Obi Medical Robot: Evaluating Effectiveness Related to Usability in Providers, Caregivers & Patients
Conditions: Upper Extremity Impairments, Cerebral Palsy (CP), ALS - Amyotrophic Lateral Sclerosis, Rett Syndrome
Sponsor: Desin LLC

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Jon Dekar
jdekar@desincorp.com
7018 A C Skinner Pkwy Ste 270, Jacksonville, Florida, 32256 
Confidential information contained herein is made available to you in your 
capacity as Investigators, Medical Advisor, or 
provided only for review by you, your staff, Institutional Review Boards or other 
regulatory authority. Except as necessary to obtain properly Informed Consent 
for participation, it is expected there will be no disclosure to other third parties.
Clinical Investigation Plan (CIP)
Obi Medical Robot: Evaluating Effectiveness 
Related to Usability.

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Review and Sign-Off
The document is effective following the final date of approval. 
Approved by
Signature
Date of Approval
Jon Dekar
President & CEO
(Sponsor & Site)
Dr. Andrea D.Fairman, PhD, 
Doctor: ADRS 
Heather Keeton, ATP
Research Coordinator
 
Dr. Ryan Osal
 
Research Assistant
 
 

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Table of Contents
Table of Contents ...............................................................................................................................................3
A. 
Clinical Investigation Plan ....................................................................................................................... 4
A.1.
General ..............................................................................................................................................4
A.2. 
Identification and description of the Investigational Device ................................................................ 10
A.3.
Justification for the design of the clinical investigation........................................................................ 19
A.4. 
Benefits and Risks of the Investigational Device and Clinical Investigation .......................................... 20
A.5.
Objectives and hypotheses of the clinical investigation ...................................................................... 22
A.6. 
Design of Clinical Investigation .......................................................................................................... 24
A.7. 
Statistical Design and Analysis .......................................................................................................... 43
A.8. 
Data Management ............................................................................................................................. 51
A.9. 
Amendments to the CIP..................................................................................................................... 54
A.10.
Deviations from the CIP ................................................................................................................. 54
A.11.
Device Accountability .................................................................................................................... 57
A.12.
Statements of Compliance ............................................................................................................ 57
A.13.
Informed Consent Process ............................................................................................................ 60
A.14.
Adverse events, adverse device effects, and device deficiencies..................................................... 60
A.15.
Vulnerable Population (if applicable) ............................................................................................. 64
A.16.
Suspension or premature termination of the Clinical Investigation .................................................. 65
A.17.
Publication Policy.......................................................................................................................... 66
A.18.
Bibliography .................................................................................................................................. 67
 ........................................................................................... 68
Appendix B: Other Supporting Documentation ............................................................................................... 69

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A. Clinical Investigation Plan
This CIP was composed with guidance from ISO14155:2020, Annex A.
A.1. 
General  
A.1.1. Introduction
First commercialized in 2016, the Obi medical robot represents an innovative approach to self-feeding 
restoration, enabling patients with upper extremity mobility (UE) limitations to feed themselves. Obi is a 
Class I, 510K Exempt medical device (product Co
risk” device. To date, over 3,000 devices have been sold across 20 countries without an adverse event. 
Minor enhancements and features have recently been developed to support increased usability with Obi: 
The Generation3 (Obi3) project (ECR#172). This project has recently completed successful Design 
Verification activities, including successful verification of risk control measures, and has been approved 
for the Design Validation stage in a design review (IFD-DES-
Prior to commercialization, it is both an FDA regulatory requirement and ISO13485 QMS obligation to 
validate whether the enhanced design continues to fulfill its intended use and meet the user needs of key 
stakeholders (as defined in IFD-DES-025 R5.6.0). In addition to these primary objectives, other aspects 
of usability and stakeholder experience will be explored as secondary objectives.
A.1.2. Identification of the Clinical Investigation Plan 
Revision
Summary of Changes
1.0.0
Initial release. 
Associated Study Documentation 
ICF - Provider 
ICF- Patient (Adult) 
IAF -Patient (Child)
Survey - Patient (Adult)
Survey - Patient (Child)
Survey - Caregiver
Survey - Provider
Semi Structured Interview - Patient (Adult)
Semi Structured Interview - Patient (Child)
Semi Structured Interview - Caregiver 
Semi Structured Interview - Provider
Recruitment Flyer, Obi 
CRF, Protocol Deviation 
PI CV, Dr. Fairman 

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A.1.3. Sponsor
 
Address
7018 A C Skinner Pkwy Ste 270, Jacksonville, Florida, 32256
FDA Registration#
3012103590
www.meetobi.com/
Phone
1-844-435-7624
Emails
info@meetobi.com, service@meetobi.com
A.1.4. Principal Investigator; Coordinating Investigators and Site(s)
Name
Address
Email/Phone #
Principal Investigator (PI):
Andrea D. Fairman, Ph.D., 
P.O. Box 978
716 Black Hut Road
 
-
-4588
Research Assistant: 
CHC, CEAS
Ryan will work remotely as an 
company.  He presently 
 
-5584
Research Coordinator: 
Heather Keeton, ATP
 
 
-
Study Site & Sponsor
Jon Dekar
President & CEO
  
See A.1.3.
 
-

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Team Member
Qualifications
Jon Dekar
Sponsor
and quality practices.  He has pro
Dr. Andrea 
Fairman
Principal 
-
-suited to lead this research 
ce-based practice, and 
-
impact on functional independence. Her prior research demonstrates experience in 
-
 
-
-
pediatric rehabilitation, and psychosocial impact measurement, Dr. Fairman is well-
 
(see curriculum vitae for additional information)
Heather Keeton 
Co-
Research 
Coordinator
-
She also carries a CITI
an expert on how Obi is used in the field. 
Dr. Ryan Osal
Co-
Research 
Assistant
tools with clinicians and older adults. As a licensed occupational therapist with clinical 
-
interdisciplinary collaboration. 
(see curriculum vitae for additional information)

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A.1.5. Overall Synopsis of Clinical Investigation
Protocol Synopsis
Study Title
- Version
-DES-
-
-
stakeholder needs 
and intended use as defined 
-
DES-
 
 
 
o Determine patient usability in accordance with the 
Framework and assessment (adult and pediatric 
 
o 
o 
 
o 
efficiency, and satisfaction of the Obi clinical assessment 
 
o 
 
This is a mixed-
 
• Participants will complete a one-week trial of Obi 3. 
non-
-
or two members of the triad wish to participate, they will still be 
Study Population
 
 
Estimated # of Sites
features, is included later in this proposal. 

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Enrollment and Subject 
Participation Duration
- 3 month period.  
Participation in the study is approximately one week in duration 
follow-up semi-
conducted with all the participants.  Follow-
conducted
whose responses require clarification or warrant further inquiry.
Endpoint
Assessment of user needs fulfillment after ~ one (1) week trial of 
 
I.) Providers will complete - 
their needs are fulfilled with the usability of Obi Gen3. 
 
II.) Caregivers will complete -
whether their needs are fulfilled with the Obi Gen3. 
 
