(300 days)
The IXOS Radius Plate System is intended for surgical procedures in which internal fixation by implants is required for aligning, reconstruction and stabilizing bone tissue.
It is used in particular for fixing intra- and extra articular acute fractures of the distal radius, in particularly
- · Type A2 Colles fractures
- · Type A3 fractures
- · Type B1 fractures
- · Type B2 Barton fractures
- · Type B3 Smith or reversed Barton fractures
- · Type C1 fractures
- · Type C2 fractures
- · Type C3 fractures
and in osteotomies of the distal radius.
The IXOS Radius Plate System is used for aligning, reconstructing and stabilizing bone tissue. It is used in the field of hand, accident and reconstructive surgery and orthopedics especially for the fixation of acute distal intra- and extra-articular fractures of the radius.
I am sorry, but the provided text is a summary of an FDA 510(k) clearance for a physical medical device (IXOS Radius Plate System), not an AI/ML-driven software as a medical device.
Therefore, the input does not contain information about:
- Acceptance criteria and reported device performance related to an AI/ML algorithm.
- Sample sizes, data provenance, ground truth establishment, or expert involvement for an AI/ML model.
- Any AI-related studies such as MRMC comparative effectiveness or standalone algorithm performance.
The document discusses the substantial equivalence of a bone fixation plate system to predicate devices based on material, design, and mechanical testing (static and dynamic 4-point bending tests), and biocompatibility.
As such, I cannot fulfill your request for information about the acceptance criteria and studies for an AI/ML device based on the given 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.