(112 days)
The SonicWeld Rx Endobrow Fixation will be used to support non-load bearing tissues of the craniofacial skeleton, including but not limited to endobrow fixation.
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The provided text is a 510(k) summary for the SonicWeld Rx Endobrow Fixation device, which is a bone plate. 510(k) summaries primarily focus on demonstrating substantial equivalence to predicate devices and detailing the intended use and classification of the device.
Therefore, the document does not contain information related to acceptance criteria, specific device performance studies, or clinical trial details such as sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment.
A 510(k) submission generally relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing device features, materials, and mechanical properties, but typically does not involve the kind of detailed clinical study data and performance metrics that would be found in a PMA (Pre-Market Approval) application or a clinical trial report.
Based on the provided text, I cannot complete the requested tables and information.
§ 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.