III.) Patients will complete:
whether their needs are fulfilled with Obi Gen3.
Primary Safety Endpoint
 
; one are anticipated  due to the 
 
Additional Endpoints
a. 
b. 
 
 per 
 
c. Optional - Semi-
 
a. 
b.
assessment.

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trial period.
c. Optional - Semi-
 
 Patients 
a. 
assessment.  
trial period.
b. 
-participants 
Form. 
c. Optional - Semi-
 
 
- 
- 
 
- 
Exclusion Criteria
- 
informed consent/assent
- 
-
-
-only materials) 
- Residents of California who are new Obi users
Study Procedure 
1) Pre-
subjects who would likely meet the criteria for participation in the 
study. 
mailed out with trial Obi Gen3 Medical Robot with triadic 
 
-
specific to the study procedure, it has been included here to help 
clarify the process.
 
5) ~ One (1) week home/community trial of Obi Gen 3 with a 

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electronic web-based link.   
8) Optional: Follow-
1) Pre-
 
-office assessment) 
 
 
8) Optional follow-
A.2. 
Identification and description of the Investigational Device
a) Summary Description of Investigational Device
Obi is a reusable robotic utensil intended to compensate for the function of a human arm during 
-feeding) status. Obi 
alleviates/ameliorates the disability caused by medical diseases/conditions that completely or severely 
impair the upper extremities/limbs. 
The user interface accommodates mobility on most body areas through connections compatible with 
many different types of off-the-shelf Accessibility Switches. Further, the arm can adjust within a large 
volume of space, thus accommodating individual ergonomic needs pertaining to the chosen food 
perpetually store this position, thus eliminating the need for re-currant setup and minimizing caregiver 
involvement. 
By fulfilling its intended use, Obi has the potential to improve quality of life and alleviate/ameliorate or 
prevent medical issues known to be associated with lack of self-feeding, including, but not limited to, 
gastroesophageal reflux disease (GERD), aspiration, aspiration pneumonia, malnutrition, dehydration, 
and psychological and/or social health impairment. 

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Obi, a Robotic Medical Device for Self-Feeding.

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FDA Device Classification: Obi is an FDA-compliant Class I, 510k exempt medical device. It is 
Assist Device,  Eating. The device listing number is as follows: 
For more information, including justification for device classification, please refer to IFD-DES-001, US 
Regulatory Plan. 
About Obi3 (Gen3): 
focused strongly on design for manufacturability, quality, and reliability-related improvements (see 
ECR#077). In response to feedback from the marketplace, G
changes and more on minor but significant usability improvements. 
Perhaps most notably, some patients have experienced dissatisfaction with limited spoon sizes and the 
spoon detaching from the device too easily. For example, some patients living with Cerebral Palsy, 
Spastic Quadriplegia, that are otherwise strong candidates for the device, may struggle to keep the 
spoon attached to the arm during use. Additionally, pain points are communicated related to the inability 
to differentiate between the actions of the two provided black pressure switches and a lackluster 
packaging experience that does not harmonize with the device's quality or aesthetics.  
The following table lists the significant changes in scope with Obi3:

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b) Details concerning the manufacturer of the investigational device 
Improvement
Description
Utensils (see IFU for photos)
Four (4) new utensils were designed. Changes include a wider 
variety of spoon-bowl shapes (a smaller spoon, a larger spoon, a 
spork, and a classic spoon). The resin material was also changed 
to a more durable food contact resin with better dishwasher 
properties. The attachment cup geometry was also modified for 
proper mating with the revised Utensil Adapter  
Utensil Adapter
A new attachment point was installed on the end of the Obi arm to 
correct the spoon's tendency to separate inappropriately under a 
specific direction of applied force. 
Software Features
can activate a pressure switch for 1.5 seconds to power on the 
device.  
Reward Mode: Using a special code combination, the device will 
move through special motions for approximately 1 minute to 
encourage or reward favorable self-feeding behavior. 
In Bowl Collision Backup: In response to an in-bowl collision with 
large hard food particles, the device now slightly backs away 
following the food collision and re-scoops. 
Instructions For Use
Contraindications and Relative Contraindications sections. 
pertaining to the revised Obi3 features: new utensils, patient 
power on, and reward mode. Further specification of Cleaning and 
Disinfection Instructions. 
Quick Start Guide 
Revised imagery related to the Food Preparation Section to 
promote better understanding of food preparation needs for 
optimal food capture efficiency.  
Color change to the provided 
accessibility switches
in black and 1 in white to promote improved differentiation. 
 
A QR code is now applied to the Base to promote convenient 
access to support materials such as an electronic IFU, Quick Start 
Guide or other instructional videos.
Packing Box
The packing box imagery was updated with a high resolution digital 
print and a QR code print for easy access to support materials. 

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witnessed his grandfather lose the ability to eat independently due to a degenerative 
neuromuscular disease.  
quality management systems (QMS), ISO13485:2016 by Eagle Registrations Inc., an accredited 
quality system includes the design, manufacturing, distribution, and servicing of general medical 
F2P22725A-05S). 
c) Name/Number and Model/type, including software version and accessories
Devices under test with this study will occur with Obi3 production candidate devices utilizing 
production-intended materials and processes.  
Obi3, US
Model#
IFD-500-031
Obi3 will ship to participants with the following content: 
Component
Quantity
Obi3 Device
1
Pressure Switches
2
Utensils (2 copies of each)
8
Plate
1
Placemat
1
AC Adapter
1
Instructions for Use
1
Quick Start Guide
1
The following is an image of what will arrive with each device inside the box: 

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The following is a list of the significant Obi3 production candidate components that will be assembled to 
 
Part#
Rev
Obi Control Board Software 
Rev
IFD-700-003
7.2.0
Utensil Adapter, Obi3
IFD-400-110
1.0.0
Small Spoon
IFD-400-102
1.1.1
Classic Spoon
IFD-400-100
1.1.1
Spork
IFD-400-108
1.1.1
 
IFD-400-101
1.1.1
Obi Instructions for Use
IFD-600-003
5.1.0
Quick Start Guide
IFD-600-002
2.0.0
The following is an image of the aforementioned Obi3 spoons and spork:

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d) Description as to how traceability shall be achieved during and after the clinical 
investigation (lot/batch/serial numbers)
production and process controls. Each device constructed will include a documented device 
history record (See IFD-801-012, Obi Travel Router (DHR)). These DHRs will consist of the Obi 
serial number, lot number, and component traceability information (rev, serial#, lot#) for all 
critical components, including the Obi3-specific components listed above. Each record will also 
include the date of manufacture, the person responsible for building and completing each 
subassembly, and the inspector's name, which is the quality check for each sub-assembly.
Each device will also include the following labeling affixed to the underside of the devices:
e) Intended Use
Per IFD-600-
1. Obi alleviates/ameliorates 
the disability caused by medical diseases/conditions that completely or severely impair the upper 
extremities.” 
1  

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f)
Indications for Use/Intended Purpose
Per IFD-600-
healthcare professional) living with congenital or acquired neurological, neuromuscular, or 
musculoskeletal impairment of the upper extremities affecting the ability to independently perform and 
participate in mealtime activities for daily living. Obi users may have the following medical 
diseases/conditions: 
 Amputees 
 
