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The Operativ Kirschner wires and Steinmann pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

The Operativ internal/external fixation devices consist of various fixation pins and wires for in unilateral internal/external fixation. The various lengths, sizes and end configurations are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference. Calibrated wires provide etched markings every 1/2 inch. All Operativ internal/external fixation devices included in this submission are manufactured from stainless steel and will be offered non-sterile.

The provided document is a 510(k) summary for medical devices (Kirschner wires and Steinmann pins). It states that the determination of substantial equivalence was based on a detailed description and conformance with voluntary standards, and that "Based upon the similarities in materials and design to the predicate devices, the technological characteristics are sufficient to support a determination of substantial equivalence."

This type of submission does not include the kind of performance study data and acceptance criteria typically found for software or AI/ML-based devices. Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document explicitly states that the substantial equivalence was determined based on material and design similarities to predicate devices, not on performance data from a clinical or analytical study.

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