TraumaCad Neo (1.1)

TraumaCad Neo 1.1 is a software system that assists orthopedic surgeons in pre- and post-operative planning by overlaying measurements and prosthesis templates onto radiological images. The software enables surgeons to analyze orthopedic conditions, plan procedures, and review outcomes on screen, supporting a film-less orthopedic practice across multiple anatomic regions including hip, knee, foot, ankle, and upper limb.

The submitted device adds support for PACS and EMR system integration alongside Quentry cloud connectivity (versus predicate supporting only Quentry), expands OS support to iOS 17.x, MAC Sequoia, and Android 14, and introduces automatic AI/ML-based landmark detection for post-operative hip arthroplasty analysis. All other core features including template libraries, interactive positioning, multiple surgical modules, and device platforms remain functionally equivalent to the predicate.

Not stated in this summary.

TraumaCad Neo 1.1 maintains identical indications for use and fundamental intended purpose as the predicate device TraumaCad Neo 1.0. The new integration capabilities (PACS/EMR) and local software delivery option are non-invasive additions that enhance workflow without changing the core analysis function. The AI/ML automatic landmark detection for hip images performs at 99% implant detection accuracy and 92% landmark detection accuracy within 4mm acceptance criteria, meeting pre-specified performance thresholds and demonstrating the new feature does not introduce additional safety or efficacy concerns. All modifications represent enhancements to existing capabilities rather than changes to fundamental operating principles.