(76 days)
The Synthes External Midface Distractor is intended for use in craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy, the midface utilizing a Lefort II or III osteotomy, and/or the cranium utilizing a monoblloc osteotomy in adult and pediatric populations where gradual bone distraction is required.
The Synthes External Midface Distractor is an external distraction osteogenesis device that attaches to the cranium and midface and is used to gradually lengthen the midface at the LeFort I, II, and III levels (including monobloc). The device consists of an external headframe, a central adjustment mechanism, a veridical central rod, horizontal crosspieces containing distraction screws, and separate footplates assemblies that attach to the zygoma and maxilla.
The provided text is a 510(k) summary for the Synthes External Midface Distractor. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a clinical study with acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, as it's not a clinical trial report designed to establish de novo safety and effectiveness.
Here's why the requested information cannot be extracted from this document:
- Acceptance Criteria and Reported Performance: The document does not define specific performance metrics or acceptance criteria for the device's function (e.g., specific distraction rate, stability, force application limits) that would be evaluated in a study. It focuses on the device's description and intended use.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Study, Training Set Information: A 510(k) summary relies on demonstrating similarity to existing devices and does not typically include information about clinical studies with human participants, ground truth establishment, expert adjudication, or AI algorithm performance (as this is a medical device, not an AI software).
The key takeaway from this document is that the FDA determined the device is substantially equivalent to predicate devices, meaning it has similar indications for use and technological characteristics, and raises no new questions of safety or effectiveness. This is a different regulatory pathway than demonstrating de novo safety and effectiveness through a clinical trial with pre-defined acceptance criteria.
§ 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.