 
 Arthrogryposis Multiplex Congenital (AMC) 
 Cerebral Palsy 
 
 
 Developmental Disabilities 
 Essential Tremor 
 Multiple Sclerosis 
 Muscular Dystrophy 
 
Disease 
 Spinal Cord Injury 
 Other conditions impairing motor control of the upper extremities.  
In addition, patients must have the cognitive ability to understand cause and effect (i.e., active a switch 
to perform a function).” 
Absolute Contraindications:  
Per IFD-600-
the device must not be used because the risk of use outweighs any possible benefit. However, several 
conditions may carry risk and therefore, caution should be considered via a benefit/risk assessment with 
Relative Contraindications/Precautions
Per IFD-600-
severity that results in an unacceptable compromise to the benefit/risk ratio provided by the device. 
n to whether the following attributes pose an 
unacceptable risk to unsafe feeding or eating.
A. Cognitive/behavioral impairment: Inability to understand or correctly use the device and/or at 
risk for combative/self-injurious behavior during meals. 
B. Deviations from pre-
made to use Obi that would directly contradict any current recommended food or liquid 
textures/consistencies prescribed by a healthcare professional. 
C. Dysphagia: Significant oral motor, breath, or swallowing impairment that could pose an 
elevated risk of choking/aspiration (unless found appropriate by a treating healthcare 

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professional who has reviewed and discussed the benefit/risk assessment with the patient and 
/or caregiver). Any specific recommendations by the provider must be strictly followed.
D. Excessive movement: Uncontrollable/forceful movements that prevent the device's correct 
and/or safe use. 
E. Insufficient head control: Insufficient head control to position the Obi utensil reliably near the 
mouth. Or insufficient head and oral motor control to reliably remove content from the utensil. 
F. Insufficient movement: Unable to operate any compatible accessibility switches: Pressure 
Switch, Toggle Switch, Pillow Switch, Sip and Puff, etc. 
G. Reclined positions: Patients that cannot be positioned sufficiently upright for food/liquid 
consumption or maintain a sufficiently upright position throughout a meal (unless found to be 
appropriate by a treating healthcare professional). 
H. Open mouth sores: Any significant cuts, ulcerations, or oral bleeding. 
I. Open skin sores: Any open wound on an area of the body used to activate Accessibility 
Switch(es) or to contact Obi.” 
 
Side Effects: 
Per IFD-600-
 
g) Description of the investigational device, including any materials that will be in contact with 
tissues or body fluids.  
The utensils listed in section A.2.c will contact saliva and food. However, under normal or 
substances, human or animal tissues, derivatives, or other biologically active substances will be 
used.   
h) Summary of the necessary training and experience needed to use the investigational device 
based on risk assessment.  
The Obi Risk Management File does not identify any necessary training or experience as a risk control 
measure in order to use the device safely (see References section for a partial list of the 
ISO14971:2019 Risk Management File documentation). 
i) Description of specific medical or surgical procedures involved in the use of the 
investigational device.  
There are no medical or surgical procedures involved in the use of the investigational device. 
j) Reference to IB & IFU 
An Investigators Brochure was deemed unnecessary for this study due to its single site, the simplicity of 
the study, and its non-invasive nature. 
See A.2.b for IFU.  
 
 

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A.3.
Justification for the design of the clinical investigation
a)
an evaluation of the results of the relevant pre-clinical testing/assessment and prior clinical 
investigations, if applicable, carried out to justify the use of the investigational device in 
human subjects
A
Obi titled: The Use of Obi Robot for Self-Feeding with Individuals with Upper Extremity Limitations 
(pending publication with Assistive Technology Outcomes and Benefits Journal). 
The study consisted of the clinical observations and analysis of the author/independent examiner 
after assessing the performance data of individuals who used Obi for self-feeding. From the 
This descriptive study examined the functional performance of self-feeding in 19 
individuals with upper extremity limitations using Obi, a robotic self-feeding device. Participants 
ranged in age from 8 to 60 years and were observed across various environments, including 
homes, simulated-home setups, clinics, and schools. Participants ' performance with Obi was 
evaluated using observational methods and secondary data analysis. Results indicated that all 
participants successfully used Obi to feed themselves independently by activating switches 
connected to the device, with a 100% success rate in delivering food to their mouths by the 
final trial session. Different types of switches, customized according to the participants' needs, 
allowed for personalized feeding experiences and increased their social interactions with family 
and friends.  
accordance with its intended use, continue to meet user needs, and confirm a favorable 
benefit/risk ratio. 
b) An evaluation of clinical data that are relevant to the proposed clinical investigation.
A clinical evaluation has been conducted and documented within IFD-DES-021, Clinical 
Evaluation Plan (CEP) & Report (CER) pertaining to the Gen2 device in 2024. This document 
includes the results of a systematic literature review pertaining to powered feeding devices. The 
conclusion reads as follows: 
“Based on the successful review of all data included in this CER, it can be concluded that Obi is 
well documented in relation to safety and performance and suitable for use per its intended use. 
Consequently, there has not been identified any outstanding risks that will justify the enrollment of 
patients in a clinical study and as such, a clinical study is not necessary to demonstrate 
conformity with the requirements. A small number of non-safety related complaints and no 
product recalls related to the subject device were identified, and with an accumulated 
performance-related complaint ratio of 2% worldwide, this CER concludes that using Obi, which 
is a clas s I low risk medical device, is safe, compliant with state of the art, and that the risk level is 
acceptable when weighed against the benefits to the patient or even in comparison with the use of 
the similar devices. The overall benefit vs. risk ratio for Obi remains favorable. Based on 

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assessment of all available data in respect of Obi, it is considered that the subject device fully 
complies with the relevant GSPR in Annex I of the EU 2017/745 MDR.”
c) a description of the clinical development stage (see Annex I), if appropriate.
This study should be considered predominantly a post-market, non-interventional, observational 
study (Design Validation). 
Obi Gen 3 is a production equivalent Class I medical device intended to assist individuals with upper 
extremity motor impairments in self-feeding. This usability study is situated in the design validation stage 
of the product lifecycle, consistent with requirements outlined in ISO 13485 and FDA Quality System 
Regulation (QSR 21 CFR Part 820.30(f)) for medical device design controls. 
This investigation aims to validate that the design of Obi-Gen 3 meets the intended use and user needs 
as formally documented before broader commercialization. This study is not intended to evaluate safety 
or efficacy from a regulatory or therapeutic standpoint, as the device does not deliver treatment but 
facilitates an activity of daily living. Instead, it focuses on:
 Confirming that usability goals (e.g., efficiency, ease of use, satisfaction) are met,
 Gathering qualitative feedback from key user stakeholders (providers, caregivers, patients) and 
 Informing whether the design is ready for commercialization and on design enhancements, user 
support documentation, and deployment strategies.
This stage follows prior internal design and engineering iterations, including formative evaluations, and 
represents the first structured, multi-stakeholder usability assessment conducted with production 
equivalent units in real-world use. 
A.4. 
Benefits and Risks of the Investigational Device and Clinical Investigation
a) Anticipated Clinical Benefits
a. Device: Patients are anticipated to restore their ability to independently perform self-
feeding. Obi has the potential to improve quality of life and psychosocial health. Moreover, 
Obi may improve the caregiver-patient relationship, have a therapeutic impact, and have 
labor-saving/economic value.
b.
Clinical Investigation - Usability Study
Provider
Caregiver 
Patient

