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Normed Mini External Fixator System can be used as a static fixator or dynamically applying distraction or compression to the small bones of finger and toe. The system provides treatment for small bone fractures, including severe open finger and toe fractures, highly comminuted close fractures, monunion and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, figure and toe deformity corrections, burn maintenance, and bone grafting defects and fusion of a joint.

Normed Mini External Fixator System is a unilateral (uni-bar) external fixation frame consists of a series of clamps, rods and half pins. The frame is consists of Adjustable Polyetheretherketon (PEEK) Swivel Clamps, PEEK Simple Swivel Clamps, Stainless Steel Distraction/Compression Rods, PEEK Carbon Fiber Smooth Connecting Rods and Stainless Steel Half Pins. The 4mm rods are designed to provide a connecting element for the clamps and are available in 25,40,50 and 80 mm length. The clamps are manufactured from Polyetheretherketon (PEEK) in one size. The adjustable swivel clamp will be used with stainless steel distraction/compression rods for dynamically applying distraction or compression to the small bones of finger and toe. The simple swivel clamp will be used with Polyetheretherketon PEEK carbon fiber stabilizer rods for static fixator.

The provided text is a 510(k) summary for the Normed Mini External Fixator System. It details the device's components and indications for use, but it does not contain any information about acceptance criteria, study designs, sample sizes, expert involvement, or any performance data comparable to what would be found in a clinical or statistical evaluation.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for test sets.
• Number/qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details.
• Standalone performance study details.
• Type of ground truth used.
• Training set sample size or ground truth establishment.

The document focuses solely on the device description and its substantial equivalence determination based on its intended use and similarity to legally marketed predicate devices, as per the 510(k) pathway. It's a regulatory submission, not a scientific study report.

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