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The FlexTip™ Grasper is a manual instrument intended for use in tissue grasping, dissecting and cutting in surgical or endoscopic sinus procedures and arthroscopic orthopedic and microdiscectomy surgery.

The Endius Incorporated FlexTip™ Grasper is composed of:

• · a tissue engaging tip of either a through cut or biting design
• · a series of nested high density polycarbonate vertebra joints which allow articulation of the grasper tip
• a shaft section which connects the flexible end to the handle .
• · a radius control sheath used to control the radius of curvature of the flexible tip
• · a pistol grip handle containing the control mechanism for the grasper tip.

The provided text is a 510(k) summary for the FlexTip™ Grasper, which is a manual surgical instrument. It describes the device, its intended use, and its technological characteristics compared to predicate devices. However, the document does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and a study from the provided text. The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory approval, rather than presenting a performance study against specific acceptance criteria.

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