(73 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 carbon fiber material for the Central Body Component, Ankle Clamp, and T-Clamp.
This document is a 510(k) summary for the modified EBI® XFIX® DFS® System, an external fixation device. It outlines the device's description, intended use, materials, and a comparison to a predicate device to establish substantial equivalence. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical or performance study for a diagnostic or AI-driven device would.
This 510(k) is for a modification to an existing, already cleared device (K953406). The modification involves adding carbon fiber material for certain components. The FDA’s review process for such modifications often focuses on showing that the new material does not significantly alter the device's safety or effectiveness compared to the predicate device, rather than requiring a new, comprehensive performance study with acceptance criteria and a detailed study design.
Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable or provided in this type of submission.
Here's a breakdown of the available information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
Not explicitly detailed in the way software or diagnostic device acceptance criteria would be presented. For this type of mechanical device modification, "acceptance" is primarily based on demonstrating substantial equivalence to a predicate device, meaning there are no significant differences in intended use, materials, and function that would raise new questions of safety or effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain intended use as predicate device | Intended use remains the same: "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." |
| Materials are substantially equivalent or safe for intended use | Components may be manufactured from materials such as aluminum, stainless steel, titanium alloy, and carbon fiber. (The modification adds carbon fiber, but this is presented as an equivalent material choice.) |
| Function is substantially equivalent to predicate device | "The bone screw clamps of the modified EBI XFIX DFS System, like the bone screw clamps currently marketed... are designed for attachment to the bone screws." There are "no significant differences... with regard to intended use, materials, and function." |
| Provided non-sterile, like predicate | "The additional component... is provided non-sterile." |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not applicable. There is no "test set" in the context of a clinical performance study as described for AI or diagnostic devices. The evaluation is based on material properties, design comparison, and functional assessment relative to the predicate.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No. This is not an MRMC study. It's a submission for a modification to a mechanical medical device, not a diagnostic imaging or AI-assisted system.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Study: No. This device does not involve an algorithm.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable in the context of a "ground truth" for diagnostic accuracy. The "truth" in this submission relies on demonstrating that the modified device's materials and design result in equivalent performance and safety to the already-cleared predicate device. This would typically involve engineering analysis, material testing (not detailed in this summary), and a comparison against the predicate's established characteristics.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. There is no "training set" as this is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable.
In summary:
This 510(k) submission (K031919) is for a modified external fixation device. The "study" proving the device meets acceptance criteria is primarily an engineering and regulatory comparison demonstrating substantial equivalence to a predicate device (K953406). The modification involves the addition of carbon fiber material for certain components. The acceptance criteria are implicitly met by showing that this material change does not alter the fundamental scientific technology, intended use, or safety/effectiveness of the device compared to the predicate. This is a common pathway for device modifications that do not introduce new risks or intended uses.
§ 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.