(119 days)
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.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.