(211 days)
The Synthes Midfacial System is a plate and screw system, manufactured from commercially pure (CP) titanium, and is intended for use in selective trauma of the midface and craniofacial skeleton: craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
The Synthes Midfacial System is a plate and screw system, manufactured from commercially pure (CP) titanium, and is intended for use in selective trauma of the midface and craniofacial skeleton: craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The plates are available in a variety of configurations to accommodate various fracture sites, and attach to bone via 1.3 mm or 1.7 mm self-tapping screws, with a low plate/screw profile.
This document is a 510(k) summary for a medical device (Synthes Midfacial System) and does not describe a study involving an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device cannot be extracted from the provided text.
The document primarily focuses on:
- Device Description: The Synthes Midfacial System, a plate and screw system for midfacial and craniofacial surgery.
- Predicate Device Comparison: It compares the Synthes system to the Howmedica Luhr Pan Fixation System.
- Basis for Equivalence: It states that equivalence is "Based on mechanical test results," implying physical/mechanical testing, not a clinical study involving AI.
Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance, human reader studies, or ground truth establishment.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small circle with an R inside is to the right of the word.
8 K953806
Attachment VI: Summary of Safety and Effectiveness Information [510(k) Summary]
SYNTHES (USA) 1690 Russell Road Paoli, PA 19301
(610) 647-9700 Contact: Angela Silvestri August 9, 1995
Device: Synthes Midfacial System, as compared to the Howmedica Luhr Pan Fixation System.
The Synthes Midfacial System is a plate and screw system, manufactured from commercially pure (CP) titanium, and is intended for use in selective trauma of the midface and craniofacial skeleton: craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The plates are available in a variety of configurations to accommodate various fracture sites, and attach to bone via 1.3 mm or 1.7 mm self-tapping screws, with a low plate/screw profile.
The Howmedica Luhr Pan Fixation System, manufactured from Vitallium® alloy, is also intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The plates are also available in a variety of configurations to accommodate various fracture sites. and attach to bone via 1.3 mm or 1.5mm self-tapping screws, with a low plate/screw profile.
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 Midfacial System is equivalent to the Howmedica Luhr Pan Fixation 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.