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Indicated for open and closed long bone fracture fixation to include tensioned wire fixation of periarticular fractures, arthrodesis, limb lengthening, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities.

This submission covers DePuy Orthopaedics' external fixators and their performance in the MR environment. The ACE-Fischer system is classified as MR Unsafe.

The provided text is a 510(k) premarket notification for the ACE-Fischer® External Fixation System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

Instead, the submission focuses on demonstrating substantial equivalence to currently marketed versions of the device, stating:

• "The technological characteristics of the devices that are the subject of this submission remain unchanged from the predicate in design, material and performance."
• "Evaluation was done based on ASTM F2052 to determine MR compatibility." (This refers to a standard for assessing MRI compatibility, not a study to prove performance against specific clinical acceptance criteria).
• The system is classified as "MR Unsafe."

Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, or details about a comparative effectiveness study, ground truth, or training sets, as such information is not present in the provided document. The document's purpose is to establish substantial equivalence for regulatory clearance, not to detail a clinical performance study against specific acceptance criteria.

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