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The Texan™ Foreign Body Retrieval Device is indicated for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system.

The Texan™ is comprised of the following:

• A nitinol wire formed into a loop. The wire is secured distally to the catheter body; the proximal wire end is attached to a shaft that functions as a push-rod, and passes through a dedicated catheter lumen. The "loop" portion of the wire has a radiopaque feature, comprised of Nitinol wire with a platinum core and tungsten sheath
• A two-lumen catheter body. One lumen is dedicated for use by the loop wire, which is secured to the push-rod (shaft) at the proximal end of the loop wire. The second and larger lumen is dedicated for use of a guidewire and contrast. The proximal catheter end is to be attached to a hemostasis valve with a flush port.
• The hemostasis valve has 2 ports:
• side port having access to the guidewire-dedicated lumen for contrast injection; and
• primary port dedicated for a guidewire, and having a Tuohy-Borst connector.

The loop is activated by pushing the shaft distal to the Touhy-Borst connector while holding the Touhy-Borst stationary. The device should be manipulated in such a way that the loop can surround the foreign body. To capture the foreign body, the user shall slowly tighten the loop around the foreign body by pulling the shaft proximally while the device is held stationary in position. Once the loop is tightened around the foreign body the shaft shall be locked by rotating the homeostasis valve connected to the proximal end of the shaft clockwise. Retrieval of the foreign body is performed by slowly withdrawing the Texan™ and the foreign body as a unit into the sheath.

The provided text is a 510(k) summary for the Texan™ Foreign Body Retrieval Device. It primarily focuses on demonstrating substantial equivalence to a predicate device and details non-clinical performance testing. It does not contain information about acceptance criteria in the form of specific performance metrics or a study designed to prove the device meets these criteria in the context of clinical or comparative effectiveness.

Here’s a breakdown of the information that is and is not available:

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

This information is not present in the provided document in the format of specific, quantifiable acceptance criteria and corresponding reported device performance values. The document states that the device "successfully passed all functional and safety testing requirements to ensure substantial equivalence to the predicate device," but it does not list these requirements as specific acceptance criteria (e.g., success rate > X%, retrieval time < Y seconds) nor does it provide quantitative results.

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

No specific test set sample size is mentioned for any of the non-clinical tests or the animal study. The document does not specify the country of origin of data or whether tests were retrospective or prospective.

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 as there is no mention of a clinical test set requiring expert ground truth establishment. The document describes an "Animal Study" to evaluate safety and efficacy, but details about ground truth establishment or expert involvement are not provided.

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

This information is not applicable as there is no mention of a clinical test set 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:

This information is not present. The Texan™ device is a physical foreign body retrieval tool, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study or AI-assisted improvement metrics are irrelevant and not discussed.

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

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

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

For the "Animal Study," the ground truth implicitly would have been observed safety, efficacy, and operational characteristics of the device within the animal model, likely assessed through direct observation, imaging, and potentially post-mortem examination. However, specific details are not provided.

8. The sample size for the training set:

This information is not applicable as the device is a physical tool, not a machine learning algorithm that requires a training set.

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

This information is not applicable as the device is a physical tool, not a machine learning algorithm that requires a training set.

Summary of available information regarding studies and performance:

The document describes the following non-clinical performance testing:

• Accelerated Aging / Packaging: Determined effects of time & environment on device and packaging materials to substantiate a 1-year shelf life. Tests included package Seal Peel, Burst, Dye Penetration, and device functionality after aging.
• Packaging / Shipping Integrity: Determined possible adverse effects of shipping & transportation environments on survivability of device packaging and construction materials.
• Dimensional: Ensured the device met dimensional requirements as defined in the product specification.
• Tensile: Verified design meets minimum tensile strength requirements at all joints as defined in the product specification.
• Biocompatibility: Determined potential toxicity from component materials in contact with the body.
• Animal Study: Evaluated the safety and efficacy of the proposed device, and operational characteristics compared to a predicate device. This study was likely the most "clinical-like" evaluation, providing evidence for safety and a comparison of performance aspects in a living system.

The conclusion states that the "Texan™ Foreign Body Retrieval Device has successfully passed all functional and safety testing requirements to ensure substantial equivalence to the predicate device." However, specific numerical acceptance criteria or performance metrics are not given. The FDA's 510(k) clearance is based on this finding of substantial equivalence to the predicate device (ev3's Amplatz "Goose-Neck" Snare) based on design and technological characteristics, and confirmed by the non-clinical and animal studies.

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