(88 days)
The Leibinger Burr Hole Covers are designed to be used with fixation screws to cover burr holes of various diameters in the craniofacial skeleton in order to provide good cosmetic results and protection of the underlying soft tissues and brain. This device can also be used to secure cranial bone flaps.
The Leibinger Two and Four-Hole Straight Plates are intended for fixation of small bones, including the craniofacial skeleton and midface bones, the fixation of facial bones following elective osteotomies and internal fixation of fractures of the hand.
The Leibinger Temporal Gap Plates are intended for use with patients requiring reconstruction of the cranial area, including the sub-temporal regions. These plates provide fixation and stabilization of cranial bone flaps.
The Burr Hole Cover has a segmented plate-like structure. These Burr Hole Covers are 0.5mm thick and are comprised of four different configurations.
The Titanium Two and Four-Hole Straight Plates are holed plates which are attached to bone using screw fixation. They are similar in design to the straight plates of the Wurzburg Titanium Mini Bone Plating System. These plates are 0.5mm thick.
The Titanium Temporal Gap Plates are holed plates which are attached to bone using screw fixation. The configurations vary to accommodate the level of reconstruction required for the patient's anatomy.
The provided text describes 510(k) submissions for several medical devices: "Burr Hole Covers", "Craniomaxillofacial Plates" (specifically "Two and Four-Hole Straight Plates"), and "Temporal Gap Plates". These are medical devices used for bone fixation and reconstruction, not AI/ML-driven diagnostic devices.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set details), which are typically relevant for AI/ML diagnostic device studies, cannot be found in the provided documents.
The documents focus on demonstrating "substantial equivalence" to predicate devices based on intended use, materials, design, and operational principles, as required for 510(k) clearances for traditional medical devices. There is no mention of any performance studies involving patient data or expert evaluations in the context of an AI/ML device.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.