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510(k) Data Aggregation
(45 days)
The Block Stop Wires device is intended for use in the osteosyntheses of epiphysial fractures with small osteoarticular fragments and for temporary support of dislocations of small articulations.
The Block Stop Wires device is an internal wire fixation device to be used on various types of articular fractures.
I apologize, but the provided text from the document "K964087" is a 510(k) summary for a medical device called "Block Stop Wires." It describes the classification, substantial equivalence, device description, intended use, and technological characteristics of the device.
However, the document does not contain any information regarding acceptance criteria, device performance study results, sample sizes, expert qualifications, ground truth, or adjudication methods. Therefore, I cannot generate the requested table or answer your specific questions based on the input provided.
To answer your questions, I would need a document that details the device's validation studies and performance evaluation.
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