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The Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults.

The Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults.

The Synthes (USA) Orthodontic Bone Anchor System is intended to be implanted intraorally and used as an anchor for orthodontic procedures. The System includes screw anchors, plate anchors, instruments, and a module case for storage and sterilization.

Screw Anchors
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 to protect the soft tissue. Once implanted, orthodontic appliances such as archwires, elastics, and springs can be attached to the head of the anchor.

The screw anchors are manufactured from titanium alloy (Ti-6Al-7Nb).

Plate Anchors
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 three designs (mesh, bracket, and domed) to allow attachment of orthodontic devices such as brackets, archwires, elastics, and springs

The plate anchors are manufactured from commercially pure titanium. The screws used to fix the plate anchors to the bone are manufactured from titanium alloy (Ti-6Al-7Nb)

The provided text describes a 510(k) premarket notification for the Synthes Orthodontic Bone Anchor System. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a detailed study with specific performance metrics against those criteria.

Therefore, many of the requested sections (e.g., acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth information) cannot be extracted from this document as this type of information is generally not required or provided in a 510(k) summary for mechanical devices like bone anchors.

The document primarily states:

• Non-Clinical Testing Data: "The Synthes Orthodontic Bone Anchor System was tested for resistance to pullout under clinical loads by means of axial, shear, and cantilever loading. Screws were also tested for insertion torque, removal torque, and yield and failure torque."
• Substantial Equivalence: "The proposed devices are similar to the predicate devices identified above in terms of indications, principles of operation (provide fixed anchorage for orthodontic movement of teeth), device design/geometry, and materials. Information presented supports substantial equivalence."

This indicates that mechanical testing was performed, but specific acceptance criteria and the quantitative results validating against them are not detailed in the provided summary. The focus is on demonstrating that the new device performs similarly to existing, legally marketed devices.

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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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