(352 days)
Double Engine Intramedullary Nail System is intended to be implanted into the medullary canal of tibia for alignment, stabilization, fixation of fractures caused by trauma or disease.
Double Engine Intramedullary Nail System is composed of intramedullary nails, interlocking screws, and end caps. Intramedullary nails are provided in variety of lengths and anatomical deigns to accommodate the medullary canal of long bones (tibia). Interlocking screws are used for axial compression and preventing rotation. End caps on intramedullary nails are intended to facilitate removal and to allow length adjustment of the nail.
The provided text does not contain information about acceptance criteria for a device's performance, a study proving device performance against such criteria, expert evaluations, or AI/software-related details.
The document is a 510(k) summary for the Double Engine Intramedullary Nail System, which is a physical orthopedic implant. It focuses on demonstrating substantial equivalence to a predicate device through bench tests of material properties and mechanical strength, rather than clinical performance or AI algorithm assessment.
Therefore, I cannot provide the requested information. The text describes a regulatory submission for a medical device based on physical and mechanical properties, not an AI or software device with specific performance metrics against clinical outcomes or expert ground truth.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.