(84 days)
The Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and craniofacial skeleton, craniofacial surgery, reconstructive procedures and selective orthognathic surgery of the maxilla and chin.
Synthes Orbital Plates, components of the Synthes Craniofacial Plate and Screw System, consist of anatomically shaped orbital plates that come in various sizes and configurations to fit the patient anatomy. These devices are designed for use with Synthes craniofacial bone screws commercially available in the U.S. System components are manufactured in titanium and are intended for single use only.
This is a 510(k) premarket notification for a medical device called the "Synthes Craniofacial Plate and Screw System." This type of document is typically submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, and thus does not require a full premarket approval (PMA) process.
The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics like sensitivity, specificity, or reader improvement. This is because the device, a bone plate and screw system, is assessed for substantial equivalence primarily based on its materials, design, indications for use, and mechanical testing (which is alluded to but not detailed here) rather than diagnostic performance as one would find for an AI/ML powered device.
Therefore, I cannot provide the requested table or answer the specific questions related to acceptance criteria, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth as these concepts are not applicable to the information provided in this 510(k) summary.
The document indicates "Documentation is provided that demonstrates the Synthes Orbital Plates are substantially equivalent to other legally marketed devices," but the details of that documentation (e.g., mechanical testing protocols, results, or comparison to predicate device characteristics) are not included in the provided text.
§ 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.