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b) Anticipated Adverse Device Effects
Device: There are no anticipated adverse device effects. The company has a history of no adverse 
events in 9 years and has sold over 3,000 devices. This is documented in the IFD-DES-021, 
Clinical Evaluation Plan & Report, which is current through 2024.
The results of this design validation study will inform an updated Risk Management Report 
-risk analysis, including the identification of any unforeseen 
potential use errors that require further risk assessment. 
c) Risks associated with participation in the clinical investigation
Physical risk: There is minimal physical risk in participating in the study. Obi is a Class I device 
with a history as a safe and reliable medical device if used according to its Instructions for Use 
(IFU). Since 2016, the device has never received notice of an adverse event. It carries a medical 
safety certification and listing compliant with the latest applicable medical device safety 
standards [e.g., IEC60601-1:2012, IEC60601-1-2:2020, IEC60601-1-6:2015, IEC60601-1-11:2015, 
etc.]. Obi is also designed, manufactured, and serviced within a certified medical device quality 
management system in accordance with ISO13485:2016.
The scope of user interface changes for Obi3 are minor adjustments, and do not represent a 
major conceptual departure whereby legacy post-market data may no longer be relevant. 
Modifications and new features undergoing development within Obi3 were evaluated with a safety 
risk assessment per SOP170, Safety Risk Management Procedures and ISO14971 a user interface 
formative evaluation (per IEC62366:2020) per IFD-DES-064 Formative Evaluation Plan, Obi3 (for 
results, see IFD-DES-070 Formative Evaluation Report, Obi3). These activities did not result in the 
identification of any new hazards, or potential use errors associated with the scope of Gen3 
changes (see IFD-DES-018, Product Hazards Analysis Table). However, updates to the Product 
Hazards Analysis were made to correct for previous oversights or unintentional errors. Summative 
evaluation was not performed as the user interface as it pertains to safety is considered 
unchanged (see IFD-DES-072, Summative Evaluation Plan).
Fatigue or Frustration: Participants may experience mild fatigue, confusion, or frustration during 
initial use of the device, particularly during the learning phase. These effects are expected to be 
temporary and self-limiting. Participants will receive onboarding materials and optional technical 
support to reduce this risk. 
Psychosocial Discomfort: Some participants may feel discouraged or self-conscious if they 
encounter difficulties using the device. The study includes an option to discontinue at any time 
and will collect feedback in a supportive, non-judgmental manner.
Data Privacy and Confidentiality: As the study collects identifiable information (e.g., 
stakeholder role, experience, and feedback), there is a theoretical risk of a breach of 
confidentiality or unauthorized data access. To mitigate this risk, all data will be collected via the 

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HIPAA-compliant Qualtrics platform, stored on secure servers, and accessed only by authorized 
study personnel.
d) Possible interactions with concomitant medical treatments as considered under the risk 
analysis.
ISO14971 related risk assessment has not identified any possible interactions with concomitant 
medical treatments (see IFD-DES-018, Product Hazards Analysis)
 
e) Steps that will be taken to control or mitigate risk. 
Risks identified within the Obi Risk Management File have previously been mitigated as far as 
possible without compromising the benefit-risk ratio (see IFD-DES-022, Risk Management Report). 
Additionally, Clinical Evaluation has shown a favorable benefit-risk ratio (see IFD-DES-021, Clinical 
Evaluation Plan & Report). Obi carries an active medical device safety certification to the current 
version of IEC60601-1 and applicable, related collateral standards. As previously mentioned, a risk 
assessment per SOP170 and ISO14971 was performed on the features of Obi3, and no new hazards 
associated with Obi3 were identified.    
patient is appropriately qualified for use with Obi before taking it home:
In addition to inclusion criteria, the pre-screen step of SOP220 conducted by on-staff providers prior 
to study/trial enrollment, will help to ensure only qualified candidates are being approved for use with 
the device and enrollment in the study. Additionally, the office assessment, conducted by the 
patient's benefit outweighs the risks of using the device. Only those Office Assessments where a 
favorable benefit-risk ratio is established will proceed to a home use 7-day trial.  
f)
Rationale for benefit-risk ratio. 
See IFD-DES-022 or IFD-DES-021 for further rationale of the benefit-risk ratio.  
A.5. 
Objectives and hypotheses of the clinical investigation 
a) The purpose of the clinical investigation, claims for clinical performance, effectiveness or 
safety of the investigational device that are to be verified 
This clinical investigation's purpose is to validate that the production equivalent Obi3 (including its 
labeling and packaging) conforms to its intended use and formally documented user needs, as required 
by medical device regulations and standards. The overall usability and user experience of the Obi3 
Medical Robotic Feeding Device will also be evaluated among key stakeholder groups, including 
providers, caregivers, and patients.  
This investigation does not seek to establish therapeutic or diagnostic effectiveness, as the device is not 
intended to treat or manage a clinical condition. Rather, it is intended to support independent self-

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feeding for individuals with upper extremity impairments—a key activity of daily living that contributes to 
personal dignity, autonomy, and quality of life.
The claims for clinical performance and effectiveness to be verified in this study include:
The device can be safely and effectively operated by the intended users (patients and caregivers) 
in a home, school, or community setting.
The device is recommended and integrated into practice by clinical professionals who support 
individuals with feeding-related disabilities.
The design features, controls, and user interface support efficient, effective, and satisfactory use.
The device enables users to independently complete a minimum of five meals during a one-week 
trial period without undue burden on caregivers or providers.
This clinical investigation also aims to verify that supporting materials (e.g., Quick Start Guide, 
expectations for performance, ease of use, and satisfaction. These claims will be evaluated through 
mixed-methods data collection, including surveys and semi-
being assessed in this study. Obi Gen 3 is a Class I medical device with minimal risk and has undergone 
benefit-risk analysis and mitigation per ISO 14971. However, participants will be monitored for device-
related issues or unanticipated problems during the trial. 
 
b) Objectives, primary and secondary, are described as ‘superiority,’ ‘non-inferiority,’ or 
‘equivalence,’ if applicable. 
 
PRIMARY: Validate whether the production equivalent enhanced Obi3 device design conforms to 
the formally defined user needs and intended use (per IFD-DES-054-1, Obi Validation Plan, Gen3) 
 
 
o Determine patient usability in accordance with the Matching Person & Technology Assistive 
Technology Framework. 
o Determine caregiver usability in accordance with questions from the Caregiver Burden 
Index. 
o Determine provider perspectives following the SUS as a standardized outcome measure.  
o Obtain provider feedback regarding the efficacy, efficiency, and satisfaction of the Obi 
clinical assessment forms and the associated process. 
o Obtain other qualitative feedback regarding the perceived strengths and weaknesses of the 
Obi design. 
c) Scientific justification and clinical relevance for effect sizes, non-inferiority margins, or 
equivalence limits, where applicable. 

