(87 days)
The Skeletal Dynamics Distal Elbow Plating System is indicated for fixation of fractures, osteotomies and nonunions of the radius and ulna, particularly in osteopenic bone.
The predicate Skeletal Dynamics Distal Elbow Plating System (K171590) consists of medical grade titanium alloy radial head plates, proximal ulna plates, double hockey stick, Y and coronoid plates designed for fracture fixation, fusions, osteotomies and non-unions of the proximal radius and ulna. Included in the system are titanium bone screws and pegs, cobalt chrome cannulated polyaxial screws, k-wires, and specialized instrumentation.
The system is provided non-sterile and is sterilized in the user facility.
The modifications to the currently marketed Distal Elbow Plating System include the following.
- . Two new Proximal Ulna Plate extension options
- New 3.5mm FreeFix™ screw options .
- Addition of Protean Radial Head Plate configurations. .
- Addition of Modified Proximal Ulna Plate configurations. .
The provided text is a 510(k) premarket notification for a medical device called the "Distal Elbow Plating Sytem." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and performance testing for mechanical properties.
Crucially, this document does NOT describe an AI/ML-driven device or study involving acceptance criteria for device performance in terms of diagnostic accuracy, sensitivity, specificity, or human-in-the-loop studies.
Therefore, I cannot extract the information required by your prompt, such as:
- A table of acceptance criteria and reported device performance (in the context of AI/ML diagnostic performance)
- Sample size for test set and data provenance
- Number of experts used to establish ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used
- Sample size for training set
- How ground truth for training set was established
The "Performance Testing" section in the document refers to mechanical testing (e.g., ASTM standards for metallic bone plates and screws) to ensure the physical integrity and strength of the implant device, not its performance as a diagnostic or AI-assisted tool.
In summary, this document is entirely unrelated to the type of AI/ML device performance study details requested in your prompt.
§ 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.