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This device is indicated for use in the fixation of subtrochanteric fractures.

The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Sub-Trochanterian Fractures is an implantable device be used in orthopedic trauma to procedures.

This appears to be a 510(k) premarket notification for a medical device called the "Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Sub-Trochanterian Fractures." This documentation focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study to prove acceptance criteria based on detailed performance metrics.

Therefore, the provided text does not contain the information requested to describe acceptance criteria and a study that proves the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details about a specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information on MRMC studies or standalone algorithm performance.
• Information on training set sample size or how its ground truth was established.

This document is a regulatory submission demonstrating substantial equivalence, not a clinical or performance study report.

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