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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.

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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.

Ask a specific question about this device