ENOS Software Guided External Fixation System

The ENOS Software Guided External Fixation System is a cloud-based medical software application that assists orthopedic surgeons in planning patient-specific deformity corrections for use with the Paragon 28 Monkey Rings Circular External Fixation System. Surgeons input anatomical alignment values, hardware configuration parameters, and treatment objectives; the software then generates a patient-specific prescription of strut adjustments for treatment of traumatic or reconstructive bone deformities.

The subject device is a web-based software run in the cloud, whereas the secondary predicate (Orthohub) uses a Macintosh computer. The subject device relies on manual surgeon input only, while the secondary predicate uses x-rays in addition to manual input. Both the subject and primary predicate devices have manual input methods and allow visualization of moving bone position, computing strut lengths necessary for the surgeon's adjustments.

Software verification and validation were performed based on the FDA 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' at unit, integration, and system levels. Non-clinical bench testing included incremental testing of software inputs against expected frame data using mathematically randomized input sets over defined limits.

The subject device has similar intended uses, technological characteristics, and principles of operation as the primary predicate (SixFix Hexapod Fixator and DACS) and secondary predicate (Orthohub External Fixator Software). Both generate a prescription of strut adjustments and allow surgeon visualization of bone position. Differences such as cloud-based versus local deployment and manual-only versus manual-plus-x-ray inputs do not introduce new safety or effectiveness issues, making the device substantially equivalent to legally marketed predicates.