(29 days)
The EBI® XFIX® Vision® Fixation 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 external fixation components and implantable bone screws. The EBI® XFIX® Vision 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® Vision® Fixation System is attached to the shanks of the bone screws. This submission is for the additional rod sizes to the existing System. The intended use and fundamental scientific technology have not changed from the previously cleared submission.
This is a 510(k) Premarket Notification for a medical device modification, not an AI/ML device. Therefore, the request for information on acceptance criteria and study details related to device performance in the context of an AI/ML system (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this document.
The document describes a "Special 510(k) Device Modification" for the EBI® XFIX® Vision® Fixation System. This type of submission is typically for minor changes to an already legally marketed device where the modifications do not significantly alter the fundamental scientific technology or intended use.
Here's a breakdown of what the document does provide, structured to address relevant parts of your query, while explicitly stating where AI/ML-specific details are not present:
Acceptance Criteria and Study for K040833: EBI® XFIX® Vision® Fixation System
This submission is for a modification (additional rod sizes) to an existing external fixation system. The primary "acceptance criteria" and "study" for this type of submission revolve around demonstrating substantial equivalence to the predicate device, particularly regarding the modified components not raising new questions of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
For a device modification of this nature, the "acceptance criteria" are implicitly met by demonstrating that the new components (additional rod sizes) do not change the fundamental characteristics, materials, or intended use compared to the predicate device. The "reported device performance" is a demonstration of this equivalency.
| Acceptance Criterion (Implicit for device modification) | Reported Device Performance (as per submission) |
|---|---|
| Materials: Modified components fabricated from the same materials as predicate. | The additional EBI® XFIX® Vision® Fixation System components are fabricated from the same materials (Aluminum Alloy, Stainless Steel, Pyromet® 718, Carbon Fiber, and Titanium Alloy) as the components of the currently marketed EBI® XFIX® Vision® Fixation System. (Page 2) |
| Intended Use: Modified device maintains the same intended use as predicate. | The modified EBI® XFIX® Vision® Fixation System and the currently marketed EBI® XFIX® Vision® Fixation System are both indicated for 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 intended use has not changed. (Page 1 & 2) |
| Function/Design: Modified components function similarly to predicate components. | The bone screw clamps of the modified EBI® XFIX® Vision® Fixation System, like the bone screw clamps currently marketed, are designed for attachment to the bone screws. There are no significant differences between the modified system and the currently marketed system regarding function. (Page 2) |
| Sterilization: Modified device sterilization status is consistent with predicate. | The modified EBI® XFIX® Vision® Fixation System, like the currently marketed EBI® XFIX® Vision® Fixation System, is provided non-sterile. (Page 2) |
| Overall Substantial Equivalence: No significant differences in technological characteristics. | "There are no significant differences between the modified EBI® XFIX® Vision® Fixation System and the currently marketed EBI® XFIX® Vision® Fixation System. It is substantially equivalent to the predicate device with regard to intended use, materials, and function." (Page 2) FDA Conclusion: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..." (Page 3) |
The following points (2-9) are typically relevant for AI/ML device submissions, but are NOT applicable to this 510(k) for a physical medical device modification. This document does not describe an AI/ML algorithm or its evaluation.
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 is a physical device modification, not an AI/ML algorithm requiring a dataset for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. There is no "ground truth" establishment in the context of an AI/ML algorithm for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication process relevant to AI/ML performance is described.
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-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. No algorithm is present.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable. No ground truth for an AI/ML task is relevant here.
8. The sample size for the training set:
- Not Applicable. No training set for an AI/ML algorithm is relevant here.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or ground truth establishment for an AI/ML algorithm is relevant here.
§ 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.