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The Spiral Flow Peripheral Vascular Grafts are indicated for use as vascular prostheses.

The device is intended for use in the bypass or reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee. Graft configurations are intended for use as arterial conduits for bypass, or reconstruction of peripheral arterial blood vessels.

ONLY trained and qualified physicians and/or surgeons, under the controlled conditions of a hospital operating theatre environment are indicated for use of this device for implantation.

Vascular Flow Technologies' (VFT) Spiral Flow™ Peripheral Vascular Graft is to be used in the bypass or reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee; it has a specially designed section to induce spiral laminar flow.

The unique design feature translates Spiral Laminar Flow (SLF™) technology to the graft lumen profile. SLF™ technology is designed to propagate spiral flow though the graft and into the distal circulation.

The starting material for the VFT Spiral Flow™ Peripheral Vascular Graft is a straight tubular vascular graft made from expanded polytetrafluoroethylene (ePTFE).

The graft includes a helical overlay of polytetrafluoroethylene (PTFE) beading over most of the grafts length. This is heat set onto the external surface of the ePTFE tube. The function of the beading is to provide reinforcement for the tube.

The unique SLF™ spiral flow inducer is injection molded onto the outer surface of the straight graft. The inducer and indicator are made from ChronoFlex® C-80A; a Biodurable Medical Grade polyurethane

The provided text does not describe an AI medical device or a study proving its performance. Instead, it is an FDA 510(k) clearance letter and summary for a Spiral Flow Peripheral Vascular Graft, which is a physical vascular prosthesis.

Therefore, I cannot provide the requested information about acceptance criteria and a study for an AI device. The document is about a Class II medical device (a vascular graft) and its substantial equivalence to a predicate device based on non-clinical tests, not an AI algorithm.

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