(85 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 nay 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 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 lad 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.
The additional instruments being added to the OIC Intramedullary Nail System are provided in the non-sterile condition. They are made of surgical grade stainless steel or 6061-T6 Aluminum with a medical grade silicone or Radel handle.
This document, K181184, is a 510(k) premarket notification for the OIC Intramedullary Nail System, which is a Class II medical device (Product Code HSB) used for surgical management of femoral and tibial fractures.
Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI/ML algorithm.
The document discusses the addition of fifteen instruments to an existing OIC Intramedullary Nail System (primary predicate device K150655). The substantial equivalence claim is based on:
- Intended use: The new instruments support the existing intended use of the OIC Intramedullary Nail System.
- Materials: The instruments are made of surgical grade stainless steel or 6061-T6 Aluminum with a medical grade silicone or Radel handle, which are standard materials. The nails, bolts, and screws are made of titanium alloy Ti-6Al-4V ELI.
- Function: The added instruments aid in installing or extracting parts of the system, including tools for suprapatellar insertion of tibial nails.
- Mechanical characteristics: "The instrument constructs were found to have acceptable mechanical characteristics for the intended uses." This implies some form of testing, likely mechanical bench testing, but the details of the acceptance criteria and study are not provided in this document.
The "study" mentioned for establishing substantial equivalence refers to a geometric comparison to predicate devices and evaluation of mechanical characteristics, not a clinical study involving AI/ML performance metrics.
Therefore, I cannot populate the requested information regarding acceptance criteria and an AI/ML study because this document does not contain that type of information. It's a regulatory submission for a traditional orthopedic implant system, not a software as a medical device (SaMD) or an AI-enabled 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.