(73 days)
The AOS Modular Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following.
- Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections
- Supracondylar fractures, including those with severe comminution and intra articular extension
- Ipsilateral femur fractures
- Bone lengthening
- Fractures proximal to a total knee arthroplasty or prothesis
- Fractures distal to a hip joint
- Nonunions and malunions
- Fractures resulting from osteoporosis
The AOS Femoral Modular Nail is also indicated for use in fusion of the knee and in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia.
The Advanced Orthopaedic Solutions (AOS) Modular Femoral Nail is a titanium alloy modular nail consisting of a elongated nail body with a chamber at the proximal end that is designed to receive an insert with various screw hole configurations (antegrade, reconstruction, retrograde, dynamization, TTC fusion, etc.). A locking ring engages into the chamber to secure and retain the insert into the chamber. Additionally, there is an endcap that is threaded into the proximal end of the nail to preload the locking ring to prevent loosening. The endcap also prevents the ingrowth of tissue into the proximal threads. The screw holes in the insert are designed to receive 6.5mm screws (antegrade, retrograde and TTC fusion) and 6.5mm and 4.5mm screws (reconstruction). The nail is cannulated through it entire length with the distal end of the nail containing three screw holes designed to receive 4.5mm screws. Nails of 30cm and longer have a radius to accommodate the anatomy of the femur.
The overall diameter of the proximal chamber is 13mm regardless of the diameter of the nail and the working length diameters ranges from 9mm to 13mm. The nail is produced in lengths of 15cm to 50cm.
The inserts are identical overall dimensions but contain various screw hole configurations. The antegrade insert has one screw hole angled at 45°, the reconstruction insert has two holes that are also angled 45° into the femoral head, The retrograde/supracondylar insert has on cross locking hole and one slot and the TTC fusion insert had three cross locking holes.
The provided text is a 510(k) summary for a medical device called the "AOS Modular Femoral Nail." This document focuses on demonstrating substantial equivalence to existing devices rather than presenting a study with acceptance criteria and performance data for a new AI/software-based medical device.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided text. The document describes a traditional medical device (an intramedullary fixation rod) and its regulatory clearance process based on its similarity to previously cleared devices.
Here's why the requested information cannot be extracted from the document:
- Acceptance Criteria and Reported Device Performance: These are typically found in performance studies for new devices, especially software or AI. This document doesn't detail performance metrics or acceptance criteria for the "AOS Modular Femoral Nail" beyond its intended use and mechanical description. The regulatory approval is based on substantial equivalence, not a new performance study against defined criteria.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Study, Ground Truth (for a specific study), Training Set Sample Size, and Training Set Ground Truth: All these points relate to a performance study, which is absent from this 510(k) summary. The summary focuses on comparing the new device's design and intended use to predicate devices, supported by a general description of the device's features and materials.
In summary, the provided document does not contain the type of study information required to answer your specific questions, as it is a 510(k) summary for a physical medical device demonstrating substantial equivalence, not a performance study for a software/AI-based medical 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.