(58 days)
The Align Anterior Ankle Fusion Plate is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.
The Align Anterior Ankle Fusion Plate is a bone fixation device consisting of an anatomical, anterior tibia plate and various locking and non-locking screws and a set of instruments used for implant site preparation and delivery. The plate is available in three configurations, a slim plate and a 2-tab plate (available in two widths). A central hole in the plate allows for angled placement of a "home run" screw to obtain axial compression across the tibiotalarcalcaneal) (TTC) joints. The 2-tab plate is designed with an anterior "window" to allow autologous grafting of the TT and visualization of fusion under fluoroscopy.
The provided document is a 510(k) premarket notification for a medical device called the "Align Anterior Ankle Fusion Plate." This document primarily deals with establishing substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific performance criteria through a study with human data. Therefore, it does not contain the information required to answer the questions about acceptance criteria, a test set, ground truth establishment, or clinical study specifics like MRMC studies or human reader improvement.
Specifically:
- No acceptance criteria table or device performance: The document does not specify quantitative acceptance criteria for device performance based on human data or medical imaging, nor does it report such performance. The reported "performance" is in terms of mechanical strength demonstrated via bench testing.
- No sample size for test set or data provenance: No clinical test set data is described. The "testing" mentioned is bench testing.
- No experts for ground truth: Since no clinical data or imaging interpretation is discussed, there is no mention of experts or ground truth establishment.
- No adjudication method: Not applicable as there's no clinical test set requiring adjudication.
- No MRMC comparative effectiveness study: The document explicitly states "No clinical testing was performed."
- No standalone (algorithm only) performance: This device is a physical medical implant, not an algorithm.
- No ground truth type: Not applicable as no clinical data or clinical interpretation is being evaluated.
- No sample size for training set: Not applicable as no AI/ML model or training set is involved.
- No ground truth for training set established: Not applicable.
The document focuses on:
- Device Description: The Align Anterior Ankle Fusion Plate is a bone fixation device for ankle arthrodesis.
- Predicate Devices: It lists several predicate devices (e.g., Extremity Medical Compression Screw, Extremilock Ankle Plating System).
- Technological Comparison: States that the subject device and predicate devices are equivalent in terms of indications for use, design, and material mechanical properties.
- Non-clinical Testing: Mentions "Bench testing including pull-out, torque on the screws and engineering analysis was used to demonstrate that the mechanical strength of the subject device was substantially equivalent to the predicate device."
- Clinical Testing: Explicitly states, "No clinical testing was performed."
- Conclusion: The device is "substantially equivalent" to its predicate device based on indications for use, principles of operation, design, and mechanical test data.
In summary, this document is a regulatory filing for a medical implant, demonstrating equivalence based on design and mechanical bench testing, not a study evaluating clinical performance, especially not one involving AI/ML or human readers interpreting medical images. Therefore, the information requested in the prompt is not present in the provided text.
§ 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.