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The subject devices are intended to be placed in the mouth for use as an anchor in orthodontic procedures.

The Bollard Miniplate Skeletal Anchorage System provides a fixed anchorage point for the attachment of orthodontic appliances to facilitate orthodontic movement of teeth. Small stationary points connected to bone inside the mouth allow connection of wire, elastic, or other hardware.

The Bollard Miniplate Skeletal Anchorage System includes Commercially Pure Titanium miniplates fixed by miniscrews to the cortical bone. After insertion by the surgeon the miniplates are completely covered by soft tissue. The miniplates and miniscrews are sold sterile and are sterilized using Gamma Radiation per ISO 11137-1.

The bone anchor consists of a miniplate (M) with 2 or 3 holes, a round connecting bar (C), and a fixation unit (F) with a blocking screw (S). The miniplate is fixed to the bone by self-tapping or selfdrilling screws. The fixation unit contains 2 slots with a diameter of 0.045" (1.1mm). A square connecting wire with a maximum size of 0.032x0.032" can be inserted and tightly fixed by the blocking screw.

The Bollard miniplates are also offered with a hook. The Bollard with hook is smaller than the original model and contains a tube with section 0.020"x0.020". The hook can affix directly to elastics or coil springs.

The subject devices are used with standard instrumentation for orthodontic surgery including pliers, punches, screwdrivers, burrs, and grasping or holding instruments.

The provided text is a 510(k) Summary for the TITA-LINK Bollard Miniplate Skeletal Anchorage System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for a study of the device.

The document states: "The subject device is composed of well characterized and biocompatible material that meets applicable standards." and "We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device." This indicates that the approval was based on demonstrating substantial equivalence to a legally marketed predicate device, rather than through a de novo performance study with specific acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided text.

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