(25 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 components to the existing System. The intended use and fundamental scientific technology have not changed from the previously cleared submission.
Here's an analysis of the provided text regarding the EBI® XFIX® Vision™ Fixation System, focusing on acceptance criteria and supporting studies.
Based on the provided document, there is NO information regarding acceptance criteria or a study proving the device meets them.
This 510(k) submission (K011711) is a Special 510(k) Device Modification for the EBI® XFIX® Vision® Fixation System. This type of submission is used when changes are made to a previously cleared device that do not affect its fundamental scientific technology or intended use. The primary purpose of such a submission is to demonstrate that the modified device remains substantially equivalent to the predicate device.
Therefore, the document focuses on comparing the modified device to its predicate (EBI® XFIX® Vision® Fixation System K993886) in terms of materials, intended use, and function, rather than establishing new performance criteria or presenting a new clinical study.
Here's a breakdown of why the requested information is absent:
- A table of acceptance criteria and the reported device performance: Not present. The document asserts substantial equivalence, meaning it relies on the predicate device's established performance without defining new criteria for the modified components.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, no clinical study for this modification is reported.
- 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.
- 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 a mechanical fixation device, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does state and imply is relevant to its intended purpose:
- Predicate Device: EBI® XFIX® Vision® Fixation System (K993886)
- Key Argument for Substantial Equivalence:
- Same materials (e.g., stainless steel, titanium alloy).
- Same intended use (treatment of bone conditions like leg lengthening, osteotomies, arthrodesis, fracture fixation).
- Similar design elements (bone screw clamps designed for attachment to bone screws).
- Same non-sterile provision.
- Conclusion by FDA: The FDA determined the device is "substantially equivalent" to predicate devices, allowing it to be marketed. This determination is based on the information provided in the 510(k) notification, which emphasizes the lack of significant differences from the previously cleared predicate.
In summary, this document is a regulatory filing focused on demonstrating substantial equivalence for a device modification, not on presenting novel performance data or acceptance criteria for a new device.
§ 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.