(20 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 "adapters" to the existing System, which allow connection to various EBI® XFIX® System Fixators. 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, specifically the EBI® XFIX® Vision® Fixation System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than for proving the safety and effectiveness of a novel device through clinical performance studies.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Here's why the requested information is absent and what the document does provide:
- Acceptance Criteria and Reported Device Performance: Not applicable for a 510(k) modification where substantial equivalence is claimed. The submission focuses on comparing the modified device's characteristics to a predicate device.
- Sample sizes for test set and data provenance: No test sets or clinical performance data are presented.
- Number of experts used to establish ground truth & qualifications: No ground truth establishment occurred as no performance study was conducted.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not present. These studies are typically for evaluating the impact of AI on human reader performance, which is not the focus of this 510(k).
- Standalone (algorithm only) performance: Not applicable as this is a mechanical fixation system, not an algorithm.
- Type of ground truth used: Not applicable as no performance study was conducted.
- Sample size for the training set: Not applicable as there is no algorithm or machine learning model in this device.
- How the ground truth for the training set was established: Not applicable.
What the document does discuss:
The primary purpose of this 510(k) submission is to demonstrate substantial equivalence between a modified EBI® XFIX® Vision® Fixation System and its predicate devices (K993886, K011711). The modification involves the addition of "adapters" to the existing system.
The comparison focuses on:
- Materials: Stating that the additional components are fabricated from the same materials as the currently marketed system (Aluminum Alloy, Stainless Steel, Pyromet® 718, Carbon Fiber, and Titanium Alloy).
- Intended Use: Confirming that the modified device has the same indications for use as the predicate: "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."
- Function/Design: Highlighting that the bone screw clamps of the modified system are designed for attachment to the bone screws, similar to the currently marketed system.
- Sterility: Both are provided non-sterile.
The conclusion is that "There are no significant differences between the modified EBI® XFIX® Vision® Fixation System and the currently marketed EBI® XFIX® Vision® Fixation System. It is substantially equivalent to the predicate device with regard to intended use, materials, and function."
§ 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.