(90 days)
The Lorenz Reconstruction System with Modular Screw is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
The Lorenz Reconstruction System with Modular Screw has been designed to include two plate thickness profiles; the low profile plates, 0.079" thick, and the high profile plates, 0.102" thick. Both plate profiles will have a threaded hole design for use with the modular screw. The threaded holes, spaced 0.295" apart, have an oval countersink to allow a standard screw greater angulation and compression, as necessary.
The modular screw is a two piece design; a detachable head and a threaded body for insertion into the bone. The detachable head has an inner and outer thread profile. The outer thread profile is for locking the screw head to the plate. The inner thread profile is for detaching and reattaching the head from the threaded body of the screw, as necessary. The detachable head can be taken off the threaded body of the screw after insertion into the bone. This allows the surgeon to correctly position the plate before a resection procedure. The screw head and reconstruction plate can then be removed for the resection procedure, leaving the body of the screw as points of reference for correct repositioning of the mandible after the procedure.
1.5 mm "add on" plates have been designed for use when the defect site includes bone fragments or pieces that require additional stabilization. The "add on" plates attach to the reconstruction plate using only the modular head or recon plug. The fixation of the "add on" plate to the bone site requires a standard 1.5 mm screw.
This document describes a 510(k) premarket notification for the "Lorenz Reconstruction System with Modular Screw," a medical device intended for mandibular fracture stabilization and reconstructive surgery. However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.
The document is primarily a regulatory filing (510(k) summary and FDA clearance letter) that assesses substantial equivalence to existing devices rather than presenting the results of a detailed performance study against specific acceptance criteria.
Therefore, I cannot fulfill your request with the provided input. There is no data in the text to populate the requested table or answer the specific questions about device performance and study methodology.
§ 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.