(26 days)
The EBI® XFIX® DFS® 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 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 the Hip Distracter to the System.
This submission is a Special 510(k) Device Modification for the EBI® XFIX® DFS® Fixation System (K022319), adding a Hip Distracter. The submission relies on substantial equivalence to the predicate device, the EBI® XFIX® DFS® System (K953406).
Acceptance Criteria and Device Performance:
The document does not explicitly define acceptance criteria as a new device or a new clinical claim is not being made. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material Equivalence | The modified EBI® XFIX® DFS® System is fabricated from the same materials as the components of the currently marketed EBI® XFIX® DFS® Fixation System (Aluminum, Stainless Steel, Cobalt Chrome, Carbon Fiber, and Titanium Alloy). |
| Intended Use Equivalence | The modified EBI® XFIX® DFS® System and the currently marketed EBI® XFIX® DFS® System are both indicated for 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. |
| Functional Equivalence of Bone Screw Clamps | The bone screw clamps of the modified EBI® XFIX® DFS® System, like the bone screw clamps currently marketed in the EBI® XFIX® DFS® System, are designed for attachment to the bone screws. |
| Sterilization Status Equivalence | The additional component of the EBI® XFIX® DFS® System, like the components of the currently marketed EBI® XFIX® DFS® System, is provided non-sterile. |
| Overall Substantial Equivalence (Intended Use, Materials, Function) | 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. This implies that the device performs equivalently to the predicate and thus meets the safety and effectiveness profile of the predicate device, which is already legally marketed. |
Study Information:
The provided document is a 510(k) summary for a device modification, not a clinical study report. Therefore, it does not describe a new clinical study with the traditional elements of acceptance criteria, sample size, ground truth, or expert review for performance evaluation. Instead, the "study" is a comparison to a legally marketed predicate device.
- Sample size used for the test set and the data provenance: Not applicable. This submission is based on a comparison of device characteristics to a predicate, not a test set of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in clinical trials or diagnostic accuracy studies is not relevant here as there is no new clinical data being presented for review. The "ground truth" is established by the prior clearance of the predicate device.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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. This is not an AI/software device and no MRMC study was conducted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this 510(k) is the regulatory acceptance and safety/effectiveness profile of the predicate device (EBI® XFIX® DFS® System K953406). The modified device is deemed substantially equivalent based on its inherent characteristics matching those of the predicate, and therefore, it is considered safe and effective for its intended use, similar to its predicate.
- The sample size for the training set: Not applicable. This is not a machine learning device.
- How the ground truth for the training set was established: Not applicable.
§ 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.