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This clinical investigation is a formative design validation study intended to assess the usability 
and user experience of the Obi Gen 3 Medical Robotic Feeding Device. As such, the study is not 
designed to test predefined effect sizes, non-inferiority margins, or equivalence limits because it 
does not involve comparing clinical performance outcomes between devices or interventions.
d) Primary and secondary hypotheses, if applicable. 
This is not a hypothesis-driven study. This investigation aims to generate qualitative and 
quantitative data to determine whether the device fulfills its intended use and meets the 
functional and experiential needs of its users, including patients, caregivers, and providers. 
These data will guide product refinement, workflow integration, and stakeholder support 
strategies. Consequently, the scientific and clinical value lies not in statistical thresholds of 
performance superiority or equivalence but in identifying usability facilitators and barriers.  
Validated assessment tools used in the study (e.g., Matching Person & Technology 
Framework, System Usability Scale) provide benchmarks and interpretation guidelines (e.g., 
, which will be used for contextualizing findings. These 
interpretive thresholds will help determine whether observed results meet clinically 
hypotheses regarding effect size or non-inferiority do not apply to the design and objectives of 
this study, the clinical relevance is embedded in stakeholder feedback, validated usability 
scores, and evidence that the device enables functional independence as intended.
e) Risks and anticipated adverse device effects that are to be assessed.
The Obi Gen 3 Medical Robotic Feeding Device is classified as a Class I medical device under FDA 
and MDR regulations, indicating minimal risk to users. As such, no significant adverse device 
effects are anticipated in the context of this usability study.  
See section A4 for identified risks. 
A.6. 
Design of Clinical Investigation
A.6.1. General 
a) Description of the design type of clinical investigation to be performed (e.g., randomized, 
blinded or open-label, parallel groups or crossover, multicentre, international), the control 
group (e.g., comparative claim and reversible treatment of a chronic state), and the 
comparator with rationale and justification for the choice. Absence of control(s) shall be 
justified. 
This clinical investigation is designed as a non-randomized, open-label, single-group, single-site 
validation study. The study will employ a mixed-methods approach, incorporating quantitative and 
qualitative data to evaluate the usability, acceptability, and real-world applicability of the Obi Gen 3 
Medical Robotic Feeding Device.

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The study will not include a control or comparator group, as it is not intended to assess therapeutic or 
clinical effectiveness but rather to validate whether the device design fulfills user needs and intended 
use criteria. The absence of a control group is justified given the purpose and scope of the investigation, 
which aligns with medical device design validation under ISO 13485 and FDA QSR 21 CFR 820.30(f), 
rather than comparative clinical evaluation.
Participants—providers, caregivers, and patients—will be exposed to a single-arm intervention: a one-
week home, school, or community trial of the equivalent Obi-Gen 3 device. During this time, 
stakeholders will interact with the device in naturalistic settings to assess its usability, functional 
integration, and perceived value. 
The open-label nature of the study is appropriate given that: 
 The device is visibly distinct and cannot be blinded.
 The study seeks stakeholder feedback, including ease of use, satisfaction, and observed barriers 
or facilitators to use—all requiring unblinded interactions.
comparative claims or hypotheses are being tested, and no standard-of-care or alternate devices are 
being evaluated concurrently. The rationale for this approach is that the Obi Gen 3 is a Class I assistive 
device, aiming to validate its design performance and real-world usability, not to demonstrate superiority 
or non-inferiority to other feeding systems.
b) Description of the measures to be taken to minimize or avoid bias, such as randomization, 
concealment of allocation, blinding/masking, and management of potential confounding 
factors. 
This clinical investigation is a non-randomized, non-comparative usability study designed to evaluate 
whether the Obi Gen 3 Medical Robotic Feeding Device conforms to its intended use and meets 
documented user needs. The purpose of the study is not to assess therapeutic effectiveness or to 
compare outcomes across intervention groups but to validate device usability and stakeholder 
satisfaction across real-world settings.
Given the nature and objectives of the study, randomization, blinding, and allocation concealment are 
not applicable. However, several measures will be taken to minimize or avoid bias and manage potential 
confounding factors:
1. Standardized Protocols and Training 
All participants (providers, caregivers, and patients) will engage with the device under a standardized 
study protocol, including consistent onboarding materials, instructional documents, and usage 
expectations (e.g., a minimum of five meals during the trial period). These materials were developed 
based on prior formative feedback and are provided in uniform formats to reduce variability in participant 
experience.
2. Structured Data Collection Tools 

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Usability feedback will be collected using validated instruments (e.g., System Usability Scale, Matching 
Person & Technology framework) and semi-structured interview guides. These tools ensure consistency 
in gathering information, reduce interviewer bias and facilitate comparisons across stakeholder groups.
3. Triangulation of Stakeholder Perspectives 
The study design allows for triangulation of findings by including data from three distinct stakeholder 
groups (providers, caregivers, and patients). This multi-perspective approach reduces the risk of single-
source bias and provides a broader understanding of device usability in real-world contexts.
4. Post-Use Feedback After Trial Exposure
Participants provide their usability ratings and feedback only after completing the one-week trial. This 
approach helps minimize expectation bias and ensures responses reflect the user experience with the 
device.
5. Blinding of Data Analysts (if applicable) 
The Principal Investigator will conduct the data analysis but will not be involved directly in participant 
recruitment or data collection, reducing the potential for confirmation bias during the interpretation of 
results.
Collectively, these measures are designed to support the credibility, reproducibility, and transparency of 
findings from this usability-focused clinical investigation.
c) Primary and secondary endpoints, with rationale for their selection and measurement. If 
applicable, composite endpoints, with rationale for their selection and measurement.
Primary Endpoint 
The primary endpoint of this clinical investigation is to determine whether the production equivalent Obi 
Gen 3 device fulfills its intended use and formally defined user needs across three key stakeholder 
groups: patients, caregivers, and providers. This 
objective under FDA and ISO guidelines for Class I medical devices.
To assess this endpoint, the study uses a mixed-methods approach that includes:
Usability survey responses gathered post-trial via Qualtrics,
Qualitative interview data to capture real-world experiences and
Evidence of independent feeding success (i.e., completion of a minimum of five meals during the 
one-week trial period for patient participants).
Rationale: This endpoint aligns with ISO 13485 and FDA QSR requirements for verifying that a device 
conforms to documented design inputs and intended use in its target environment. Given that the device 
facilitates daily living activities rather than delivers clinical treatment, usability, and stakeholder 
satisfaction are the most relevant performance indicators.

