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The Fixano TWIN FIX wrist fixation device is intended for use in upper extremity applications for the reduction, alignment and stabilization of intraarticular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.

The device is a radiolucent external fixator capable of limited range of motion.

The provided FDA filing (K022771) for the Fixano TWIN FIX device does not contain information regarding the acceptance criteria, reported device performance, or any studies proving the device meets acceptance criteria.

The filing is a 510(k) Premarket Notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with specific performance metrics.

Therefore, I cannot populate the requested tables and information. The document focuses on:

• Device identification: Manufacturer, classification, names, etc.
• Substantial equivalence: Comparing the TWIN FIX to existing devices like the Danek Wrist Fixator.
• Intended Use: Stating the purpose of the device (reduction, alignment, and stabilization of fractures and deformities in the upper extremity).
• Regulatory communication: The FDA's letter confirming substantial equivalence and allowing marketing.

There is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set or its provenance.
• The number or qualifications of experts.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size or how ground truth was established for it.

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