(135 days)
The Synthes Angular Stable Locking System (ASLS), when used with Synthes Cannulated Titanium Intramedullary Nails, is intended to aid in the alignment and stabilization of tibial, humeral, femoral, and ankle fractures.
The Synthes Angular Stable Locking System (ASLS) is designed as an alternative device for the interlocking of Synthes Cannulated Titanium Intramedullary Nails. The ASLS consists of a titanium screw with a 70:30 Poly (L/DL-Lactide) sleeve and is available in diameters ranging between 4.0 mm - 6.0 mm and overall lengths ranging between 23 mm - 125 mm.
The provided text is a 510(k) summary for the Synthes Angular Stable Locking System (ASLS). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. This document is a regulatory submission and approval letter, not a detailed study report.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The requested information is simply not present in this document.
§ 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.