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The Osprey Medical AVERT Contrast Modulation System is intended to be used for the controlled infusion of radiopaque Iodixanol 270 mg/ml contrast media for angiographic procedures.

The Osprey Medical AVERT Contrast Modulation System (AVERT System) consists of a Linear Slide Apparatus, Pressure Dampening Plates, and a Wheeled Stand. The nonsterile, reusable stainless steel dampening plates are attached to a non-sterile, reusable aluminum linear slide, positioned above a 6 cc syringe. The plates apply a constant force (using gravity) on the 6 cc syringe plunger acting as pressure dampener. The number of plates can be changed depending on the injection requirements. The Linear Slide Apparatus is attached to the Wheeled Stand, near the patient outside of the sterile field. The AVERT System is used in conjunction with standard disposable, sterile, off-the-shelf items including a 6 cc syringe, a 4-way stopcock, and an extension line that are provided in a Convenience Kit with the system (CK-100).

Here's a breakdown of the acceptance criteria and study information for the Osprey Medical AVERT Contrast Modulation System, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document states that "All test results demonstrated the materials, manufacturing processes, and design of the Osprey Medical AVERT System met the established performance criteria, will perform as intended and in a manner that is substantially equivalent to the predicated devices cited."

Study Information

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

   • Sample Size: Not explicitly stated. The document refers to "in vitro bench testing" and "all test results."
   • Data Provenance: In vitro bench testing. The country of origin is not specified but is implicitly the location of Osprey Medical (Minnetonka, MN, USA). The study was prospective as it involved newly conducted bench tests.

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

   • Not applicable. This device underwent in vitro bench testing, not clinical studies requiring expert ground truth for patient data.

3. Adjudication Method for the Test Set:

   • Not applicable for in vitro bench testing. Performance criteria were likely measured against predefined engineering specifications.

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

   • No. An MRMC study was not conducted as this was in vitro (bench) testing, not a clinical study involving human readers or cases.

5. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

   • Yes, in spirit. The performance tests described (Flow Rate, Peak Pressure Reduction, etc.) assess the device's inherent mechanical and fluid dynamics performance in a controlled environment, without direct human intervention in the 'reading' or interpretation of results beyond setting up and running the tests. It's not an "algorithm" in the typical software sense, but rather the standalone function of the hardware.

6. Type of Ground Truth Used:

   • Pre-established engineering specifications and performance criteria. The bench tests measured objective physical parameters (flow rate, pressure, etc.) against known or desired values for safe and effective operation, and for comparison to predicate devices.

7. Sample Size for the Training Set:

   • Not applicable. This is a mechanical device, not an AI/machine learning algorithm that requires a "training set" of data in the conventional sense. The "training" for the device's design and manufacturing would come from engineering principles, predicate device analysis, and iterative design/testing.

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

   • Not applicable for a mechanical device. The "ground truth" for its design and manufacturing would be based on established engineering standards, regulatory requirements, and the functional characteristics of the predicate devices it aims to be substantially equivalent to.

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