(81 days)
This device is used in surgery for the application of wires to the jaws of adults and children. The device can be used to directly wire bony segments together, or for the application of arch bars to the teeth for stabilization of bony fragments or wiring the teeth together (maxillomandibular fixation).
22, 24 and 26 gauge annealed 316LVM stainless steel wire in 5 ft. coils packaged in a thermoplastic cartridge that mounts on forceps
This request cannot be fulfilled. The provided text is a 510(k) summary for a medical device (Aragon Wiring System Wire Cartridge) which outlines its substantial equivalence to existing predicate devices. However, this type of document, particularly for devices like wires for mandibular fixation, typically does not contain acceptance criteria for device performance or the results of a study designed to prove the device meets such criteria.
Medical devices cleared through the 510(k) pathway demonstrate substantial equivalence, meaning they are as safe and effective as a legally marketed predicate device. This often relies on comparing technical characteristics, materials, and intended use to existing devices, rather than conducting new performance studies with specific acceptance criteria and detailed statistical analysis on human subjects that would be typical for a drug or a novel, high-risk medical device.
Therefore, I cannot extract the requested information because it is not present in the provided text. The document explicitly states: "The technical differences between this product and the predicate devices do not adversely affect safety or efficacy," which is the core conclusion for a 510(k) clearance, not a report of meeting specific performance metrics through a study.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.