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The Crux Vena Cava Filter (VCF) System is indicated for the prevention of recurrent pulmonary embolism via placement in the inferior vena cava (IVC) in the following situations:

• pulmonary thromboembolism when anticoagulants are contraindicated:
• failure of anticoagulant therapy in thromboembolic disease;
• emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced;
• chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

The Crux VCF may be removed according to the instructions contained in the section "Optional Retrieval of the Crux VCF" in patients who no longer require a vena cava filter. Retrieval of the filter can be performed by femoral or jugular approach.

The Crux Vena Cava Filter (VCF) System is an endovascular medical device used in the prevention of recurrent pulmonary embolism (PE). The system is comprised of a self-expanding Nitinol filter delivered from a single-use, disposable 9Fr catheter, which can be used percutaneously to deploy the filter. The filter wireforms are composed of two opposing selfexpanding Nitinol spiral elements connected at each end with Nitinol crimps. One of each wireform is formed into a sinusoidal shaped retrieval tail to aid in retrieval of the filter using a snare. Each retrieval tail has an atraumatic plasma ball and a radiopaque tantalum marker band to facilitate visualization. There are five tissue anchors attached to the wireform elements with Nitinol tubing. The filter is designed to treat IVC diameters of 17 to 28mm.

The delivery catheter for the Crux VCF System is a disposable, 9Fr introducer-sheath-compatible, single-use delivery catheter. The filter is provided loaded in the Crux VCF System for jugular or femoral approach delivery. The delivery catheter is an over-the-wire system, 0.035" guidewirecompatible, and is comprised of a polycarbonate inner shaft and a nylon outer shaft. The polyimide inner shaft is comprised of the guidewire lumen, and a flexible radiopaque tracking tip with a radiopaque marker band. The outer shaft has a radiopaque marker band, a Touhy-Borst hemostasis valve, and a one-way check-valve for flushing.

The filter can be retrieved with commercially available snares and sheaths via either the jugular or femoral approach.

The provided text describes a 510(k) premarket notification for the Crux Vena Cava Filter System. The document focuses on regulatory approval based on substantial equivalence to a predicate device and addresses labeling changes, not on a study proving the device meets specific acceptance criteria in terms of clinical performance as an AI/CAD/imaging device.

Therefore, many of the requested details, such as a table of accuracy metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types related to AI/CAD/imaging device performance, are not applicable to this submission.

However, the document does mention performance data related to device functionality.

Here's the information that can be extracted or deduced from the provided text:

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

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated. The "tests" mentioned were bench and animal studies, not human clinical trials for endpoint efficacy.
• Data Provenance: Not explicitly stated. The studies were described as "bench and animal device testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. The "tests" focused on device functionality (e.g., flow, radial force, pressure integrity, workflow) rather than clinical diagnostic or therapeutic outcomes requiring expert ground truth for interpretation.

4. Adjudication method for the test set:

• Not Applicable. This is not relevant for the type of device functionality tests described.

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. This is not an AI/CAD/imaging device.

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

• Not Applicable. This is not an AI/CAD/imaging device.

7. The type of ground truth used:

• For the bench testing, the "ground truth" would be established by validated engineering principles, physical measurements, and computational models (e.g., CFD).
• For the animal testing, the "ground truth" would be direct observation and measurement in the animal model.
• Not pathology, outcomes data, or expert consensus in the context of diagnostic interpretation, as this is a device for mechanical intervention.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning or AI device that requires "training sets."

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

• Not Applicable. This is not a machine learning or AI device.

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