(94 days)
The EBI® XFIX® OptiROM® Knee Fixator 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 EBI® XFIX® OptiROM® Knee Fixator is a module which is used in conjunction with the currently marketed EBI® XFIX® DFS® System. The EBI® XFIX® OptiROM Knee Fixator has not changed the Indications for Use or the fundamental scientific technology of the previously cleared System. The System consists of external fixation components and implantable bone screws. The 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 System is attached to the shanks of the bone screws.
The provided text is a 510(k) summary for the EBI® OptiROM® Knee Fixator. It describes the device, its intended use, and states that it is substantially equivalent to a predicate device. However, it does not contain information on acceptance criteria or a study proving the device meets those criteria.
Specifically, the document states: "There are no significant differences between the EBI® XFIX® OptiROM® Knee Fixator and the currently marketed EBI® XFIX® DFS® System. It is substantially equivalent* to the predicate device in regards to intended use, materials, and function." The asterisk refers to a disclaimer about substantial equivalence not being an admission in patent infringement litigation.
This indicates that the submission relies on the substantial equivalence principle, comparing the new device to a previously cleared one, rather than presenting new performance data against specific acceptance criteria.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample size used for the test set and the data provenance: No new test data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test data is presented.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no new test data is presented.
- 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. The device is a mechanical fixator, not an AI-based diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a mechanical fixator, not an AI algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no new test data is presented.
- The sample size for the training set: Not applicable as no AI/machine learning component is described.
- How the ground truth for the training set was established: Not applicable as no AI/machine learning component is described.
§ 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.