(142 days)
The Skeletal Dynamics Distal Elbow Plating System is intended for fixation of fractures, fusions, osteotomies and non-unions of the radius and ulna, particularly in osteopenic bone.
The Skeletal Dynamics Distal Elbow System consists of various bone plates designed for fracture fixation, fusions, osteotomies and non-unions of the radius and ulna. Included in the system are titanium bone screws and pegs, cobalt chrome cannulated polyaxial screws, k-wires, and specialized instrumentation.
The Radial Head and the Proximal Ulna plates are made of medical grade titanium alloy. They are offered in left and right applications. The Proximal Ulna plate is provided in various lengths. The system is provided non-sterile and is sterilized in the user facility.
The Skeletal Dynamics Fragment Plate System is comprised of:
- · Titanium alloy plates and screws
- Cobalt chrome polyaxial screws
- · Stainless steel K-wires (for provisional fixation not for implantation)
- · System specific instrumentation.
This document is a 510(k) premarket notification for the "Skeletal Dynamics Distal Elbow Plating System." It describes the device, its intended use, and claims substantial equivalence to a predicate device based on performance testing. However, it does not contain the level of detail requested for acceptance criteria and a study proving those criteria are met for an AI-powered diagnostic device.
Here's why and what information is missing:
- This document describes a medical device (bone plating system), not an AI diagnostic device. The questions regarding ground truth, expert adjudication, MRMC studies, standalone performance, training sets, and data provenance are highly specific to AI/ML diagnostic tools. These concepts are not applicable to the mechanical bone plating system described here.
- The "Performance Testing" section states mechanical testing was performed, including static and dynamic testing on plates, and pullout strength and torque testing on screws. This is typical for orthopedic implants to demonstrate structural integrity and mechanical equivalence.
- The "Acceptance Criteria" for this type of device would generally involve meeting certain mechanical performance thresholds (e.g., strength, fatigue life, screw retention) set by recognized standards (like ASTM or ISO) relevant to orthopedic implants. These specific criteria and the detailed results showing compliance are summarized but not explicitly listed in this FDA letter, which instead focuses on the determination of substantial equivalence.
Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text because it pertains to a different type of medical device (a mechanical implant) than what your questions are designed for (an AI diagnostic tool).
If this document were about an AI diagnostic device, the necessary information would typically include sections detailing clinical study design, endpoints, statistical analysis, and comparisons to human performance or ground truth.
§ 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.