(25 days)
The Synthes Cranial Plates are intended for use in selective trauma of the midface and Craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
The Synthes burr hole covers come in various sizes to accommodate various fracture and osteotomy sites, have a low plate/screw head profile and use existing (previously cleared) 1.3 mm (1.7 mm emergency) or 1.5 mm (2.0 mm emergency) self-tapping bone screws.
The provided text is related to the 510(k) summary for Synthes Cranial Plates as submitted to the FDA in 2004. This document primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance studies and acceptance criteria for a new medical device technology, especially one involving AI or diagnostic capabilities.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or ground truth establishment.
The document states:
- "Comparative information presented supports substantial equivalence."
- The device is a "Bone Plate" (21 CFR 872.4760).
- The "Predicate Devices" are "Synthes Cranial Plates," indicating a comparison to their own existing devices.
This suggests that the approval was based on demonstrating that the new Synthes Cranial Plates are similar enough to previously approved Synthes Cranial Plates, rather than extensive new performance studies against specific acceptance criteria like those expected for a diagnostic or AI-driven device. Device effectiveness for such products is often based on material properties, design specifications, and manufacturing processes, which are not detailed in this summary.
§ 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.