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The Cordis TrapEase™ Permanent Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in the following situations: pulmonary thromboembolism when anticoagulants are contraindicated, failure of anticoagulant therapy in thromboembolic diseases, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

The VisEase Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to the vena cava.

The subject TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator most notably differs from the predicate TrapEase Permanent Vena Cava Filter and Introduction Kit with regards to the vessel dilator that is included as a component in the Introduction Kit. In addition to its original function as a vessel dilator, which was featured with the predicate Cordis TrapEase Introduction Kits, the subject VisEase Angiographic Vessel Dilator features new intended uses involving angiographic visualization and linear measurement. These new intended uses of the subject VisEase Angiographic Vessel Dilator are addressed in updated product labeling herein and are identical to the intended uses of the predicate Cordis Super Torque MB Angiographic Catheter (reference K992347, determined substantially equivalent on October 8, 1999). Besides the aforementioned changes in intended use for the VisEase Angiographic Vessel Dilator, the TrapEase Permanent Vena Cava Filter and all other components used with the subject device remain unchanged from #K000062, #K003964 and #K010083).

The provided document is a 510(k) premarket notification for the "Cordis TRAPEASE™ Permanent Vena Cava Filter with the VISEASE™ Angiographic Vessel Dilator." This type of submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and device performance metrics in the way a clinical trial or AI device might.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not typically found in this type of regulatory submission because they are not required to demonstrate substantial equivalence for this conventional medical device.

However, I can extract the information that is present and indicate what is not applicable based on the document.

1. A table of acceptance criteria and the reported device performance

For this device, "acceptance criteria" are primarily related to conforming to established standards and demonstrating functional performance through non-clinical testing. The document states that the safety and effectiveness were demonstrated through "non-clinical design verification tests and analyses."

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

This information is not provided in the document as it's a 510(k) summary relying on non-clinical engineering and bench testing, not human subject data for "test sets" in the typical sense. Data provenance is not specified for the non-clinical tests.

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)

This information is not applicable for this type of submission, as ground truth is not established by human experts for non-clinical bench testing.

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

This information is not applicable for this type of submission.

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

An MRMC study is not applicable to this device, as it is a physical medical device (vena cava filter and dilator), not an AI diagnostic tool or system that assists human readers.

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

This is not applicable as the device is a physical medical device, not an algorithm.

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

Given that the testing consisted of "non-clinical design verification tests and analyses" (Visual and Dimensional Inspection, Catheter Sheath Introducer Compatibility, Flow Rate Testing, Hydrodynamic Testing, Pull Strength Testing), the "ground truth" would be established by engineering specifications, material science standards, and performance metrics defined for the device during its design and development, rather than medical ground truths like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable as this is a physical medical device and not an AI algorithm requiring a training set.

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

This information is not applicable as this is a physical medical device and not an AI algorithm.

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