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The product has been designed for retrieval of implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.

The Günther Tulip Vena Cava Filter Retrieval Set is composed of a retrieval loop system with a braided platinum wire loop, a coaxial retrieval sheath system, an entry needle, a wire guide, and a dilator. The outer sheath is provided with a radiopaque band on the distal tip to assist in positioning of the sheath. The Günther Tulip Vena Cava Filter Retrieval Set is intended to retrieve the implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter.

The Günther Tulip Vena Cava Filter Retrieval Set is a packaged, sterile device intended for single use.

The provided document is a 510(k) premarket notification for a medical device called the "Günther Tulip Vena Cava Filter Retrieval Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study for a specific performance claim (e.g., diagnostic accuracy for an AI device).

The document states that modifications were made to the predicate device, specifically a change in the dilator material and a change in the o-ring material. To demonstrate that these changes do not negatively impact safety and effectiveness, the manufacturer performed non-clinical performance tests.

Therefore, the information requested in your prompt regarding acceptance criteria, study design parameters (sample size, experts, ground truth, MRMC study, standalone performance), and training set details are not applicable (N/A) in the context of this specific 510(k) submission for a mechanical medical device. These types of details are typically required for AI/ML-based medical devices or devices making specific claims about diagnostic or predictive performance.

Here's a breakdown of the requested information based on the provided document:

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

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

N/A - This document describes non-clinical performance testing (biocompatibility, dimensional, leakage, tensile) of a mechanical device. There is no "test set" in the context of patient data, nor is there data provenance as would be relevant for clinical studies or AI/ML evaluation. These were laboratory-based physical 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)

N/A - No human expert "ground truth" was established as this was non-clinical performance testing of a mechanical device.

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

N/A - Adjudication methods are not applicable to the non-clinical performance testing 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

N/A - This device is a mechanical Vena Cava Filter Retrieval Set, not an AI-based system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

N/A - This is a mechanical device, not an algorithm.

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

N/A - For the non-clinical tests, the "ground truth" would be the engineering specifications and recognized standards (e.g., ISO 10993 for biocompatibility) against which the device's physical performance was measured. There is no biological or outcome-based ground truth mentioned.

8. The sample size for the training set

N/A - No "training set" is relevant for this type of mechanical device submission.

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

N/A - See point 8.

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The Cook Celect™ Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:

• Pulmonary thromboembolism when anticoagulant therapy is contraindicated; .
• Failure of anticoagulant therapy in thromboembolic diseases; .
• Emergency treatment following massive pulmonary embolism when anticipated . benefits of conventional therapy are reduced; and
• Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is . contraindicated.

The filter may be retrieved according to the instructions supplied in the section labeled "Optional Retrieval Procedure."

The Günther Tulip™ Vena Cava Filter Retrieval Set has been designed for retrieval of implanted Günther Tulip™ and Cook Celect™ Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.

The Cook Celect Vena Cava Filter is an inferior vena cava filter intended for use in prevention of pulmonary embolism. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of inferior vena cava (IVC) blood. The Cook Celect Vena Cava Filter is constructed from a biocompatible alloy. The filter is 48 mm long along its main axis when compressed to a diameter of 30 mm. The design of the Cook Celect Vena Cava Filter allows the filter to anchor to the vena cava walls by means of the hooks at the ends of the primary legs.

The Günther Tulip Vena Cava Filter Retrieval Set consists of a retrieval loop system with a braided platinum wire loop, a coaxial retrieval sheath system, an entry needle, a wire guide, and a dilator. The outer sheath is provided with a radiopaque band on the distal tip for assisting in positioning of the sheath.

Acceptance Criteria and Study for Cook Celect™ Vena Cava Filter and Günther Tulip™ Vena Cava Filter Retrieval Set

This submission (K073374) is for an expansion in the indications for use for the Cook Celect™ Vena Cava Filter and Günther Tulip™ Vena Cava Filter Retrieval Set, specifically to include the retrievability of the Celect filter.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 43 patients.
• Data Provenance: Not explicitly stated whether the study was retrospective or prospective, or the country of origin. However, the context of a 510(k) submission for an expanded indication typically relies on prospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text. The study focuses on retrieval success, which is a clear clinical outcome rather than an interpretation requiring adjudication in the same way as an imaging study might.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study was a clinical study demonstrating the retrievability of the device, not an assessment of human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. The device described is a physical medical device (vena cava filter and retrieval set), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth was established by clinical outcomes: whether the Cook Celect™ Vena Cava Filter was successfully retrieved from patients using the Günther Tulip™ Vena Cava Filter Retrieval Set.

8. The Sample Size for the Training Set

Not Applicable. As this is a physical medical device, there is no "training set" in the context of an algorithm or AI system. The "training" for the device would be its design, manufacturing, and preclinical testing, which are supported by the "bench testing" mentioned.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. (See #8). The product's development and verification would involve standard engineering and medical device testing methodologies. The submission explicitly states "bench testing on the devices demonstrating that the Celect filter can be retrieved" as a basis for the expanded indication.

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