(67 days)
The Synthes Translating Maxillary 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 in adult and pediatric populations.
The Synthes (USA) Translating Maxillary Distractor is an intra-oral distraction device. It features a distractor body with two adjustable footplate components, each with contourable legs having screw holes that are fixed to the bone via 2.0 mm or 2.4 mm cortex screws.
This document is a 510(k) premarket notification for a medical device called the "Synthes (USA) Translating Maxillary Distractor." It is a regulatory submission to the FDA seeking clearance to market the device based on its substantial equivalence to a legally marketed predicate device.
Crucially, this document does not contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as it relates to AI/algorithm-driven device performance.
The 510(k) process for devices like the Translating Maxillary Distractor, particularly from 2002, primarily focuses on demonstrating substantial equivalence to existing devices through:
- Device description and intended use matching: Showing that the new device has similar design, materials, and purpose as a predicate.
- Material compatibility and mechanical testing: Ensuring the materials are safe and the device can withstand expected forces. This would typically involve engineering tests, not clinical performance metrics in the way AI models are evaluated.
Therefore, I cannot fulfill your request for the specified information because the provided text pertains to a traditional medical device submission (a mechanical surgical distractor) and not an AI/algorithm-driven diagnostic or treatment device.
If you have a document describing an AI-powered device, I would be happy to analyze it for the criteria you've outlined.
§ 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.