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The FreeFix Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.

The FreeFix Forearm Plating System is comprised of plates, screws and specific instrumentation. The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.

The provided document is a 510(k) premarket notification letter and summary for the Skeletal Dynamics FreeFix Forearm Plating System. This document DOES NOT contain information about acceptance criteria and study that proves the device meets the acceptance criteria in the format requested.

The document states:

• "Mechanical testing, which established equivalency, includes ASTM F543-23, Standard Specifications and Test Methods for Metallic Bone Screws. All acceptance criteria were met, and the FreeFix Forearm Plating System performed better than its predicate device."

However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used or their qualifications.
• Adjudication method.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

This document focuses on establishing substantial equivalence to a predicate device based on mechanical testing (ASTM F543-23) for bone screws and does not describe clinical performance studies with human readers or AI.

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