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The device consists of a manual syringe and display to be used during Angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

The Osprey Medical Contrast Monitoring System (CMS) allows for monitoring and display of manually injected contrast volumes. Volumes are displayed and compared to physician entered contrast usage thresholds during angiographic procedures.

The use of the system is intended to provide the user an easier way to measure cumulated volumes and support physician-determined minimization of contrast volumes. The additional benefit of the system is to allow for a visual and audible indication of when the cumulated volume injected into the patient is approaching a physician determined contrast volume threshold. This allows for attentive physician decision-making of total contrast volumes use during a patient case while allowing the physician's primary focus to remain on the image and the therapeutic need of imaging.

The provided document does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is primarily a 510(k) summary and an FDA clearance letter for a "Contrast Monitoring System."

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly presented in a table format with specific acceptance criteria and corresponding performance metrics for the device's main function (contrast monitoring accuracy). The provided text mentions "bench testing...demonstrates that the Contrast Monitoring System meets product specification, meets performance requirements and demonstrates substantial equivalence." It lists categories of tests performed (e.g., "accuracy testing of cumulative and individual injection volume measurement along with display verification"), but it does not provide the specific acceptance criteria for these tests (e.g., "accuracy must be within +/- X% of actual volume") nor the numerical results for the device's performance against those criteria.

2. Sample size used for the test set and the data provenance: Not specified for the core performance tests (e.g., accuracy of volume measurement). For "Simulated Use (Animal and Bench)," it states "Animal testing was conducted with swine model," but no sample size for the animals is given. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For the "Simulated Use (Animal and Bench)" which included animal testing, it mentions "conducted with swine model by three physicians." Their specific qualifications (e.g., years of experience, specialization) are not provided. For other performance tests like "accuracy testing of cumulative and individual injection volume measurement," the method for establishing ground truth and any expert involvement is not described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not specified based on the type of non-clinical testing described. The tests are primarily technical performance evaluations rather than image interpretation or diagnostic studies 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: No MRMC study was mentioned. The device is a 'Contrast Monitoring System' for manual injection with a display, not an AI-powered diagnostic imaging tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device involves a human operator (physician) manually injecting contrast while the device monitors and displays volumes. Therefore, a purely standalone algorithm evaluation without human interaction would not be directly relevant to its intended use and is not described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "accuracy testing of cumulative and individual injection volume measurement," the ground truth likely refers to precisely measured actual volumes of contrast injected, compared against the device's displayed measurements. However, the specific method for establishing this "ground truth" (e.g., by gravimetric analysis, calibrated syringes) is not detailed.

8. The sample size for the training set: Not applicable and not mentioned. The device is a monitoring system and does not appear to be an AI/machine learning device that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for an AI/ML model.

In summary, the provided document focuses on regulatory clearance by demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It lists categories of tests performed and states that "all testing passed," but it lacks the detailed quantitative acceptance criteria and specific performance outcomes you've requested for each criterion.

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