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The Tyber Medical BioTy™ Nanotopography Trauma Screw, TyFix Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion appropriate for the size of the device. The screw is intended for single use only.

General trauma screw for compression and fixation of bone. The BioTy™ Nanotopography provides a microscopic roughened surface with nano-scaled features. The screws will be provided sterile in both solid and cannulated form, made of from titanium and stainless steel.

This document describes the regulatory submission for a medical device (bone screw) and does not contain information about Artificial Intelligence (AI) or machine learning (ML) device performance, acceptance criteria for AI/ML, or studies involving AI/ML.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size used for an AI/ML test set or data provenance.
• Number of experts used to establish ground truth for an AI/ML test set.
• Adjudication method for an AI/ML test set.
• MRMC comparative effectiveness study results for AI/ML.
• Standalone performance for an AI/ML algorithm.
• Type of ground truth used for an AI/ML device.
• Sample size for training set for an AI/ML device.
• How ground truth for an AI/ML training set was established.

The provided text pertains to a traditional 510(k) submission for a mechanical medical device (Tyber Medical BioTy™ Nanotopography Trauma Screw, TyFix Screw). The acceptance criterion mentioned is for mechanical and material testing (Pull out Test per ASTM F543, Static Torsion Test per ASTM F543, and Pyrogenicity testing) and states that the device "met the acceptance criteria" for these physical tests. It explicitly states "Clinical Test Summary: n/a".

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