(103 days)
The Vilex X-Fix is intended for external fixation with the following indications:
- Stabilization of Fractures & Osteotomy
- Rear & Mid-foot Foot Arthrodesis
- Adult and Pediatric Leg Lengthening
- Correction of Bone Deformity in Upper & Lower Extremities.
Not Found
The provided text is a 510(k) summary for the Vilex External Fixation System, X-Fix. This document is for a medical device (an external fixation system), not a diagnostic AI software. Therefore, the questions related to the acceptance criteria for AI/ML performance, study design for AI models, ground truth establishment, expert adjudication, and sample sizes for training/test sets are not applicable to this submission.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than on performance derived from a study involving AI or machine learning. The acceptance criteria for such a device would typically relate to mechanical performance (e.g., strength, durability, biocompatibility) and clinical effectiveness for its stated indications, usually supported by a comparison to existing devices and bench testing, not by AI performance metrics.
Therefore, I cannot provide the requested information as it pertains to AI/ML device performance. The document focuses on regulatory approval for a physical medical 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.