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The ULTiMAX™ brand Distal Radial (Volar) Locking Plate System is indicated for single use to stabilize distal fractures of the radius.

ULTIMAX™ Distal Radial (Volar) Locking Plate System

Unfortunately, the provided text is a 510(k) clearance letter from the FDA for a medical device called the "ULTIMAX™ Distal Radial (Volar) Locking Plate System." This document primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device.

It does not contain information about:

• Specific acceptance criteria for device performance (e.g., in terms of biomechanical properties, clinical outcomes, etc.).
• Any detailed study that proves the device meets such criteria. The "substantial equivalence" determination is typically based on comparing the new device's design, materials, and intended use to a device already on the market (the predicate device), rather than requiring new, comprehensive performance studies with acceptance criteria.
• Sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how training ground truth was established.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details based on the given document. The letter indicates that the device is cleared for marketing based on its equivalence to previously approved devices, but it does not detail the specific performance metrics or studies you're asking for.

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