(27 days)
The EBI® XFIX® Vision® Fixation System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
The System consists of external fixation components and implantable bone screws. The EBI® XFIX® Vision® Fixation System is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue, and into the bone. The fixator frame of the EBI® XFIX® Vision® Fixation System is attached to the shanks of the bone screws. This submission is for the addition of "single locking" clamps to the existing System. The intended use and fundamental scientific technology have not changed from the previously cleared submission.
The provided text is a 510(k) Summary for a medical device modification (EBI® XFIX® Vision® Fixation System) and the FDA's clearance letter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for a new AI/software device.
Therefore, the document does not contain the information required to populate the fields related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.
The document describes a modification to an existing external fixation system, specifically the addition of "single locking" clamps. The manufacturer asserts that the modified device is substantially equivalent to the predicate device in terms of intended use, materials, and function. This type of submission relies on demonstrating that the changes do not raise new questions of safety or effectiveness and that the modified device performs similarly to the already cleared predicate.
No study proving the device meets acceptance criteria, as one would expect for an AI/software device, is described in this document. The basis for clearance is substantial equivalence to a predicate, not performance against specific metrics in a new study.
§ 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.