(75 days)
EBA2 Femoral Nailing System is intended for insertion into the medullary canal of femur for the alignment, stabilization and fixation of various types of fractures or deformities caused by trauma or disease. These include: tractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.
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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets such criteria. The document is a letter from the FDA to Citieffe S.r.l. regarding the 510(k) premarket notification for the EBA2 Femoral Nailing System. It primarily discusses the substantial equivalence determination and regulatory requirements for marketing the device.
The letter does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance for test or training sets.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- How ground truth for the training set was established.
Therefore, I cannot fulfill your request for this specific information using the provided document.
§ 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.