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Flex Arm Retractor System intended to provide surgeons with instruments such as retractors, dilators, probes, protecting shield to perform a variety of neurological procedures utilizing MR visualization. The device may be used in surgical procedures requiring dissection and retraction of tissue. It is intended to be used by trained medical professional in operating room environment.

Flex Arm Retractor System intended to provide surgeons with instruments such as retractors, dilators, probes, protecting shield

I am sorry, but based on the provided document, I cannot extract the acceptance criteria and the study details as requested. This document is a 510(k) premarket notification letter from the FDA regarding the "Flex Arm Retractor System." It primarily confirms the substantial equivalence of the device to a legally marketed predicate device and outlines regulatory compliance.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about a specific study, including sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
• Information on how ground truth was established for training or test sets.

Essentially, this document is an administrative approval letter and does not delve into the technical study details that would typically support such an approval.

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