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Secondary Endpoints
Secondary endpoints are designed to provide a multi-dimensional understanding of the user experience 
and support future design refinement and stakeholder-specific training materials. 
These include:
1. Patient Usability will be measured using an adapted version of the Matching Person & 
Technology (MPT) Framework and adult and pediatric versions. The study focuses on 
compatibility between the user and device, perceived benefits, and likelihood of long-term 
adoption. 
2. Caregiver Usability will be measured using the System Usability Scale (SUS) and the Matching 
Person & Technology (MPT) Framework, an adult version adapted for the context of this study. 
Additionally, a few selective questions from the Caregiver Burden index will help to describe this 
stakeholder group to understand better the impact of Obi-Gen 3 use on time demands, emotional 
strain, and caregiving workload. 
3. Provider perspectives and Workflow Integration will be measured using the System Usability 
Scale (SUS) and open-ended feedback. The study will assess ease of device recommendation, 
assessment form clarity, and integration into the service delivery process. 
4. Effectiveness of Training and Support Materials will be assessed via post-trial feedback on the 
©). 
Rationale: These endpoints reflect stakeholder-specific criteria for acceptability, feasibility, and 
usability and were selected based on established frameworks in the assistive technology 
literature.  
d) Methods and timing for assessing, recording, and analyzing variables. 
This clinical investigation employs a mixed-methods approach to assess the usability and user 
experience of the Obi Gen 3 Medical Robotic Feeding Device. Both quantitative and qualitative variables 
will be assessed at multiple timepoints using standardized and non-standardized tools. Data will be 
recorded electronically and analyzed using descriptive and thematic methods.
Key variables to be assessed include:
Usability metrics (efficiency, effectiveness, satisfaction)
Stakeholder-specific experience and acceptance (patients, caregivers, providers)
Functional outcomes related to self-feeding independence 
Psychosocial impact (confidence, autonomy, perceived burden)
Feedback on supporting materials (ease of use of training guides, forms)

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As previously described, these variables will be measured using quantitative surveys and rating scales, 
including the System Usability Scale (SUS) and Matching Person & Technology (MPT) Framework. 
Qualitative data will be gathered through open-ended questions, which are included in the surveys, and 
semi-structured interviews conducted by phone, when applicable.
 
Timing of Assessments 
 Baseline: Screening and in-
© form 
to gather demographics and baseline functional feeding status. 
 During trial: One-week trial of Obi-Gen 3 in home, community, or school settings. Caregivers and 
patients use the device with at least five meals; providers recommend or assess at least one user 
in their practice. 
 Post-trial (~ one week to one month): Qualtrics survey links will be sent to all participants 
(providers, caregivers, patients) to gather information post-trial. Optional telephone interviews 
may be completed within one month of survey completion for additional qualitative feedback. 
 
Data Recording 
 All survey and rating scale responses will be collected electronically via Qualtrics, a HIPAA-
compliant data management platform.
 Qualitative interview notes or transcripts will be recorded and stored securely using encrypted 
formats, with identifiers removed before analysis. 
 
Data Analysis: All analyses will be used to determine whether the design of Obi Gen 3 meets the 
intended use and user needs and to guide product refinement and support resources. 
 Quantitative data will be analyzed using descriptive statistics (e.g., means, standard deviations, 
medians) to assess trends in usability scores across stakeholder groups. 
 
 As a validated instrument, responses to the SUS will be interpreted using established scoring 
thresholds to determine whether usability targets were met. 
 
 Qualitative data will be analyzed using a structured thematic coding approach to identify key 
usability themes, barriers, and suggested improvements. 
 
e) Equipment to be used for assessing the clinical investigation variables and arrangements for 
monitoring maintenance and calibration. 
caregivers in home, school, or community environments and recommended or assessed by providers in 
clinical settings. Each Obi Gen 3 unit used in the investigation is a production equivalent model that has 

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for:
Verifying proper function of all device components (arm, base, controls) before shipment
 
Maintaining a device log to track serial numbers, shipment history, and user assignment
 
 Providing pre-use visual inspection guidance and basic maintenance instructions to participants. 
Because Obi Gen 3 is a non-implantable, non-therapeutic, electromechanical device with no internal 
measurement sensors requiring calibration, no additional calibration procedures are required during the 
investigation. In the rare event of a device malfunction or performance concern, participants will be 
instructed to notify the study coordinator immediately, and the sponsor will either replace the device or 
conduct further investigation as appropriate. 
In addition to the device, the following tools will be used for assessing clinical investigation variables: 
 Obi Gen 3 Assessment Forms (D-FRM-
assessment and workflow documentation) 
 Data Collection Tools including: 
o Qualtrics – a secure, HIPAA-compliant online platform used to distribute and collect all 
electronic surveys, rating scales, and interview responses 
o System Usability Scale (SUS)  
o Matching Person & Technology Framework – adapted 
o Caregiver Burden Index – selected items relevant to feeding support 
All electronic data collection tools (i.e., Qualtrics) are maintained by the vendor and subject to routine 
system monitoring, encryption, and security updates per HIPAA and institutional data security policies. 
f)
Any procedures for the replacement of subjects (generally, not applicable to randomized 
clinical investigations).
This usability study includes patients, caregivers, and providers as stakeholders and does not involve 
treatment allocation or randomization.
As such, formal subject replacement procedures are not applicable. Participants may withdraw from the 
study at any time without penalty, and no individual will be replaced on a one-to-one basis; however, if 
attrition occurs early in the study (e.g. before completion of the minimum trial period or primary usability 
data are collected), the sponsor and study team may continue recruitment to maintain a robust and 
diverse sample that reflects the target user population.
All data from participants who withdraw will be handled according to data management protocols, and 
partial data may be included in the analysis when appropriate and ethically permissible. Efforts will be 

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made to ensure adequate enrollment within each stakeholder group (providers, caregivers, and patients) 
g) Investigation sites: number, location, and, if appropriate, differences in investigation site 
environment. 
This clinical investigation will be conducted through a single-
headquartered in the United States and will serve as the central coordinating site for all study activities.
electronically using a HIPAA-compliant data platform (Qualtrics), enabling participation from individuals 
located throughout the United States. This distributed recruitment and data collection approach 
supports broader geographic and demographic diversity among participants and reflects the real-world 
settings in which the device is intended to be used.
Participants—including providers, caregivers, and patients—will engage with the study in naturalistic 
environments, such as: 
 Home settings (for patients and caregivers), 
 Community settings, including schools or assisted living environments, 
 Clinical settings, where providers may evaluate or support patients using the device. 
The diversity of these environments is intentional and aligns with the purpose of the usability study, 
which is to evaluate device performance in the context of everyday use. The study will capture data on 
how different settings and conditions may impact user experience, device integration, and support 
-person clinical site visits or on-site research infrastructure is required for 
participation, and all stakeholders will be provided with study materials, the Obi Gen 3 device, and 
access to electronic surveys and interviews in a manner consistent with remote, human-centered 
usability testing. 
h) Definition of completion of the clinical investigation (see 8.1). 
The clinical investigation will be considered complete when all enrolled participants have concluded 
their involvement in the study, including: 
 Completion of the required ~1-week home/community trial of the Obi Gen 3 device; 
 Submission of all relevant post-trial surveys via the Qualtrics platform;
 Completion of any scheduled follow-up interviews (if applicable), which may occur up to 1 month 
following survey completion;
 All protocol-specified data collection activities have been finalized, verified, and locked for 
analysis. 
The end of the investigation will also include:

