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The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, malunions, replantations, and fusions of short bones and small fragments of bone including the hand, wrist, foot, and ankle. The minifrag system is also intended for reduction and stabilization of non-load bearing long bone fragments.

The Tyber Medical Mini-frag System is not for Spinal Use.

The Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System consists of titanium plates (straight and T-plate) and locking /non-lockingscrews (1.3mm) and are offered in a range of configurations to accommodate patient anatomy. The plates and screws are non-sterile.

This document describes the FDA's decision regarding Tyber Medical, LLC.'s Tyber Medical Anatomical Plating System and does not contain information about the acceptance criteria or study details for a software device. The information provided is for a traditional metallic bone fixation appliance and accessories, which typically involve mechanical testing rather than AI/software performance studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study that proves a device meets the acceptance criteria based on the provided text, as the text describes a physical medical device and not a software device with associated AI/ML performance metrics.

The provided text only mentions:

• Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
  • "The mechanical testing for the subject devices were performed in conformance with the FDA currently-recognized version of ASTM F382 for metallic bone plates and ASTM F543 for bone screws."
  • "No clinical testing was performed."

This indicates that the evaluation was based on mechanical engineering standards for physical components, not on a study with AI performance metrics, ground truth, expert readers, or sample sizes related to an AI model's output.

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