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The WOLF Thrombectomy V System is indicated for the nonsurgical removal and thrombi from arterial and venous blood vessels in the peripheral vasculature.

The WOLF Thrombectomy V System is comprised of two single lumen composite, variable stiffness catheters. Both devices have a distal radiopague marker for recognition under fluoroscopy. The WOLF Outer device has a collapsible braided funnel formed at its distal end. The purpose of the funnel is to enable more efficient ingestion of clot in larger vessels. The system includes a preloaded weave and additional reloadable weave and reloadable weave are fabricated from fine nitinol wire formed into a desirable tubular shape and attached to the WOLF Inner Catheter. The end of both weaves that are not attached to the WOLF Inner Catheter are cuffed with a radiopaque polymer. The WOLF outer catheter has hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot. The WOLF inner catheter has one radiopaque marker band at the distal marker to indicate the tip of the catheter during tracking. The outer catheter has two sets of radiopague markers. The distal most marker bands reside in the distal end of the funnel to facilitate visualization of the second marker band is located at the base of the funnel to aid in positioning the funnel relative to the sheath during clot ingestion. The reloadable weaves can be used for additional clot removal. A WOLF Thrombectomy V System used with a reloadable weave has the same principle of operation of action as the system packaged with the preloaded weave.

The provided document is an FDA 510(k) clearance letter for the WOLF Thrombectomy V System. While it refers to performance data and animal testing, it does not contain the detailed information necessary to complete a table of acceptance criteria, specific reported performance metrics, or the methodologies for establishing ground truth for AI/ML device studies (e.g., number of experts, adjudication methods) as requested.

The document discusses:

• Device Description: The WOLF Thrombectomy V System is an embolectomy catheter for nonsurgical removal of emboli and thrombi from peripheral arterial and venous blood vessels.
• Substantial Equivalence: The submission demonstrates substantial equivalence to a predicate device (WOLF Thrombectomy Device, K182835) based on similar intended use, mechanism of action, components, construction, materials, and sterilization. It also used a reference device (Fogarty Venous Thrombectomy Catheter).
• Performance Data: States that bench studies indicate the device performs as intended and lists various types of testing performed (e.g., durability, sterility, shelf life, biocompatibility, simulated use, comparative performance analysis, animal testing).
• Animal Testing: Mentions acute and chronic animal studies were conducted to compare the safety of the WOLF device to a control device, assessing angiographic and histopathological outcomes. It states "The device passed all acceptance criteria outlined in the study protocol and should be deemed acceptable for clinical use," but does not specify those criteria or numerical results.

Essentially, this document summarizes that certain tests were done and passed, but it does not provide the specific details of those tests' acceptance criteria or the numerical results, nor does it describe a study involving an AI/ML component with human readers, training sets, or expert ground truth as typically required for AI/ML device clearances.

Therefore, I cannot populate the requested table and answer many of the questions because the information is not present in the provided text. The prompt asks for details related to an AI/ML device study, but the provided text describes a mechanical medical device (thrombectomy catheter) and its traditional 510(k) clearance process, which focuses on bench testing and animal studies for safety and performance of the physical device, not an AI/ML algorithm's analytical or clinical performance characteristics against a defined ground truth derived from expert consensus or pathology.

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