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 Confirmation that no additional participants remain under observation;
 Documentation of any protocol deviations, adverse events, or device-related issues;
 Completion of final data monitoring activities and closure of the Qualtrics data collection system; 
 Submission of a final study report following applicable IRB and sponsor requirements.
A.6.2. Investigational Devices and comparators  
a) Description of the exposure to the investigational device(s) or comparator(s), if used. 
This clinical investigation involves exposure to a single investigational device, the Obi Gen 3 Medical 
Robotic Feeding Device, which is a production equivalent version of a Class I FDA-registered medical 
device intended to assist individuals with upper extremity impairments in self-feeding. Participants in the 
study—including patients, caregivers, and providers—will be exposed to the device during a short-term, 
observational usability trial, which occurs under real-world use conditions (home, school, community, or 
 
All exposure to the device is consistent with its intended purpose and involves no modification to existing 
standards of care or risk to participants. The exposure is limited in duration and is conducted in 
naturalistic settings to allow the device to be evaluated under realistic use conditions.
Patient and Caregiver Exposure: Patients and caregivers will use the Obi Gen 3 device for a period of 
approximately one week. During the trial, users are expected to operate the device for a minimum of five 
meals, though additional use is encouraged to gather meaningful feedback. Participants will use the 
device independently or with caregiver assistance, following a brief orientation via a Quick Start Guide 
(QSG) and Instructions for Use (IFU) provided with the device. Device use is non-invasive and involves no 
physical contact beyond standard utensil-based feeding.  
 
Provider Exposure: Providers (e.g. occupational therapists, speech-language pathologists, assistive 
technology professionals) will interact with the Obi Gen 3 device in the context of: 
Assessing its fit for at least one patient in their caseload, 
 Recommending its use as part of routine practice (if applicable), 
  and Providing feedback based on observation or guided use in their clinical setting. 
The Providers will not operate the device for feeding themselves but will assess functionality, usability, 
and alignment with therapeutic goals. 
 
b) List of any other medical device or medication to be used during the clinical investigation if 
not already specified in the instructions for use. 
- 
investigation beyond what is already specified in the Instructions for Use (IFU) for the Obi Gen 3 Medical 
Robotic Feeding Device. 
c)  Number of investigational devices to be used, together with a justification. 

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This usability study will use ten (10) production-equivalent Obi-
commercialization. 
The selected number is justified based on the following factors: 
 The study will enroll approximately 55–60 participants across three key stakeholder groups: 
providers, caregivers, and patients. 
 The study design includes a 1-week device trial per patient-caregiver dyad, during which each 
device will be rotated and re-used among participants. 
 Cleaning and infection control protocols will be implemented between uses to ensure participant 
safety and device integrity.
 This number allows for redundancy and replacement should a device require maintenance or 
become damaged during the study. 
 The Obi Gen 3's limited-risk profile (FDA and MDR Class I classification) supports the re-use of 
devices across participants, provided proper decontamination procedures are followed. 
 It also ensures sufficient device availability for logistics coordination, shipping, training support, 
and concurrent participation at different study locations. 
This approach balances scientific rigor, operational feasibility, and resource efficiency while supporting 
timely and representative data collection for design validation purposes. 
A.6.3. Subjects 
a) Inclusion Criteria for Subject Selection 
Participants will be recruited from three key stakeholder groups—providers, caregivers, and patients—
who represent the intended users of the Obi Gen 3 Medical Robotic Feeding Device. Inclusion criteria are 
as follows:
Providers -
assessing, or implementing assistive technology, rehabilitation interventions, or feeding-related 
supports. This may include, but is not limited to, occupational therapists (OTs), speech-language 
actively engaged in supporting individuals with self-feeding challenges.
Caregivers - Individuals who provide regular, hands-on support to a person who may benefit from 
using the Obi Gen 3 device. This includes family members, personal care aides, educational 
support staff, or other support personnel who assist with or supervise feeding activities in the 
home, school, or community setting.
Patients: Adults or children aged 5 years or older who require assistive technology to support 
independent or supported self-feeding due to upper extremity motor impairments or related 

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functional limitations. Individuals must have the cognitive and physical ability to participate in the 
one-week usability trial, either independently or with the assistance of a caregiver.
All participants must be able to understand and comply with study instructions and provide consent or 
assent (when applicable) either by themselves or through a legally authorized representative.
 
b) Exclusion Criteria for Subject Selection 
Participants will be excluded from the study if they meet any of the following conditions: 
 Individuals who cannot provide informed consent or assent, either due to legal status, cognitive 
limitations, or other conditions that impair decisional capacity. 
 Individuals with severe cognitive impairments that would preclude meaningful participation in the 
feedback. 
 
-English-speaking individuals, as all study materials—including consent documents, surveys, 
and instructions—are available only in English at this time, and interpreter services are not being 
utilized in this investigation.
 California residents who are new to using Obi. The state of California requires a one-month trial, 
so the one-week timeline will not be feasible for California residents.   
c) Criteria and procedures for subject withdrawal or lost to follow-up
i) 
when and how to withdraw a subject from the clinical investigation or stop the use of 
the investigational device, 
Subjects may be withdrawn from the clinical investigation at any time due to voluntary withdrawal, 
investigator decision, or other unforeseen circumstances. Regardless of cause, all early terminations 
must be documented clearly in the Case Report Form (CRF) (attached to this protocol), including the 
specific reason for withdrawal. The following outlines the criteria and procedures for subject withdrawal:
Early Termination – General Considerations: All early exits from the study will be promptly recorded, and 
the rationale for withdrawal should be documented in the CRF to ensure traceability, transparency, and 
compliance with study oversight requirements. 
Failure During Initial Use - 
-screening and in-office 
assessment that is part of the standard operating procedure will optimize appropriate participant 
selection, they may not be 100% predictive of device compatibility. In some instances, a subject may 
meet pre-screening criteria but be unable to use the Obi Gen 3 device safely or effectively during initial 
use. These cases will be identified early—typically on the first day of the trial—and such individuals will 
be withdrawn from the study. These withdrawals must be clearly documented in the CRF and the reason 
and relevant observational notes. 

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Voluntary Withdrawal of Consent - Subjects (or their legal representatives) have the right to withdraw 
consent and discontinue participation in the study at any time and for any reason, without penalty or loss 
of benefits. If informed consent is withdrawn, no additional data will be collected from the subject 
beyond the point of withdrawal. All data previously collected up to the point of withdrawal may be 
retained and used for analysis unless the subject explicitly requests full data removal, as outlined in the 
consent form. 
Investigator-Initiated Withdrawal - If, at any time during the investigation, the Principal Investigator 
-being or safety—
or for other clinical, behavioral, or protocol-related reasons—the subject may be withdrawn from the 
study. The justification for investigator-initiated withdrawal must be documented in the CRF, and the 
subject (or caregiver) must be informed of the decision following ethical and regulatory standards.
Subject Death - 
becoming aware of the event. Death will be recorded as a reason for early study termination in the 
compliance with good clinical practice and transparency.
ii.) documentation of efforts to be made to trace subjects that are lost to follow-up and possible 
reasons 
This study involves minimal risk and a short duration of participation for most subjects (approximately 
one week), with optional follow-up within one month for those whose survey responses warrant an 
optional semi-structured interview conducted by telephone. Despite this, the research team recognizes 
the importance of accounting for all enrolled subjects and will make reasonable efforts to trace those 
lost to follow-up. If a participant fails to complete the post-trial survey within one week following the 
designated trial period, the following steps will be taken:
Reminder Emails/Text Messages: The HIPAA-compliant Qualtrics platform will send an initial 
automated reminder email and/or text message.
Follow-Up Contact: If no response is received within 3–5 business days, study personnel will 
make up to two additional attempts to reach the participant by email, text, or phone. (if contact 
information is available).
Documentation: All follow-up attempts will be documented, including date, time, method of 
contact, and any responses received.
Optional Withdrawal Confirmation: If a participant expresses that they no longer wish to 
continue, this will be documented, and their status will be updated as voluntarily withdrawn.
Data Retention: Any partial data collected before loss to follow-up will be retained and analyzed 
per IRB approval and applicable data use procedures.
Possible Reasons for Loss to Follow-Up May Include:
Changes in caregiver or patient availability

