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Intramedullary nails are anatomic implants specially developed for osteosynthesis. Their objective is to stabilize and fix a fracture through intramedullary blocking. The "Baumer Locking Nail" is indicated to intramedullary fixation for fractures of the tibia (Tibial Locking Nail) and femur (Femoral Locking Nail). The device is for single use; it's should never be reused.

Intramedullary nails are anatomic implants specially developed for osteosynthesis.

I am sorry, but the provided text does not contain the detailed information required to answer your request about the acceptance criteria, study details, and performance of the Baumer Locking Nail.

The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device. It specifies the regulation numbers, product codes, and indications for use.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test or training sets.
• Information on data provenance (country, retrospective/prospective).
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes of AI assistance.
• Details of a standalone algorithm performance study.
• The type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for the training set (if applicable) was established.

This type of information is typically found in the 510(k) submission itself, or in supporting documentation for clinical studies, which is not part of this FDA clearance letter.

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