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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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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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