type: Prospective, randomized, multi-center clinical evaluation.
• Device Studied: Osprey Medical AVERT™ Contrast Modulation System (clinical data leveraged for DyeVert due to high-level similarities and bench testing).
• Participants: Male and female subjects 18 years and older who were candidates for therapeutic percutaneous coronary intervention (PCI) procedures with documented chronic kidney disease.
• Primary Effectiveness Endpoint: Demonstrate a mean reduction of contrast volume in the treatment group compared to the standard of care control group.
• Results:
  • Mean reduction of 15.4% with a t-test p-value of 0.0229.
  • 15.0% relative reduction of contrast volume between treatment and control groups.
  • Diagnostic angiographic procedures demonstrated a 20.6% relative reduction.
  • PCI angiographic procedures demonstrated a 17.2% relative reduction.
  • One incident of poor image quality related to the device (<1%).
  • No reported device-related or unanticipated adverse events.

To fulfill your request completely, you would need a source document directly detailing the clinical trial, including its protocol, statistical analysis plan, and detailed results, which is beyond what is provided in this 510(k) summary.

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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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