(35 days)
The EBI® DynaFix® Vision® FootPlate System intended for use in the treatment of the HDP by na in and other osteotomies, arthrodesis, fracture fixation, and other bone bond tone able to treatment by the use of the external fixation modality.
External Fixation Device
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conforms to design specifications | "the FootPlate System conforms to its design specifications." |
| Functions as intended | "In all instances, the FootPlate System functioned as intended" |
| Test results obtained as expected | "the test results obtained were as expected." |
| Mechanically sound (static) | Mechanical testing verified static design specifications. |
| Mechanically sound (fatigue) | Mechanical testing verified fatigue design specifications. |
| Safe and effective as predicate devices (DFS and Vision Systems) | "Performance data demonstrate that the FootPlate System is as safe and effective as the DFS System and Vision System." |
| No new issues of safety or effectiveness compared to predicate devices | "The minor technological differences... raise no new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes mechanical testing rather than a study involving human or animal subjects and data provenance. For the mechanical testing performed:
- Sample Size for Test Set: Not explicitly stated as a number of devices. The study mentions that an "Engineering Rationale was written to demonstrate that the mechanical testing conducted represented the worst case construct and why further testing on the additional sizes of FootPlate System components is unnecessary." This implies that representative samples of the FootPlate System, likely the worst-case configuration, were tested.
- Data Provenance: Not applicable as this was mechanical testing of a medical device, not a clinical study on patients.
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. Ground truth as typically understood in studies involving expert review (e.g., medical image analysis) is not relevant for this type of mechanical device testing. The "ground truth" here is the physical performance and adherence to engineering specifications, which is assessed through standardized mechanical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in studies where human experts are making judgments that need to be reconciled (e.g., clinical diagnoses). This was mechanical testing, where performance is measured objectively.
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 a 510(k) summary for a mechanical external fixation device, not a diagnostic or AI-powered device. Therefore, an MRMC study or AI assistance evaluation is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is its physical and mechanical properties measured against predefined design specifications and engineering standards. This includes:
- Static design specifications
- Fatigue design specifications
- Expected functional performance
These aspects are evaluated through controlled mechanical testing.
8. The sample size for the training set
Not applicable. This is a mechanical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.