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The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is regain or maintain adequate aneurysm exclusion.

The EndoAnchor may be implanted at the initial endograft placement, or during a secondary (i.e., repair) procedure.

The Heli-FXTM and Heli-FX Thoracic EndoAnchor™ Systems are each comprised of the respective Heli-FX Applier with EndoAnchor Cassette, containing ten EndoAnchor implants; the respective Heli-FX Guides, and the Ancillary EndoAnchor Cassette, containing five EndoAnchor implants.

The Heli-FX EndoAnchor System comprises the EndoAnchor implant, an intravascularly-applied suture, supplied with the Heli-FX Applier in a Cassette containing ten (10) EndoAnchor implants, or separately in an Ancillary Cassette containing five (5) EndoAnchor implants; the Heli-FX Applier, a catheter-based device for placement of the EndoAnchor; and the Heli-FX Guide, a deflectable sheath to position the Applier.

The EndoAnchor is an endovascularly-placed suture designed to attach aortic endografts to the native vessel wall. The EndoAnchor is manufactured from medical-grade nickel-cobalt wire and is wound in a helical shape. The leading end is sharpened to a conical point to act as an integral needle facilitating atraumatic deployment through the graft material and vessel wall. The proximal end of the EndoAnchor includes a diagonal crossbar, which functions as a suture anchor designed to prevent over penetration of the EndoAnchor. Ten (10) EndoAnchor impants are prepackaged into a cassette, which is supplied with the Heli-FX Applier. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter. EndoAnchor implants are also supplied separately in an Ancillary Cassette containing five (5) additional EndoAnchor implants.

The Heli-FX Applier is designed to implant the EndoAnchor. The Applier implants one EndoAnchor at a time, and can be used to implant multiple EndoAnchor implants in a single patient. The Applier is designed for use with the Heli-FX Guide. The Applier is a 12Fr (OD) catheter with an integrated control handle. Two Applier lengths are available for anchoring in different regions of the aorta.

The Heli-FX Guide is a sterile, single use, disposable device designed to direct the Heli-FX Applier to the desired location for EndoAnchor implantation. The device is compatible with a 0.035" Guide wire. The Heli-FX Guide consists of a 12 Fr-compatible (inner diameter) Guide sheath with integrated control handle, and a matching 12 Fr OD obturator. Deflection of the distal tip of the catheter is accomplished by rotating the Control Knob located on the control handle. The Guide is available in both 62cm (16Fr OD) and 90cm (18Fr OD) working lengths. Multiple deflectable tip lengths are available to accommodate a range of aortic diameters. The Obturator is used during vessel access and is designed to follow the Guide wire and provide access through tortuous vasculature.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details for the Heli-FX EndoAnchor System.

The document is a 510(k) premarket notification decision letter and a 510(k) summary. It primarily focuses on the substantial equivalence of the device to previously cleared predicate devices, particularly due to a change in the sterilization facility.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.

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