(127 days)
The S.E.A.L. Fracture Fusion Tube is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.
The S.E.A.L. Fracture Fusion Tube provides a solution for fractures and for lengthening of small bones. The system allows controlled compression / distraction and early weight bearing. The articulating pin clamps allow adjustment around three axes and linear translation so that it can be used for comminuted intra-articular fractures or arthrodesis of the fixator design enables pins to be located in multi-planar arrangements, allowing the frame to be built around the fractures in the hand or foot.
The S.E.A.L. Fracture Fusion Tube is a medical device for external fixation of fractures and reconstruction of small bones. The device did not undergo clinical studies to prove its performance. Instead, its substantial equivalence to predicate devices was claimed based on non-clinical testing.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to predicate devices in terms of mechanical safety and performance, as demonstrated by ASTM F1541-02 Annex 7 testing. | The analysis indicates that the S.E.A.L. Fracture Fusion Tube is equivalent to predicate devices. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not applicable. No clinical test set or human data was used.
- Data Provenance: Not applicable. The study involved non-clinical mechanical testing, not a test set derived from patient data.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. Ground truth from experts is not relevant for non-clinical mechanical testing.
4. Adjudication Method
- Not applicable. There was no test set requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done.
6. Standalone Performance Study
- A standalone (algorithm only without human-in-the-loop performance) study was not applicable as this is a medical device with no AI component.
- Non-clinical testing following ASTM F1541-02 Annex 7 was performed to assess the mechanical safety and performance of the device.
7. Type of Ground Truth Used
- Ground Truth Type: Mechanical testing results against established industry standards (ASTM F1541-02 Annex 7) and comparison to predicate devices. The "ground truth" here refers to the engineering and material science principles governing external fixators.
8. Sample Size for Training Set
- Not applicable. No training set was used for this device as it does not involve machine learning or AI.
9. How Ground Truth for Training Set was Established
- Not applicable. No training set was used.
§ 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.