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The OsteoCoil™ Nitinol Compression System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of the small bones for wrist, hand, and foot.

This Traditional 510(k) is submitted to introduce the OsteoCoil™ Nitinol Compression System. The system consists of a 4.5mm, 6.5mm and 7.3mm screw available in 30mm in 5mm increment lengths and appropriate instrumentation to support implantation of the OsteoCol™ Nitinol Compression screws. The the OsteoCol™ Nitinol Compression System have the same technological characteristics as the predicate device, the Dynafuse Fixation System (K203595).

The provided text is related to a 510(k) premarket notification for the OsteoCoil™ Nitinol Compression System. It describes the device, its intended use, and a summary of non-clinical tests performed to demonstrate substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving device performance against such criteria in the context of a clinical or standalone performance study involving AI or human readers.

Instead, the document details physical and material properties testing for a medical implant (bone fixation fastener).

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not present in the provided text.

The closest information available is a list of non-clinical mechanical and material tests conducted to demonstrate substantial equivalence:

Non-Clinical Test Summary:

The following non-clinical tests were performed:

• ASTM F543:
  • Torsional Strength
  • Driving and Removal Torque
  • Axial Pullout Strength
  • Self-tapping Force
• ASRM F1264:
  • Bending Fatigue
  • Static 4Pt Bending
• ASTM F2129: Pitting Corrosion Testing
• ASTM F2004: Transformation Temperature Testing
• Additionally:
  • Extension and Compression Force Testing
  • Bacterial endotoxin testing based on an endotoxin limit of 20EU/device per ANSI/AAMI ST72:2011
  • Applicable testing per ISO 10993

Conclusion from the document: "The results demonstrate that the OsteoCoil™ Nitinol Compression System is substantially equivalent to the legalicate devices."

This document focuses on the mechanical and material safety/performance of a physical medical device, not a software or AI-driven diagnostic tool. Therefore, the concepts of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity), ground truth establishment by experts, adjudication, or AI performance studies are not applicable here.

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