(118 days)
The OIC Intramedullary Nail System is intended for surgical management of femoral and tibial fractures including open and closed fractures, pseudarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, nonunions and malunions. The hip nails may be used for basilar neck, subtrochanteric and intertrochanteric fractures. The femoral nails may be used for fractures of the femur below the hip joint including ipsilateral femur fractures, fractures proximal to a total knee arthroplasty and supracondylar fractures, including those with intra-articular extension.
The OIC Intramedullary Nail System consists of titanium nail for the tibia and femur, nail locking bolts, lag screws and instruments for implantation. The nails come in a variety of sizes and are pre-contoured to match the anatomy of the patient and accept 5.0mm locking bolts range in length from 20mm to 130mm. The lag screws are 10.5mm in diameter and range in length from 70mm to 120mm.
The intramedullary nails, bolts and screws are made of titanium alloy Ti-6Al-4V ELI in compliance with ASTM F136 or with Ti6Al4V in compliance with ASTM F1472.
The implants contained in the OIC Intramedullary Nail System are provided in both the non-sterile condition. Implants provided in the sterile condition will be sterilized with gamma radiation in accordance with methods and protocols outlined in ISO 11137-1:2006.
The provided text is a 510(k) premarket notification document for a medical device called the "OIC Intramedullary Nail System." This document is related to demonstrating substantial equivalence to legally marketed predicate devices for the purpose of market clearance by the FDA. It does not contain information about a study based on artificial intelligence/machine learning (AI/ML) with a test set, expert ground truth, or performance metrics typically associated with AI/ML device validation.
Therefore, I cannot extract the information required to populate a table of acceptance criteria and reported device performance from this document, nor can I provide details about sample sizes, ground truth establishment, or multi-reader multi-case studies as these concepts are not addressed in the context of this traditional medical device clearance.
The "acceptance criteria" and "study" described in the prompt are characteristic of the validation process for AI/ML-driven medical devices or diagnostic systems. The provided document details the substantial equivalence of an orthopaedic implant system (intramedullary nails, bolts, and screws) based on its intended use, materials, and function compared to existing predicate devices, and a geometric comparison and mechanical characteristic evaluation of the nails and nail-lag screw constructs.
In summary, this document does not contain the type of information needed to answer your detailed questions about AI/ML device validation.
§ 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.