The knee brace device can be evaluated through targeted tests and criteria assessing its functionality, durability, and safety. Each test aligns with specific performance parameters essential for determining whether the device meets the required standards for proper implementation.

1. Structural Integrity Assessment

• Purpose: To ensure the knee brace can withstand everyday stresses, such as those experienced during walking, bending, and general knee movement, without risk of failure.
• Evaluation Criteria:
  • Von Mises Stress: This test will measure the maximum stress at critical points to confirm it remains within the safe limits of the material’s yield strength. Ensuring stress levels below this threshold is essential to prevent material failure under load.
  • Reaction Forces: Reaction forces across all axes (X, Y, Z) can be measured at fixed points to verify stability and resistance to movement.

2. Load-Bearing Capacity

• Purpose: To verify the knee brace can support the loads applied during normal and extreme knee movements without excessive deformation.
• Evaluation Criteria:
  • Displacement: The device should demonstrate minimal displacement under load to maintain structural stability. By evaluating displacement, one can ensure the brace’s parts hold their positions effectively without sagging or bending.
  • Equivalent Strain: Equivalent strain levels should indicate that the material can handle stretching and bending without permanent deformation. Strain limits help determine whether the device will maintain shape after daily wear.

3. Material Verification

• Purpose: To confirm that the knee brace’s material properties match specifications, ensuring it can handle expected stresses and perform reliably over time.
• Evaluation Criteria:
  • Yield Strength and Elastic Modulus: Tests will validate that the material’s strength and elasticity meet the designated values, supporting load endurance and user comfort flexibility.

4. Mesh Quality and Accuracy Verification (for Simulation Fidelity)

• Purpose: To confirm that the model’s mesh quality supports accurate simulation results by avoiding distortion and optimizing element sizing for critical areas.
• Evaluation Criteria:
  • Aspect Ratio and Element Distribution: A well-constructed mesh with a balanced aspect ratio (preferably less than 3) helps ensure accurate simulations, reflecting real-world stress and strain distributions.
  • Distortion Levels: Minimizing element distortion is essential for obtaining valid data, as distorted elements can lead to inaccurate stress concentrations and strain results.

The knee brace’s ability to perform reliably and safely under real-world conditions can be assessed by conducting these evaluations. Meeting these criteria will confirm the device’s readiness for practical implementation, providing confidence in its performance and durability.