(30 days)
The EBI® DynaFix® Diaphyseal Correction 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 EBI® DynaFix® Diaphyseal Correction System is a module which is used in conjunction with the currently marketed EBI XFIX DFS 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.
This 510(k) submission for the EBI® DynaFix® Diaphyseal Correction System primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and testing results against those criteria. Therefore, most of the requested information regarding study details is not present in the provided text.
Based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document does not specify quantitative acceptance criteria or report specific performance metrics for the device. The 510(k) relies on substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance
Not applicable. No performance study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No performance study requiring ground truth establishment is presented.
4. Adjudication method for the test set
Not applicable. No performance study data is presented.
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. This device is a mechanical external fixation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a mechanical external fixation system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No performance study requiring ground truth is presented.
8. The sample size for the training set
Not applicable. This device is a mechanical external fixation system, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This device is a mechanical external fixation system, not a machine learning model.
Summary of the Study and Acceptance Criteria (as per the provided text):
The provided 510(k) summary explains that the EBI® DynaFix® Diaphyseal Correction System is being marketed based on its substantial equivalence to a previously cleared device, the EBI® DynaFix® Diaphyseal Correction System (K021695).
The acceptance criteria for this type of submission are qualitative and focus on demonstrating that the new device has:
- Same intended use: The document explicitly states the intended use is "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," which is presumed to be the same as the predicate.
- Similar technological characteristics: The document states, "There are no significant differences between the EBI® DynaFix® Diaphyseal Correction System and other currently marketed external fixation systems. It is substantially equivalent to the predicate device in regards to intended use, materials, and function."
- Similar materials: The components "may be manufactured from materials such as titanium, stainless steel, aluminum, and Delrin®," implying these are common and similar to the predicate.
The "study" that proves the device meets the acceptance criteria is the comparison of the new device to the predicate device, as presented in section 7 of the 510(k) summary. This is a comparative analysis based on a review of specifications and attributes, rather than a clinical trial or performance study with quantitative results. The FDA's letter confirms that they "reviewed your Section 510(k) premarket notification... and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This determination is the "proof" for the acceptance criteria in this context.
§ 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.