| Requirement | Verification | Validation |
| 1. Range of Motion | The device’s accuracy will be checked by comparing its readings to a fixture with known angles (10°, 60°, 90°, 110°, 135°). Any discrepancies will be corrected to ensure accuracy. | Human testing will be performed. Users will use the device at 10-degree increments and confirm if full ROM is achieved. |
| 2. Assistive | A) Test device force output from 5 to 60 N using a force gauge, ensuring ±5% tolerance. B) Measure bending moments with applied forces, confirming they stay within 4 N·m ± 1 N·m in the sagittal plane using a torque sensor. | Human testing will be conducted for a variety of subjects. The device exerted sufficient force to move the leg in a continuous motion. |
| 3. Heating component | Use a non-contact thermometer to measure the temperature, setting the range between 38-41°C. | Test the device on a number of subjects. The subject was able to feel the desired temperature |
| 4. Heating Time | A) Check temperature of the device to see if it can reach the temperatures of 41°C within 5 minutes. B) Check temperature every two minutes to see if temperature can be maintained up to 30 minutes. | A) The subject was satisfied with the desired temperature being reached in a timely maner. B) The device maintained therapeutic temperature for a desired amount of time. |
| 5. Temperature measurement | Monitor the temperature every 10 seconds for 30 minutes, applying controlled temperature changes. Ensure the device can detect variations within ±0.5°C to confirm its accuracy. | Same as verification |
| 6. Data tracking | Compare the repetitions, duration, ROM and temperature tracked by hand to the collected data of the device to confirm accuracy. | Same as verification |
| 7. Data storage | A set of data points and parameters will be stored and be able to be accessed. | Same as verification |
| 8. Transmit data | Conduct a data transmission tests under typical usage conditions by using a network analysis tool to measure the transmission rate and confirm it meets or exceeds 1 Mbps. | Same as verification |
| 9. User input | Patients and medical professionals will input their desired parameters and the device will be tested to ensure it adjusts its operation. | The user input interface was user-friendly. |
| 10. Adjustability | Conduct fit testing with participants of varying thigh, knee, and calf sizes, adjusting straps for a secure fit. Measure before and after adjustments to confirm specifications and comfort assessments. | The subject was satisfied at how securely the device was on the leg. |
| 11. Fail safety | Heat the device above 43 °C, recording the temperature every minute to check for automatic shutdown. | Same as verification |
| 12. Manual Shutoff | Ensure device shuts off when the button is pressed confirming responsiveness. | Same as verification |
| 13. Electrical Safety | Use resistor and capacitor to mimic the impedance of the human body. Use two probes to test different parts of the device to see the current to ensure that it is below 100 µA. | Same as verification |
