Verification & Validation

Presentation
“Soni-Guide”
Frank Zhang, Suchith De Silva, Kevin Spehar
Mar. 3rd, 2019
Overview

● Updates from Progress Report

● Verification Testing Plan
● Validation Testing Plan
● FDA Process of “Soni-Guide”
● Proof-of-Concept Testing
● Overall Status
Solution Overview
● Ultrasound sensor will detect
nearby objects

● Vibrational motors will pulse

along the wrist to indicate
location and proximity of the
object to the user

● Infrared sensor will determine

whether or not the detected
object is human or not
○ If human, a unique
vibration pattern will
inform the user that the
detected object is human

● Solution will be implemented

through Arduino
Updates from Progress Report
Parameter Specifications

Range 0-3 m in front of the user

Vertical Detection 15 cm above the user’s head

Operational Verifiable Range: 0 - 40℃

Temperature Theoretical Range: -10 - 60°C

Feedback Frequency 2 Hz

Sensing Frequency 10 Hz

Minimum Size 3 cm width

Detection

False Positive Rate < 2%

(Type I)

False Negative Rate < 1%

(Type II)

Human Differentiation 1m
Range
Changes of Design Schedule
Verification Plan
● Range

● Vertical Detection

● Feedback Frequency

● Sensing Frequency

● Minimum size detection

● Detection Accuracy
Verification Plan -- Detection Range
(Completed)

At distances of 0.4m, 0.8m, 1.2m, 1.6m, 2.0m, 2.4m, 2.8m, 3.2m,

3.6m, and 4.0m, objects and people were placed away from the

device to determine whether they were detected. Infrared sensor

will be test under similar method, but shorter range.

Verification Plan -- Feedback Frequency
(Completed)

Verify that the device is able to deliver more than 2 vibration

patterns per second, so that the user will be updated on the

position of nearby objects at least twice every second.

 Ultrasound
Sensor

Vibrational
Motor
Verification Plan -- Sensing Frequency
(Completed)

Ensure that the device sensors are able to output distance and

temperature at least 10 times per second to be able to filter out noise.

Verification Plan -- Minimum size detection:
Using LEGO pieces, differently sized structures of varying widths will be

constructed and placed 1m away from the device. At best, the device

should be able to detect a LEGO structure of 3cm width. (Mainly for

ultrasound sensor)
Verification Plan -- Detection Accuracy:

Multiple objects will be placed in an arc about 1m away from the device.

The device will be turned to face different objects at different marked

positions. The device should be able to detect the presence of these

various objects at a rate of 98% accuracy.

Validation Testing Plan
● Randomly selected students with normal vision will be blindfolded
and instructed to use the device over a period of 30 minutes to
understand how to interpret the vibrational feedback.

● Following instruction, the subject will be equipped with the device and
asked to complete a designed course with different categories of
obstacles (including overhanging objects, hot objects, and humans).
Validation Plan -- Continued

After the subject has finished the course, their performance will be

assessed in terms of how many obstacles were navigated around

successfully (In terms of corresponding obstacle category).

 Subject Survey
How comfortable was the device for Wearability?
you in terms of... (1-5)
Vibrations?
How easy was it for you to become
familiarized with using the device?
(1-5)
How useful was the device for
detecting objects in a timely
manner? (1-5)
How much do you estimate the
device would interfere with your
daily life? (1-5)
Do you have any other
comments/suggestions?
FDA Process
The device closely lines up with the FDA definition of an electronic vision
aid. It is also medically acceptable (510k form)

Stated in the Code of Federal Regulations for ophthalmic devices in

section 886.59

Such devices are categorized as Class I medical devices.

Proof of Concept Testing

Placing a person at varying distances away from

the device, in increments of 0.4m starting from 0m
up to 4m.
10 trials were conducted at each distance to
ensure that the device could detect and output the
correct distance of the person.
Testing Result Sample Size: 10 seconds,
20 outputs per seconds

Mode of the data for each data

was taken as the result of each
trial.

10 trials test were executed at

every distance.

Hits: 9 or above

Parital: 6 - 9

Miss: 5 or below
Overall Status of the Project
Legends:
Ultrasound Sensor
Ultrasound Sensor

Infrared Sensor

Infrared Sensor

Vibrational Motor
Simplified Vibration Motor Feedback Response to Various Ultrasonic
Detection
Ultrasound sensor detection Vibration motor feedback

Only A 1 and 2

Only B 3

Only C 4 and 5

A and B 2 and 3

B and C 3 and 4

A, B, and C (convergent on 3
one object)

A, B, and C (divergent to 1, 2, 4, and 5

multiple objects)
Simplified Vibration Motor Feedback Response to Infrared Detection

Infrared sensor Vibration motor

detection feedback

Human Object Sequential

Vibration

Hot Object Higher intensity

pulse
Q & A?

Thank You