(30 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 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. This submission is for the availability of a Central Body Variable Clamp.
This submission is a 510(k) premarket notification for a medical device, the EBI® XFIX® DFS® System. This type of submission relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical studies to prove safety and effectiveness. Therefore, the information typically gathered from such studies (like detailed acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) is not present in this document for the new device.
The document focuses on comparing the new device to a predicate device (EBI® XFIX® DFS® System, K953406) based on materials, intended use, and function.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the 510(k) summary. For a 510(k) submission, the "acceptance criteria" for the new device are typically met by demonstrating that it is substantially equivalent to a predicate device that has already met its own safety and effectiveness criteria. The document explicitly states:
- "There are no significant differences between the proposed EBI® XFIX® DFS® System and the currently marketed EBI® XFIX® DFS® System. It is substantially equivalent to the predicate device with regard to intended use, materials, and function."
Therefore, the performance of the new device is assumed to be equivalent to the predicate, and no new performance data or specific acceptance criteria are presented for it.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided. This 510(k) submission is not based on a clinical study of the new device that would involve a test set. It relies on a comparison to an existing predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable and not provided. As no new clinical study was conducted for this 510(k) anlaysis, there was no test set requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable and not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This 510(k) submission is for an external fixation system, not a device typically evaluated with MRMC studies (which are common for imaging and diagnostic AI).
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone study was not done. This device is a mechanical external fixation system and does not involve algorithms or AI.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
This information is not applicable and not provided for the new device. The "ground truth" for a 510(k) submission of this type is essentially the established safety and effectiveness of the predicate device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. As this is a mechanical medical device, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided.
Summary of Device and 510(k) approach:
The EBI® XFIX® DFS® System is an external fixation device. This 510(k) submission (K013739) is for a modification to an existing, legally marketed device (K953406) by introducing a "Central Body Variable Clamp."
The basis for regulatory clearance (510(k)) is by demonstrating "substantial equivalence" to the predicate device, not by conducting new clinical trials for safety and effectiveness that would generate performance data against specific acceptance criteria. The submission explicitly states equivalence in "intended use, materials, and function."
Therefore, the document does not contain the detailed study information you've requested as would be found in a submission requiring de novo clearance or a premarket approval (PMA) based on extensive clinical data.
§ 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.