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The AKónya Eliminator Plus™ Mechanical Thrombectomy Device is indicated for use in the mechanical declotting native arterio-venous (AV) fistula and synthetic dialysis grafts.

The AKónya Eliminator Plus™ Mechanical Thrombectomy Device is comprised of three discrete elements:

• . An outer member, connected distally to the proximal end of the thrombasket. The proximal end is connected to a hemostasis Y-connector, having a side port for flushing, and a Tuohy-Borst connector on the central port for securing to hypotube, as an aid for handling during the surgical procedure.
• 트 An inner member, connected distally to the distal cnd of the thrombasket. Proximally, the inner member is connected to a handle.
• 트 A thrombasket, composed of woven or braided stainless steel wire.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The documents are FDA 510(k) clearance letters for the Akonya Eliminator Plus Mechanical Thrombectomy Device. They establish substantial equivalence to predicate devices and outline the indications for use. While they mention "pre-clinical animal data presented in the performance section of this 510(k) submission" as the basis for an expanded indication, the details of this data, including the specific criteria and results you've asked for, are not included in these documents.

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