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The Synthes Trochanteric Fixation Nail- Advanced (TFNA) System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
Specifically the system is indicated for:

• Stable and unstable pertrochanteric fractures
• Intertrochanteric fractures
• Basal neck fractures
• Combinations of pertrochanteric, intertrochanteric, and basal neck fractures
  The Long Nail is additionally intended for treatment of fractures in adults and adolescents (12- 21) in which the growth plates have fused for the following indications:
• Subtrochanteric fractures
• Pertrochanteric fractures associated with shaft fractures
• Pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions
• Long Subtrochanteric fractures
• Proximal or distal non-unions, malunions and revisions
  Both the short and long TFNA systems are additionally indicated for use with cleared polymethylmethacrylate (PMMA) bone cement that can be delivered through the fenestrated blade or screw via a cannula in skeletally mature adults with risk of cut-out or device instability due to poor bone quality.

The DePuy Synthes TFNA Augmentation System consists of components to the predicate DePuy Synthes TFNA System with added perforations to the femoral head elements. The perforations enable the delivery of cleared PMMA bone cement(s) to be delivered through the helical blade/femoral neck screw in patients with poor bone quality and/or increased risk of fixation failure at the implant/bone interface.
The materials of manufacture are the same as those used to manufacture the predicate TFNA hardware: Ti-15Mo (ASTM F-2066); Ti-6Al-7Nb (ASTM F1295); 40Co-20Cr-16Fe-15Ni-7Mo (ASTM F1058)

The provided document is a 510(k) premarket notification for the DePuy Synthes TFNA Augmentation System. It does not describe a study involving an AI/machine learning device or model; instead, it concerns a physical medical device (an intramedullary fixation rod). Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and studies proving the device meets those criteria, particularly in the context of AI/ML performance.

The document discusses substantial equivalence to a predicate device based on:

• Similar intended use, indications, design characteristics, functionality, materials, and performance.
• Dynamic fatigue testing comparing fenestrated and non-fenestrated head elements.
• Biomechanical evaluation of cut-out resistance.
• Evaluations to confirm the ability of the fenestrated hardware to deliver bone cement in a controlled and predictable manner (flow patterns, extraction validations).

Since the request focuses on acceptance criteria and a study for an AI device, and this document pertains to a physical orthopedic implant, I cannot extract the requested information.

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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.

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