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This submission describes a modification in intended use of the previously released Dall-Miles Homogeneous Cable (K945294). The original Homogeneous cable is intended to be used for spinal wiring, trochanter reattachment, sternotomy applications, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. Indications for the stabilization of bone graft material and for fracture fixation when used in conjunction with bone plates and screws have been added.

There have been no changes in the design, materials, manufacturing, or operational principles of the Dall-Miles Cable.

The provided text is a 510(k) summary for a medical device (Dall-Miles Homogeneous Vitallium® Cable) seeking approval for expanded indications. It is a regulatory submission focused on demonstrating substantial equivalence to predicate devices for these new indications.

**Crucially, this document does not describe:

• An AI/ML device.
• Acceptance criteria for algorithm performance.
• A study proving device performance against such criteria.**

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or AI-related study details.

The document discusses substantial equivalence for new intended uses of an existing physical device (a bone fixation cable), not the performance of a diagnostic or predictive algorithm.

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