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The SBi Titanium Threaded Pin is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

The SBi Titanium Threaded Pin consists of a set of titanium threaded pins for internal fixation. Each threaded pin has a machined groove that provides a "break-away" capability. The devices are supplied non-sterile and are available in various sizes diameters and lengths.

The provided text is a 510(k) summary for the SBi Titanium Threaded Pin, seeking clearance from the FDA. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study of device performance against specific acceptance criteria. Therefore, the information required to answer most of your questions is not typically found in this kind of regulatory submission.

Specifically, the document does not contain information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, or details on retrospective/prospective studies.
• Number or qualifications of experts used to establish ground truth for a test set.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance studies.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as another legally marketed device (the predicate device) and that it has the same technological characteristics or has different technological characteristics but does not raise new questions of safety and effectiveness. This is typically achieved through comparisons of materials, design, indications for use, and often bench testing to confirm mechanical properties, rather than clinical studies with ground truth established by experts.

Summary of available information from the provided text:

• Device Name: SBi Titanium Threaded Pin
• Manufacturer: Small Bone Innovations International, SA
• Intended Use: The SBi Titanium Threaded Pin is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
• Material: Ti-6Al-4V per ISO 5832-3
• Regulation Number: 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener)
• Regulatory Class: Class II
• Product Code: JDW
• Substantial Equivalence: Documentation is provided which demonstrates the SBi Titanium Threaded Pin to be substantially equivalent to other legally marketed devices.

To answer your initial request directly, the document explicitly states: "Documentation is provided which demonstrates the SBi Titanium Threaded Pin to be substantially equivalent to other legally marketed devices." This statement is the "study" that proves the device meets the "acceptance criteria" of substantial equivalence required for 510(k) clearance. However, the details of that "documentation" (e.g., bench tests, materials safety data, design comparisons) are not provided in this summary. There is no performance data in the traditional sense of diagnostic accuracy or clinical outcomes presented here, as it's not a clinical trial summary.

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