(16 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 modified self-drilling and blunt-tipped bone screws to the System. The components of the System may be manufactured from materials such as Aluminum, Stainless Steel, Cobalt Chrome, Carbon Fiber, and Titanium Alloy.
This looks like a 510(k) summary for a medical device modification, not a study report that would include detailed acceptance criteria and performance data as requested. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria through clinical studies in the way a new, innovative device might.
Therefore, many of the requested items (e.g., sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of document because the submission is for a modification of an already cleared device and relies on showing it's as safe and effective as the predicate.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of this 510(k) summary. This document asserts substantial equivalence, meaning the modified device performs comparably to the predicate device, rather than fulfilling specific, novel performance criteria demonstrated through new testing. The "acceptance criteria" here are essentially "is substantially equivalent to the predicate device."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to EBI® XFIX® DFS® System (K953406) in: | The modified EBI® XFIX® DFS® System is fabricated from the same materials. |
| - Materials | The modified EBI® XFIX® DFS® System has the same indications for use. |
| - Intended Use | The bone screw clamps are designed for attachment to bone screws, similar to the predicate. |
| - Function (specifically, bone screw clamps) | The additional component is provided non-sterile, like components of the predicate. |
| - Sterility (of additional component) | There are no significant differences in intended use, materials, and function. |
2. Sample Size for the Test Set and Data Provenance
Not applicable. This is a 510(k) for a device modification (addition of modified self-drilling and blunt-tipped bone screws). No new clinical test set or data provenance is detailed, as the primary argument is substantial equivalence to a previously cleared device. New clinical data is typically not required for such modifications unless there are significant changes to the intended use or technology that raise new safety or effectiveness concerns.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No new test set requiring expert ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable. No new test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. This document does not describe any MRMC study. These types of studies are more common for diagnostic imaging AI devices, which is not what this device is.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done
Not applicable. This is a physical external fixation system, not an algorithm, so "standalone performance" in the AI sense does not apply.
7. Type of Ground Truth Used
Not applicable. As no new clinical study data is presented, no ground truth types are mentioned. The ground for approval here is the previously cleared predicate device.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or software device that utilizes a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device, not an AI or software device that utilizes a training set and ground truth.
§ 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.