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The DynaNail™ Mini Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.

The proposed DynaNail™ Mini is a sterile, single use titanium device with an additional internal Nitinol compressive element for use in midfoot and hindfoot reconstruction. The DynaNail™ Mini's titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the joints post-operatively. The DynaNail™ Mini is available in multiple diameters and lengths to accommodate variations in patient anatomy. The DynaNail™ Mini is implanted with a deployment frame and fixation screws. The fixation screws are single use titanium headless screws. These are available in various lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.

This is a 510(k) premarket notification for a medical device (DynaNail Mini) and therefore does not include detailed information about clinical studies, acceptance criteria, or ground truth establishment for AI/ML device performance. This document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, materials, and mechanical performance testing, rather than reporting on a study demonstrating clinical performance against acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred from the document:

1. A table of acceptance criteria and the reported device performance:

The document mentions "Engineering analysis and mechanical performance testing (Pull-out per ASTM F543) was performed." and "The test results and analysis demonstrate substantial equivalent performance to the predicate devices." It also states "Pyrogenicity testing was conducted per ANSI/AAMI ST72 for the worst case largest DynaNail™ system, confirming the most loaded device scenario meets the limit of 20EU. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011."

However, the specific acceptance criteria (e.g., "pull-out strength X N or greater") and the exact reported performance values are not provided in the text. The only specific acceptance criterion mentioned is for pyrogenicity: "confirmi[ng] the most loaded device scenario meets the limit of 20EU."

2. Sample size used for the test set and the data provenance: Not applicable. This document describes a mechanical device, not an AI/ML system tested on a dataset of patient information.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be its mechanical properties and biological compatibility, which are assessed through engineering analysis and laboratory testing (e.g., ASTM F543, ANSI/AAMI ST72), not clinical data from patients.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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