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The Affixus® Tibial Nailing System is indicated for temporary stabilization of tibial fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, closed fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections.

The Affixus Tibial Nalling System is a long bone nailing system that offer implants designed to treat a range of tibial fractures from simple to complex, with versatile locking options. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Screws and End Caps are included in the system. All implants are made of Ti-6Al-4V. The Affixus platform of instrumentation is designed to provide options and flexibility for many intraoperative approaches while maintaining ease of use and commonality. This submission introduces 4mm Cortical Bone Screws are also made of Ti-6AL-4V and feature a double-lead thread design with a self-tapping tip. Screw options include Ø4mm: 20mm - 60mm, increments of 2 mm 60mm - 90mm, increments of 5mm Note: 4mm Screws are inserted through distal locking holes of 8mm Tibia nails only.

It appears that the provided document is an FDA 510(k) clearance letter for a medical device (Affixus Tibial Nailing System - 4mm screws). This type of document is for device clearance based on substantial equivalence to a predicate device, not for the clearance of an Artificial Intelligence/Machine Learning (AI/ML) device.

Therefore, the document does not contain any information regarding:

• Acceptance criteria for an AI/ML model
• Study design for testing an AI/ML model's performance
• Sample sizes for test or training sets for an AI/ML model
• Expert involvement in ground truth establishment or adjudication for an AI/ML model
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance
• Ground truth types specific to AI/ML
• Training set details for an AI/ML model

The clearance is based on the device's material, design, packaging, and sterilization being substantially equivalent to existing predicate devices, and supported by non-clinical tests demonstrating mechanical properties (e.g., fatigue strength, bending strength, torque, pullout strength) and MR compatibility.

Conclusion:

Based on the provided text, it is not possible to describe the acceptance criteria and the study that proves an AI/ML device meets those criteria, as this document pertains to a traditional medical device (intramedullary fixation rod) and not an AI/ML product.

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Indicated for alignment, stabilization of fractures caused by trauma or disease, and the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity and for arthrodesis. This includes transverse fractures, oblique fractures, spiral fractures, segmental fractures, open fractures, open fractures, pathologic fractures, metaphyseal fractures with bone loss, prophylactic fixation of impending fractures, pseudoarthrosis of the tibial shaft, bone transport, nonunions, and corrective osteotomies.

The new Affixus Tibial Nailing System is part of a long bone nailing system that offers an implant design to treat a range of tibial fractures from simple to complex, with versatile locking options. These intramedullary nails offer specific anatomical features designed to aid in insertion, while also offering options to address both proximal and distal fractures. The proximal end of the nail features four screw holes while the distal end contains five. Both the proximal and distal ends offer oblique screw positions to provide maximum fracture stability and/or facilitate capture of distal fragments, as needed. The nails are intended to be used with 4.0 and 5.0mm non-locking screws and the system offers optional end caps that can be inserted into the top of the nail following implantation. The implants shall be offered in a sterile configuration. The system is to be used with a series of instrumentation to aid during the preparation and implantation of the nail, screws and end caps.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification for the "Affixus Tibial Nailing System," a medical device used for bone fixation.

The document focuses on demonstrating substantial equivalence of the Affixus Tibial Nailing System to previously cleared predicate devices. It describes the device, its intended use, indications for use, materials, design features, and sterilization, highlighting their similarity to the predicate devices.

While it mentions non-clinical performance testing (static and fatigue construct strength testing), this testing was conducted to demonstrate that the new device "withstood greater static load as well as fatigue load compared to the predicate device." This is a comparison for substantial equivalence, not a demonstration against pre-defined acceptance criteria for device performance as would be detailed in a clinical or specific performance study.

The document explicitly states: "Clinical Tests - None provided as a basis for substantial equivalence."

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as these details are not present in the provided text.

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