Table 1

Evaluations completed on the product

1. Hydrostatic pressure testing for barrier performanceBarrier performance evaluation for all critical zones within metal and linen components of product, using pressurised testing with simulated blood
2. Biological evaluationCytotoxicity testing, chemical composition of constituent materials, effects of manufacturing processes, effects of interaction between materials and contact with patient, material degradation and leachable substances
3. Usability and human factors evaluationFormal usability and human factors evaluation completed with nurses and surgeons to ensure ease of use while maintaining sterility, as well as validation of labelling and training materials
4. Lifetime testingExtensive lifetime and durability testing in high-fidelity simulated use environments to ensure linens and other components withstand the demands of in-field use
5. Electrical evaluationThird-party lab evaluations with QAI Labs to show electromagnetic compatibility, electromagnetic interference and leakage in line with requirements for medical devices
6. Drill in-field use and warranty dataAnalysis of warranty claims from Bosch and DeWalt over hundreds of thousands of drill devices in the field confirm electrical risk analysis results and safety
7. Drill performance studiesEvaluations to ensure appropriate drill speed, torque, pull-out strength and overheating performance
8. Bone drilling performance studyEvaluation of surgical drill and Arbutus Drill Cover System drilling into bone models by surgeons showed no statistically significant difference in hole size, accuracy, usability or time
9. Steam sterilisation and cleaning validationExternal lab testing with Nelson Laboratories to confirm and validate effectiveness of steam sterilisation protocol and instructions
10. Clinical studyClinical evaluation focused on usability showed preference over manual hand drills across 95 orthopaedic cases, showing a 30 min reduction time per case over manual drills
11. Packaging performance evaluationVerifies packaging performance for safety of shipping and storage
12. ISO 13485 certified quality management systemAll Arbutus products are designed, manufactured, stored and marketed under a carefully controlled ISO 13485 QMS as certified by the British Standards Institution (BSI)
13. Comprehensive ISO 14971 risk management fileArbutus Medical follows a rigorous ISO 14971 Risk Management process for ensuring safety and efficacy of all products