Search Results

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.

Ask a specific question about this device