(92 days)
The SIGN IM Nail is indicated for internal fixation of diaphyseal tibial fractures and distal femur fractures including Transverse fractures, oblique and spiral fractures, comminuted fractures, fractures with bone loss, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions.
The SIGN IM Nail may be removed upon fracture healing.
The SIGN IM Nail system includes Intramedullary nails. Interlocking Screws and Instruments. All components are manufactured from stainless steel. The SIGN IM Nail is available with diameters of 8mm. 9mm. 10mm, 11mm, and 12mm in the following lengths: 150mm, 190mm, 270mm, 270mm, 280mm, 320mm, 320mm, 340mm, 360mm, 380mm, 400. Each nail is made from a solid type 316. ASTM F138, stainless steel bar with distal and proximal bends. Each nail has holes and/or slots at both the distal and proximal ends to accept solid 4.5mm diameter cortical bone screws.
This document describes a medical device, the SIGN IM Nail, which is an intramedullary nail for internal fixation of certain fractures. It is a traditional medical device, not a software algorithm or AI-powered solution. Therefore, the requested information about acceptance criteria, study findings, sample sizes for test and training sets, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable in the context of AI/algorithm performance.
The document states that the safety and effectiveness of the SIGN IM Nail is based on a long history of use of this type of device in the market place and its substantial equivalence to predicate devices (Smith & Nephew "TriGen®" Knee Nail, ACE Medical "AIM" Titanium Tibial Nail, Synthes "Universal Nail").
The FDA's decision to clear the device (K013132) is based on a substantial equivalence determination, meaning it is similar in intended use, technology, and performance to legally marketed devices. This process typically relies on device comparisons, material testing, and sometimes bench or animal testing, rather than the kind of clinical performance studies with specific acceptance criteria that would apply to AI/software.
Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of an AI study, nor can I provide information on sample sizes, ground truth, or expert involvement as these are not relevant to the substantial equivalence pathway for this type of conventional device.
§ 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.