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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

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.

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