(171 days)
Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; . reconstructive surgery; and craniofacial surgery
ENT: trauma of the nasal bones .
Neurosurgery: osteosynthesis of the cranial bones. .
The Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in:
- Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; . reconstructive surgery; and craniofacial surgery
- ENT: trauma of the nasal bones .
- Neurosurgery: osteosynthesis of the cranial bones. .
The plates are available in a variety of shapes and sizes and attach to bone via 2.0 mm, 2.4 mm, or 2.7 mm self-tapping screws.
Synthes will provide the device non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended.
This document is a 510(k) Summary for a medical device called the "Synthes Mandibular Modular Fixation System." It focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not present information related to acceptance criteria or studies involving device performance in the context of AI, human readers, ground truth, or statistical sample sizes in a clinical or imaging diagnostic setting.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, AI study details, or ground truth establishment based on the provided text. The document describes a traditional medical device (plate and screw system) and its mechanical testing for regulatory clearance, not a diagnostic AI or imaging device study.
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Attachment VI:
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Summary of Safety and Effectiveness Information [510(k) Summary]
SYNTHES (USA) 1690 Russell Road Paoli, PA 19301
(610) 647-9700 Contact: Angela Silvestri September 15, 1995
Device: Synthes Mandibular Modular Fixation System, as compared to the W. Lorenz Würzburg Titanium Miniplate System.
The Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in:
- Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; . reconstructive surgery; and craniofacial surgery
- ENT: trauma of the nasal bones .
- Neurosurgery: osteosynthesis of the cranial bones. .
The plates are available in a variety of shapes and sizes and attach to bone via 2.0 mm, 2.4 mm, or 2.7 mm self-tapping screws.
The W. Lorenz Würzburg Titanium Miniplate System, manufactured from titanium, and is intended for use in the following:
- Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; . reconstructive surgery; and craniofacial surgery
- ENT: trauma of the nasal bones .
- Neurosurgery: osteosynthesis of the cranial bones .
The plates are also available in a variety of shapes to accommodate various fracture types, and attach to bone via 2.0 mm or 2.3 mm self-tapping screws.
Synthes will provide the device non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended.
Based on mechanical test results, the Synthes Mandibular Fixation System is substantially equivalent to the W. Lorenz Würzburg Titanium Miniplate System.
§ 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.