(30 days)
The EBI® XFIX® DFS® System is 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 DFS 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 DFS System is attached to the shanks of the bone screws. The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of a XS Gradual Swivel Clamp to the System.
This FDA submission for the EBI® XFIX® DFS® System is a 510(k) for a modified device, meaning it is seeking clearance based on substantial equivalence to a legally marketed predicate device rather than presenting a new product. Therefore, a study demonstrating device performance against specific acceptance criteria is not included in this document.
510(k) submissions for substantial equivalence generally focus on demonstrating that the new device shares fundamental scientific technology, intended use, materials, and functional characteristics with a previously cleared predicate device, and that any differences do not raise new questions of safety or effectiveness. They do not typically require new clinical studies with defined acceptance criteria and statistical analysis in the same way a PMA (Pre-Market Approval) or de novo submission would.
Here's an analysis based on the provided text, highlighting why most of your requested information is not applicable or cannot be extracted:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. This document does not establish specific performance acceptance criteria for the modified EBI® XFIX® DFS® System, nor does it report on a study designed to demonstrate performance against such criteria. The basis for clearance is substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. No test set or clinical study data is presented in this 510(k) summary. The submission relies on a comparison of technological characteristics to a predicate device, not on new performance data from a "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. As no test set or clinical study is described, there's no mention of experts establishing ground truth. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or clinical study, thus no adjudication method is relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not provided. This device is an external fixation system, not an AI-powered diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is a mechanical external fixation device, not an algorithm, so independent algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implicit Ground Truth for 510(k): The "ground truth" for a 510(k) substantial equivalence determination is the regulatory classification and established safety and effectiveness of the predicate device (EBI® XFIX® DFS® System, K953406). The submission argues that the modified device does not introduce new questions of safety or effectiveness compared to this already cleared device.
8. The sample size for the training set
- Not applicable / Not provided. This is a mechanical device, not an AI/machine learning system, so the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As above, the concept of a training set is not applicable to this submission.
Summary of Device Comparison (from Section 7):
The submission highlights the following points to demonstrate substantial equivalence:
- Materials: Fabricated from the same materials as the predicate device components (aluminum, stainless steel, titanium alloy).
- Intended Use: Both the modified and predicate devices are indicated for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other amenable bone conditions.
- Function: Bone screw clamps of the modified system are designed for attachment to bone screws, similar to the predicate.
- Sterility: The additional component (XS Gradual Swivel Clamp), like existing components, is provided non-sterile.
The core argument is: "There are no significant differences between the modified EBI XFIX DFS System and the currently marketed EBI XFIX DFS System. It is substantially equivalent to the predicate device with regard to intended use, materials, and function." The addition is specifically for an "XS Gradual Swivel Clamp."
This type of 510(k) relies on a direct comparison and argument of equivalence rather than new performance studies.
§ 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.