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The Flexposure Retractor is a manual surgical instrument intended to provide endoscopic access to the posterior lumbar spine by retracting tissues during endoscopic discectomy procedures.

The Flexposure Retractor is a manual surgical instrument intended for use in posterior endoscopic microdiscectomy procedures. It is essentially a standard retractor designed to improve exposure of the surgical site. The Flexposure Retractor looks like a standard retractor/tube like device with the exception of the distal end. The distal end of the device can expand to better retract tissues from the operative site. The device includes a tip release line which is attached to an outer heat shrink polyester material. The purpose of the heat shrink polyester material is to maintain the retractor in the closed position. The remainder of the device is made from medical grade stainless steel. The Flexposure Retractor is placed several centimeters lateral to the midline of the back through a cannula. The tip of the Retractor is positioned on the lamina. After positioning, the user pulls the tip release line which causes the heat shrink polyester material to split. The splitting of the heat shrink material allows for the expansion of the tip of the cannula. A mechanical hand held retractor is inserted through the cannula and opened causing the flexible stainless steel skirt of the retractor to be expanded to approximately a 25 mm dimension.

This document is a 510(k) summary for the Endius Incorporated Flexposure Retractor. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence for regulatory clearance rather than presenting performance metrics against predefined acceptance criteria.

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