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The Steinmann Pins are intended to be used in conjunction with a compatible Stryker external supporting frame for stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

The Kirschner Wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, and as guide wires in hip pinning, and as fracture fixation devices in certain other small bone fractures.
• For use as guide wires in hip pinning procedures,
• For use in aligning and reducing long bone fractures,
• For use in securing temporary stabilization of bone fractures such as olecranon fractures; patella fractures; tibia plateau fractures; small hand and foot bone fractures; humeral, radial and ulnar fractures.
• For use with cerclage wire/cable in treating greater trochanter fractures.

The Steinmann Pins and Kirschner Wires are designed for multiple purposes which allow the use in skeletal traction for alignment and reduction of bone fractures, function as fracture fixation devices in certain fractures, preliminary fixation for implants (for example plates) and for evaluation of screw trajectories or guidance for cannulated instruments.

The Steinmann Pins and Kirschner Wires are available in different dimensions and provide several design features. The dimensions vary in diameter and length. The design features are the tip geometry which can be a three-sided trocar tip or a two-sided diamond tip on either one end or both ends of the pin. Additionally, some pins are threaded.

The pins and wires are made from stainless steel (1.4441).

The provided document is a 510(k) Summary for Steinmann Pins and Kirschner Wires. It states that clinical data and conclusions were not needed to demonstrate substantial equivalence to the predicate devices. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for a clinical study is not available in this document.

The document primarily focuses on non-clinical performance data and relies on equivalence to predicate devices and adherence to international standards.

Here's a breakdown of the available information relevant to performance:

1. Table of Acceptance Criteria and Reported Device Performance:

Since clinical data was not required, there isn't a table of specific clinical acceptance criteria vs. device performance. Instead, the "Performance Data (Nonclinical)" section details how substantial equivalence was demonstrated.

2. Sample size used for the test set and the data provenance:

• Not applicable (N/A): No clinical test set or data provenance is mentioned as clinical data was not needed. The assessment was based on non-clinical performance and equivalence to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A: No clinical test set or ground truth established by experts is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• N/A: No clinical test set or adjudication method is mentioned.

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:

• N/A: The device is a physical medical device (pins and wires), not an AI diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• N/A: The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• N/A: For the substantial equivalence determination, the "ground truth" was established through comparison to legally marketed predicate devices and adherence to relevant non-clinical performance standards.

8. The sample size for the training set:

• N/A: No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• N/A: No training set is mentioned.

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