(250 days)
The D.N.E. Ring Fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonumions of long bones, limb lengthening by epiphyseal or metaphyseal distraction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The D.N.E. Ring Fixator is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
The D.N.E. External Fixation System assembly consists of three basic types of elements: 1) bone anchorage elements, 2) bridge elements, and 3) connection elements. The design allows freedom of pin placement, ease of assembly and stable fixation of bone fragments with the possibility of axial loading of the extremity and immediate range of motion of all adjacent joints.
An Angular Correction Clamp and associated Struts have been added to the system in order to facilitate a surgeons ability to step down in ring sizes.
The provided text is an FDA 510(k) clearance document for a medical device called the "D.N.E. External Fixation System." This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study or a detailed performance evaluation with human experts and ground truth.
Therefore, the requested information regarding acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document.
The document states:
- Device Name: D.N.E. External Fixation System
- Intended Use: Open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening, correction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. It's for use on all long bones.
- Substantial Equivalence: The primary method for proving substantial equivalence was through mechanical testing (Static and Dynamic Axial Compression testing per ASTM F1541), comparing the subject device (with added Angular Correction Clamp and Struts) to the predicate device (K113106). The document states the testing showed the subject device to be substantially equivalent in terms of "intended use, mechanical safety and performances."
This type of 510(k) submission generally does not involve a clinical study with human readers and ground truth as might be seen for an AI/algorithm-based diagnostic device. The "performance" being evaluated here is mechanical, not diagnostic accuracy.
§ 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.