(329 days)
RemeOs™ Screw LAG Solid is intended for the use in traumatic and orthopedic surgery for the fixation of bone fractures (osteosynthesis) and for the fixation after osteotomies, e.g., for the correction of deformities or malalignments. The absorbable implants serve as temporary fixation and stabilization by osteosynthesis of bone fractures and osteotomies until bony fusion has occurred.
The RemeOs™ Screw LAG Solid is intended to be used for skeletally mature adults.
The RemeOs™ Screw LAG Solid is indicated for the fixation of the medial malleolus.
The RemeOs™ Screw LAG Solid is an absorbable metallic bone fixation fastener. The product is manufactured from an absorbable magnesium-based alloy containing magnesium, zinc (0.55% (w/w)) and calcium (0.45% (w/w)). The material corrodes under physiological conditions into magnesium, calcium and zinc oxides and hydroxides, while producing hydrogen gas as byproduct. The implant serves as temporary fixation and stabilization by osteosynthesis of bones and fragments until bonv fusion has occurred.
The RemeOs™ Screw LAG Solid is provided in one design (Figure 1). The RemeOs™ Screw LAG Solid is a partially threaded solid headed screw with a diameter of 3.5 mm and is offered from lengths 24 to 40 mm in 2 mm increments.
This document describes the De Novo Classification Request for RemeOs™ Screw LAG Solid, an absorbable metallic bone fixation fastener. The provided text primarily focuses on the device's design, biocompatibility, sterilization, MR compatibility, and substantial mechanical and early clinical performance. However, there is no information about an AI/ML-driven device or an AI model’s performance study. The request is for a physical medical device. Therefore, I cannot generate the requested table and study description for an AI device.
The provided text details the acceptance criteria and the study proving the physical medical device (RemeOs™ Screw LAG Solid) meets those criteria. However, your request specifically asks for information related to an AI/ML device's acceptance criteria and performance study, including aspects like sample size for test/training sets, experts, adjudication methods, MRMC studies, and standalone AI performance.
Since the provided text does not describe an AI/ML device, I cannot fulfill your request for an AI model's performance study description based on this input. The information provided is entirely about the physical characteristics and performance of a resorbable metallic screw.
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