(118 days)
Intended to stabilize shaft fractures between the proximal and distal third of the tibia. Indications include transverse, comminuted, spiral, oblique, and segmental fractures. The Tibial Nail may also be used for treatment of mal-unions as well as prophylactic nailings of impending pathological fractures.
The DGIMED Ortho DISTALOCK™ Tibial Intramedullary Nail System permits an intramedullary approach for fixation of fractures of the tibia: The DISTALOCK™ Tibial Naillis a closed section, cannulated, curved intramedullary fixation device containing four proximal (three static and one dynamic) and three distal holes to accept locking screws which thread transversely though the proximal and distal third of the tibia. The DISTALOCK™ Tibia Intramedullary Nail System includes the following components: DISTALOCK™ Tibial Intramedullary nails, locking screws and end caps made of titanium alloy. The DISTALOCK™ Tibial Ancillary Instrumentation includes the DISTALOCK™ Tibial Drill and other disposable and reusable instruments needed for accessing the tibial medullary canal; preparing the bone for placement and installation of the nail and locking screws, and removal of the nail and locking screws if required.
The provided text describes a medical device, the DISTALOCK™ Tibial Intramedullary Nail System, and its clearance process. However, it does not contain any information regarding clinical studies, acceptance criteria, or performance metrics in the context of AI/ML device evaluation.
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing (bench testing, cadaver testing, material biocompatibility, and human factors analysis). It explicitly states: "No new risks or efficacy concerns other than those identified with the predicate device were raised. Results of non-clinical testing demonstrated that the DISTALOCK™ Tibial Intramedullary Nail System is safe and effective for its intended use."
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text, as this information is not present. The document focuses on demonstrating substantial equivalence through engineering and material testing, not on clinical performance metrics or an AI/ML component.
§ 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.