(30 days)
The EBI® XFIX® DFS® Metaphyseal 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 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 the addition of a locking set screw to the system.
This 510(k) premarket notification for the EBI XFIX® DFS® Metaphyseal Correction System does not contain the acceptance criteria or a study proving that the device meets acceptance criteria in the typical sense of a clinical or performance study for a diagnostic AI device.
Instead, this document is a premarket notification (510(k)) for a medical device that has not significantly changed from its predicate device. For such devices, the primary "acceptance criterion" is Substantial Equivalence to a legally marketed predicate device. The "study" that proves this is essentially the submission itself, which details the device's characteristics and compares them to the predicate.
Here's why many of your requested points are not applicable to this type of submission:
- This is not an AI device. The submission describes an external fixation device, which is a physical implant, not a software algorithm. Therefore, concepts like "test set," "training set," "ground truth," "MRMC study," and "standalone algorithm performance" are not relevant.
- The "performance" is demonstrated through equivalence. For 510(k)s, especially for devices undergoing minor modifications or demonstrating direct substantial equivalence, extensive de novo performance studies as you might see for novel AI/diagnostic devices are typically not required. The "acceptance criteria" here are met by showing that the modified device is as safe and effective as the predicate.
Given this, I will answer the applicable questions based on the provided text, and explicitly state when a question is not applicable.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criterion (for 510(k) Substantial Equivalence) | Reported Device Performance / Assessment |
|---|---|
| Intended Use Equivalence | The EBI XFIX® DFS® Metaphyseal Correction System's Intended Use "has not changed" from the previously cleared system. It is intended for leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to external fixation. This is equivalent to the predicate device. |
| Technological Characteristics Equivalence | The device "has not changed the... fundamental scientific technology of the previously cleared system." The submission states, "There are no significant differences between the EBI XFIX® DFS® Metaphyseal Correction System and other currently marketed external fixation systems." The only change is "the addition of a locking set screw to the system." It is substantially equivalent to the predicate devices in regards to function. |
| Material Equivalence | The device materials ("titanium, stainless steel, and aluminum") are common for such devices and are equivalent to those used in the predicate devices. |
| Safety and Effectiveness | By demonstrating substantial equivalence in intended use, technological characteristics (with only a minor addition of a locking set screw), and materials to legally marketed predicate devices, the device is deemed to be as safe and effective as those legally marketed predicates. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..." This determination implies the device meets the necessary safety and effectiveness standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission is for a physical external fixation device and relies on demonstrating substantial equivalence to a predicate device, not on clinical performance data from a test set in the context of an AI/diagnostic study. There is no "test set" in the sense of patient data being analyzed by an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. As this is not an AI/diagnostic device, there is no "ground truth" established by experts for a test set. Substantial equivalence is determined by regulatory review and comparison to predicate devices, not by expert consensus on clinical data for the device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" or adjudication method relevant to this 510(k) submission.
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 is not an AI device or a diagnostic device where human reader performance with or without AI assistance would be studied.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For this type of 510(k) submission, the "truth" is established by the documented characteristics of the device and its predicate, along with regulatory guidelines, rather than by a specific clinical "ground truth" derived from patient data. The FDA's determination of substantial equivalence serves as the regulatory "truth" for market authorization.
8. The sample size for the training set
- Not applicable. This submission is not for an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no associated ground truth to establish.
§ 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.