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The Orthodontic Bone Anchor (OBA) System is intended to be implanted intraorally and used as an anchor for orthodontic procedures.

The Synthes (USA) Orthodontic Bone Anchor System is a plate and screw system designed to be implanted intraorally and used as an anchor for orthodontic procedures. The plate anchor portion of the system consists of T-shaped plate anchors which are attached to the bone via 1.55 mm cortex screws and 1.85 mm emergency screws. The plate anchors are offered in various designs for attachment to the orthodontic device. The screw anchor portion of the system consists of 1.55 mm self-drilling and self-tapping screw anchors which incorporate a non-threaded gingival collar beneath the screw head which protects the soft tissue.

I am sorry, but the provided text does not contain information regarding the acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) summary and FDA clearance letter for the Synthes Orthodontic Bone Anchor System, which focuses on device description, intended use, classification, and substantial equivalence to predicate devices. It does not include data from a clinical or performance study that would typically establish acceptance criteria and verify device performance against those criteria.

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