(27 days)
The EBI® XFIX® Access™ Pelvic Fixator and EBI® XFIX® DFS® system are 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® Access™ Pelvic Fixator System has not changed the Indications for Use or fundamental scientific technology of the previous cleared system. The system consists of external fixation components and implantable bone screws. The EBI® XFIX® Access™ Pelvic Fixator 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® Access™ Pelvic Fixator System is attached to the shanks of the bone screws. This submission is for the use of a Break-Away pelvic screw (clamp screw).
The provided text is a 510(k) Summary for the EBI® XFIX® Access™ Pelvic Fixator. This document is a premarket notification for a medical device and is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and results as one might find for a novel diagnostic or AI-driven device.
Based on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Requirements Met ("device complies with applicable standards and meets all of its functional requirements") | Testing comparing modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements. |
| Technological Characteristics Substantially Equivalent ("no significant differences between the EBI® XFIX® Access™ Pelvic Fixator with breakaway clamp screw and other currently marketed external fixation systems... substantially equivalent to the predicate devices in regards to intended use, materials and function") | The device was found to be substantially equivalent to predicate devices in regards to intended use, materials, and function. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes no clinical test set in the way typically seen for performance studies of AI or diagnostic devices. The testing mentioned appears to be engineering or functional testing of the device itself and its modifications, not a study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth based on expert review of a test set is mentioned.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring expert adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or reported. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to this mechanical external fixator.
6. Standalone Performance Study (Algorithm Only):
No standalone performance study of an algorithm was conducted or reported. This device is a mechanical external fixation system.
7. Type of Ground Truth Used:
Not applicable. The "ground truth" for this device's acceptance seems to be adherence to applicable standards and successful functional testing of its mechanical properties, rather than diagnostic accuracy against a clinical reference standard.
8. Sample Size for the Training Set:
Not applicable. This document pertains to a mechanical medical device, not an AI or machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is relevant to this device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document states: "Testing comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements."
This indicates that the "study" was likely engineering or functional testing to confirm that the changes (specifically the "Break-Away pelvic screw (clamp screw)") did not negatively impact the device's performance and that it continued to meet established requirements for external fixation devices. No clinical study with patient data or expert review is described as part of this 510(k) submission for substantial equivalence. The primary evidence for acceptance is the demonstration of substantial equivalence to a legally marketed predicate device through engineering and functional testing.
§ 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.