(48 days)
The EBI XFIX DFS Rail System is a unilateral external fixation device intended for use in the treatment of bone conditions including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction 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 EBI XFIX DFS Rail 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 Rail System is attached to the shanks of the bone screws. This submission is for the addition of a carbon fiber (radiolucent) Rail to the System.
This document is a 510(k) Premarket Notification for the EBI XFIX DFS Rail System. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily for the addition of a carbon fiber (radiolucent) Rail. This type of submission, for a physical medical device, does not typically involve the kinds of studies and data points (like AI performance metrics, expert ground truth, training/test set sizes) that would be relevant for an AI/ML-based device.
Therefore, many of the requested details about acceptance criteria for AI performance, study methodology, expert consensus, and data provenance are not applicable to this 510(k) submission.
Here's a breakdown of what can be extracted from the provided text, aligning with the request where possible, and noting where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated for AI Performance) | Reported Device Performance (as demonstrated for substantial equivalence) |
|---|---|
| Substantial Equivalence to Predicate Devices: | - Indicated for the same bone conditions (limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute/gradual multiplanar correction, etc.). |
| - Intended Use | - Provided non-sterile. |
| - Sterility/Provision | - Fabricated from the same materials (titanium alloy, stainless steel, aluminum, carbon fiber reinforced epoxy, Pyromet® 718). |
| - Materials | - No significant differences in function or mechanical integrity compared to the predicate EBI XFIX DFS Rail System (K991941, K000083, K010437) and EBI XFIX Vision Fixation System (K993886, K014194, K020141). |
| - Function and Mechanical Integrity |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission is for a physical medical device (an external fixation system), not an AI/ML diagnostic device that would typically have test sets of data. The "testing" referred to for this device would be mechanical and material testing to ensure structural integrity and biocompatibility, not performance evaluation against a dataset for diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As this is not an AI/ML diagnostic device, there is no "ground truth" establishment in the context of expert consensus on image interpretation or similar. The "experts" involved would be engineers and material scientists for device design and testing, and potentially orthopedic surgeons for clinical input on device use.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set adjudication method for AI performance is relevant to this device.
5. 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. MRMC studies are used for evaluating diagnostic performance with AI assistance. This device is not an AI diagnostic tool and does not involve human "readers" or AI assistance in that context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For this device, "ground truth" would relate to accepted engineering standards for device strength, material properties, and biocompatibility, as well as established clinical efficacy for external fixation devices. It's not typically a "ground truth" in the diagnostic data sense.
8. The sample size for the training set:
- Not Applicable. This device does not use an AI training set.
9. How the ground truth for the training set was established:
- Not Applicable. This device does not use an AI training set, so no ground truth for it was established.
Summary of What This Document Does Provide:
The provided 510(k) summary explicitly states that the submission is for the "addition of a carbon fiber (radiolucent) Rail to the System." The core of the justification for market clearance (substantial equivalence) relies on:
- Identical Intended Use: The proposed device and predicate devices are used for the same general orthopedic conditions requiring external fixation.
- Similar Materials: The new component uses carbon fiber, which is explicitly listed as a material that can be used in the system, alongside other materials common to the predicate devices.
- Comparable Function and Mechanical Integrity: The submission asserts that there are "no significant differences" in these aspects, implying that mechanical testing (which is standard for all medical devices but not detailed here) would have been performed to support this claim.
- Non-sterile Provision: Both the proposed and predicate devices are provided non-sterile, indicating a consistent approach to sterilization (likely by the end-user or facility).
The FDA's letter (K021031) confirms that a substantial equivalence determination was made based on these comparisons to predicate devices.
§ 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.