(56 days)
The AOS Fibonacci Proximal Tibia Plating System is intended for the fixation of fractures, malunions, osteopenic bone, and tibial osteotomies of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
The AOS Proximal Tibia Plating System consists of precontoured, single use, open reduction internal fixation Lateral Proximal Tibia Plates and Posteromedial Proximal Tibia Plates, manufactured from titanium alloy, and AOS Fibonacci screws 3.5mm in diameter or larger. These plates and screws, and their dedicated accessories and sterilization trays, will be added to the AOS Fibonacci Lower Extremity Plating System. The 4.0mm Fixed Angle Locking Screws are single use titanium alloy orthopedic fixation screws, designed for use with all plates in the Fibonacci Lower Extremity Plating System, including the proximal tibia plates. The 3.5mm Diamond Workhorse Screws are single use titanium alloy orthopedic fixation screws with a faceted cut core diameter, designed for use with all plates in the Fibonacci Lower Extremity Plating System, including the proximal tibia plates.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Type) | Reported Device Performance (Summary) |
|---|---|
| Static Four-Point Bend Testing (per ASTM F382) | Results, alongside other tests, demonstrated substantial equivalence to predicate devices. |
| Fatigue Four-Point Bend Testing (per ASTM F382) | Results, alongside other tests, demonstrated substantial equivalence to predicate devices. |
| Torsion Strength Testing (per ASTM F543) | Results, alongside other tests, demonstrated substantial equivalence to predicate devices. |
| Insertion Torque Testing (per ASTM F543) | Results, alongside other tests, demonstrated substantial equivalence to predicate devices. |
| Pullout Strength Testing (per ASTM F543) | Results, alongside other tests, demonstrated substantial equivalence to predicate devices. |
| Internal Engineering Analysis (Not a specific test) | Contributed to the overall demonstration of substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test. It generally refers to "the AOS Proximal Tibia Plating System" being subjected to various tests. The data provenance is not specified (e.g., country of origin). The testing described is prospective as it was conducted to demonstrate substantial equivalence for a new device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a metallic bone fixation appliance, and the "ground truth" is established through mechanical and engineering performance testing, not through expert human assessment of images or clinical outcomes in the same way an AI diagnostic device would be.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the assessment is based on objective mechanical testing against established standards (ASTM F382, ASTM F543) rather than human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human readers' performance is being evaluated with and without AI assistance. This document describes a medical device (bone plating system) where performance is assessed through physical and mechanical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device. The document describes the mechanical performance of a physical medical implant.
7. The Type of Ground Truth Used
The "ground truth" in this context is defined by the performance requirements outlined in the referenced ASTM standards (ASTM F382 for static and fatigue bending, and ASTM F543 for torsion, insertion torque, and pullout strength). The performance of the predicate devices, which are legally marketed, also serves as a benchmark for "ground truth" in the substantial equivalence argument.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device and therefore does not have a "training set" in that sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.