(88 days)
The EBI® XFIX® DFS® System is 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 DFS 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 System is attached to the shanks of the bone screws. The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of carbon fiber material for the Straight Clamps, modification to the Carbon Ankle Clamp, and modification to the Carbon T-Clamp.
The provided text is a 510(k) Summary for the EBI® XFIX® DFS® System, an external fixation device. It outlines the device's description, intended use, materials, and comparison to predicate devices, focusing on demonstrating substantial equivalence to previously cleared devices.
Crucially, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way that would typically be described for a diagnostic AI/ML device.
The 510(k) process for this type of medical device (external fixation system) primarily relies on demonstrating substantial equivalence to a predicate device. This means showing that the new device has the same intended use, fundamental scientific technology, and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness. The "study" here is essentially the comparison and justification of equivalence to predicate devices, rather than a clinical performance study with defined metrics.
Therefore, many of the requested sections about acceptance criteria, performance metrics, ground truth, sample sizes for test/training sets, experts, and adjudication methods are not applicable to this type of submission.
Here's a breakdown based on the provided text, highlighting what is and isn't available:
Acceptance Criteria and Device Performance Study for EBI® XFIX® DFS® System
This 510(k) submission (K040935) seeks marketing clearance for a modified EBI® XFIX® DFS® System by demonstrating substantial equivalence to predicate devices. The "study" to meet this requirement is a comparison of the new device's characteristics to those of predicate devices, asserting that the modifications do not introduce new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a mechanical device submission demonstrating substantial equivalence, rather than a diagnostic AI/ML device, there are no specific performance-based acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics in the traditional sense. The "acceptance criteria" here implicitly revolve around demonstrating that the modified device's materials, intended use, and function are comparable to the predicate devices.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (as described in 510(k) Summary) |
|---|---|
| Intended Use: Same as predicate devices. | "The intended use and fundamental scientific technology have not changed from the previously cleared submission." |
| "The modified EBI XFIX DFS System and the currently marketed EBI XFIX DFS 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." | |
| Material: Same or equivalent engineering materials for intended function. | "This submission is only for the addition of carbon fiber material for the Straight Clamps, modification to the Carbon Ankle Clamp, and modification to the Carbon T-Clamp." |
| "The components of the System may be manufactured from materials such as aluminum, stainless steel, titanium alloy, and carbon fiber." | |
| "The modified EBI XFIX DFS System is fabricated from the same materials as the components of the currently marketed EBI XFIX DFS Fixation System (implies similar materials, and specifically lists carbon fiber as an addition)." | |
| Technological Characteristics/Functionality: Similar to predicate devices, with no significant differences impacting safety/effectiveness. | "The bone screw clamps of the modified EBI XFIX DFS System, like the bone screw clamps currently marketed in the EBI XFIX DFS System, are designed for attachment to the bone screws." |
| "There are no significant differences between the modified EBI XFIX DFS System and the currently marketed EBI XFIX DFS System. It is substantially equivalent to the predicate device with regard to intended use, materials, and function." | |
| Sterilization State: Consistent with predicate devices. | "The additional component of the EBI XFIX DFS System, like the components of the currently marketed EBI XFIX DFS System, is provided non-sterile." |
2. Sample size used for the test set and the data provenance
Not applicable. This is not a study involving a test set of data like an AI/ML algorithm. The "test" for substantial equivalence is a comparison of specifications and intended use against existing cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for diagnostic performance studies is not relevant here. The ground truth for regulatory clearance in this context is the safety and effectiveness of the predicate devices.
4. Adjudication method for the test set
Not applicable. No test set for diagnostic performance.
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 an external fixation system, not a diagnostic imaging or AI algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (external fixation system), not an algorithm.
7. The type of ground truth used
For the purpose of this 510(k) submission, the "ground truth" is that the predicate devices are legally marketed and considered safe and effective for their intended use. The submission aims to establish that the modified device is equally safe and effective due to substantial equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.