(25 days)
The EBI XFIX® DFS® Metaphyseal Correction 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 EBI XFIX® DFS® Metaphyseal Correction System has not changed the Indications for Use or fundamental scientific technology of the previously cleared system. The system consists of external fixation components and implantable bone screws. The EBI XFIX® DFS® Metaphyseal Correction 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® Metaphyseal Correction System is attached to the shanks of the bone screws. This submission is for additional components.
The provided text is a 510(k) Summary for the EBI XFIX® DFS® Metaphyseal Correction System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data like a novel device would. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this document.
Here's what can be inferred and what is explicitly not mentioned in the document based on your request:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Substantial Equivalence to predicate device | "There are no significant differences between the EBI XFIX® DFS® Metaphyseal Correction System and other currently marketed external fixation systems. It is substantially equivalent to the predicate devices in regards to intended use, materials, and function." | The primary "acceptance criterion" for a 510(k) submission like this is substantial equivalence to a legally marketed predicate device. The document explicitly states this is met. Specific performance metrics like accuracy, sensitivity, or specificity are not part of this type of submission for this device. |
Study Details (Based on the 510(k) Summary)
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Sample size used for the test set and the data provenance: Not applicable. This 510(k) submission does not describe a performance study with a test set. It relies on demonstrating substantial equivalence to a predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance study with a test set requiring expert ground truth is described.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No performance study requiring adjudication is described.
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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-assisted device, and no MRMC study is described.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical external fixation device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a 510(k) for a physical device demonstrating substantial equivalence. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.
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The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm.
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How the ground truth for the training set was established: Not applicable. As above, this is not an AI/ML device.
Summary of Device and 510(k) Content:
The EBI XFIX® DFS® Metaphyseal Correction System is an external fixation device used for conditions like leg lengthening, osteotomies, arthrodesis, and fracture fixation. The 510(k) submission (K001358) states that it has not changed the Indications for Use or fundamental scientific technology of the previously cleared system (EBI XFIX® DFS® System). The primary argument for clearance is that the device is substantially equivalent to its predicate device in terms of intended use, materials (titanium, stainless steel, aluminum), and function. This type of submission typically does not include new clinical performance studies or specific accuracy/performance metrics, as it relies on the established safety and effectiveness of the existing predicate device. The submission explicitly states there are "no significant differences."
§ 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.