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Orthopaedic fixation pins and wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system.

Orthopaedic fixation pins and wires are metal pins for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implantation through the skin so that traction may be applied to the skeleton system. To ensure the multi-use of these devices, many different models are available. The differences can be as follows: Diameter: from 0.6 up to 6.35mm (0.020 up to 0.250 inch) Length: from 60 up to 500 mm (2.36 up to 19.69 inch) Tips: diamond or trocar Point, round, flat, with or without 3- or 4- shank ends, with or without spherical shape. Surface: complete or partial smooth and / or threaded, with or without threading cutter.

This document is a 510(k) premarket notification for an orthopedic device (Kirschner Wires and Pins), not a study evaluating software or AI performance. Therefore, it does not contain information related to acceptance criteria or studies proving a device meets acceptance criteria in the manner requested (e.g., using AI, ground truth, expert consensus, sample sizes for training/test sets).

The document is a submission to the FDA to demonstrate substantial equivalence to existing legally marketed devices, which is a different type of regulatory pathway than one that would involve performance studies for AI/software.

Specifically, the document does not include any of the following:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, data provenance, or details of retrospective/prospective studies.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Information about a standalone (algorithm only) performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

Instead, this document focuses on:

• Device Name and Classification: Identifying the device as Orthopaedic Fixation Pins and Wires (Kirschner Wire) and classifying it under specific FDA product codes and regulations.
• Substantial Equivalence: Demonstrating that the device is substantially equivalent to legally marketed predicate devices (Störk Kirschner Wires and Steinmann Pins, and Teleflex KMedic Internal/External Fixation Devices) based on design, dimensional, and material characteristics.
• Device Description: Detailing physical characteristics like diameter, length, tips, and surface.
• Intended Use: Stating that the pins and wires are for fixation and stabilization of bone fractures or as guidance for implant insertion.
• Regulatory Conclusion: Concluding that the device is substantially equivalent to existing devices based on 510(k) summaries and information provided.

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