(79 days)
Synthes Neuro 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 Neuro Plate and Screw System consists of plates, burr hole covers, and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium or titanium alloy and are intended for single use only.
The provided document is a 510(k) summary for the Synthes (USA) Neuro Plate and Screw System and a letter from the FDA determining substantial equivalence. This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it's a medical device clearance submission, not a performance study report.
The content within the provided text focuses on:
- Device Identification: Product name, sponsor, classification, predicate devices.
- Device Description: Components, materials, intended use.
- Regulatory Information: Substantial equivalence determination by FDA.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study details, as these are not present 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.