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 Technology-related challenges (e.g., issues with email, survey links) 
 Medical changes or competing life demands
 Unreachable contact information (e.g., email address no longer active) 
Given the minimal-risk nature of the study, no intensive or intrusive tracking methods (e.g., home visits) 
will be used. Participants will be informed during the consent process that follow-up is optional and that 
they may discontinue participation at any time without consequence. 
iii.) whether and how subjects are to be replaced.
Given the nature of this usability study and the relatively small, targeted sample size, subjects who 
withdraw voluntarily or are lost to follow-up during the study period will not be replaced. However, if a 
subject withdraws before completing any meaningful portion of the data collection (e.g., before starting 
the Obi Gen 3 trial period or before completing in-office assessments), the study team may recruit an 
additional participant to maintain representation across stakeholder groups (providers, caregivers, and 
patients). Replacement will occur only as needed to ensure data completeness or demographic diversity 
 
d) Point of enrollment.  
Participants are considered enrolled in the study after providing informed consent (or assent, where 
applicable) and after completing an initial in-office clinical assessment by a qualified provider (typically 
he 
study and the beginning of data collection activities using the HIPAA-compliant Qualtrics platform. 
e) Point of randomization, if applicable. Randomization does not apply to this investigation. 
f) Total expected duration of the clinical investigation. 
The total expected duration of this clinical investigation is approximately three (3) months, spanning from 
April 2025 through June 2025. This time frame includes: 
 Pre-screening, recruitment, and enrollment of participants across all stakeholder groups 
(providers, caregivers, and patients), 
 Completion of a one-week home/community trial of the Obi Gen 3 device by up to 60 participants, 
 Post-trial survey and interview data collection, 
 Final data analysis and reporting of usability outcomes. 
The duration also accommodates staggered enrollment and rolling recruitment, which will occur on a 
first-come, first-served basis until target sample sizes are reached. The study timeline may be adjusted 
slightly based on participant availability and operational needs but is not expected to exceed the nine-
month window. 
 
 

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g) Expected duration of each subject's participation.
Each subject's participation in the clinical investigation will vary based on their role (provider, caregiver, 
or patient) and level of engagement. The core duration of participation for all enrolled stakeholders is 
approximately one week, corresponding to the required trial period of the Obi Gen 3 Medical Robotic 
Feeding Device in a home, school, or community setting.
 Patients and Caregivers: Participants are expected to use the device for at least five meals over a 
one-week period. During this time, they will use the device in real-life contexts and later complete 
post-trial surveys and optional follow-up interviews. 
 Providers: Participating providers are expected to conduct an initial in-office assessment to 
determine patient suitability for the Obi Gen 3, recommend at least one patient for trial use, and 
provide feedback based on their clinical observation. Their involvement also includes completing 
a usability survey post-trial and, if applicable, participating in a brief follow-up interview.
Follow-up through telephone-based semi-structured interviews may be conducted within one month to 
further clarify or expand responses to open-ended questions. These interviews will be scheduled within 
one month of the trial's completion. 
h) Number of subjects required to be included in the clinical investigation, and where needed, 
anticipated distribution of enrolment among the participating investigation sites. 
A total of 60 participants will be recruited using flyers and word-of-mouth strategies
 
i)
Estimated time needed to select this number (i.e. enrolment period). 
The estimated time required to enroll the whole sample for this usability study is 4–5 weeks, given 
the study's targeted outreach strategy, electronic recruitment methods, and existing professional 
stigative team. Recruitment materials, 
including flyers and direct outreach, will be distributed electronically and through participating 
service providers to expedite enrollment. 
 
 
Stakeholder Group
Target Sample Size 
Providers [Occupational Therapists (OTs), Assistive Technology 
Professionals  (
other relevant  providers) 
20 in various 
practice settings
Caregivers (family members, aides, support personnel)
20 (5 for adults,15 for children)
Patients (adults and children using Obi Gen 3)
20 (5 adults, 15 children)

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j)
Relationship of investigation population to target population.
The study population has been carefully selected to reflect the intended users and stakeholders 
of the Obi Gen 3 Medical Robotic Feeding Device. The target population includes: 
 Patients (adults and children ages five (5) years and older) with upper extremity 
impairments who require assistance with self-feeding, 
 Caregivers (family members or aides) who assist with feeding tasks and  
 Providers (e.g., occupational therapists, speech-language pathologists, assistive 
technology professionals) who assess, recommend, or support use of assistive 
technologies like Obi.
These participants represent the user base for whom the device is designed, ensuring that 
usability feedback is directly relevant to real-world performance and future product deployment.
k) Information on vulnerable, pregnant, and breastfeeding population, if applicable.
The study includes children (ages five (5) years and older) who are considered a vulnerable population 
under federal human subjects research regulations. As such, the study will follow all applicable 
safeguards:
 Assent will be obtained from pediatric participants when developmentally appropriate.
 
 Parental or guardian permission will be required prior to participation. 
 
 Study procedures are non-invasive and pose minimal risk.
The study does not intentionally include pregnant or breastfeeding individuals as a target subgroup. 
However, if an eligible participant (e.g., caregiver or provider) happens to be pregnant or breastfeeding, 
they will not be excluded unless participation presents a specific risk, which is not anticipated in this 
minimal-risk usability study.
A.6.4 Procedures
a) Description of all the clinical investigation-related procedures that subjects undergo during 
the clinical investigation, including any deviation from standard clinical practice.
Recruitment: 
qualification per its internal prospecting activities. 
Triadic Recruitment: Providers, caregivers, and patients will be recruited together when possible, to 
enhance data richness.

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Pre-Screening: Interested Individuals recruited will then be pre-
Procedures, Pre-Screening topics. 
In-Office Assessment: Also part of SOP220, for screened subjects, their provider is sent a device for an 
in-office device assessment. During this time, the  assesses whether the patient can use the device 
-FRM-021, Obi Medical Device 
Enrollment: The patients who pass pre-screening criteria per SOP220, and/or their legal authorized 
Providers and Caregivers will also be invited to enroll in the stud
sign both the ICF and study agreement, are considered enrolled in the study (Subject). Patients and/or 
their legal representative will be allowed ample time for review, consideration, and decision to 
parti
signing the ICF, the subject is assigned a sequential study number. These numbers are used for subject 
identification. The data platform, Qualtrics (HIPAA compliant) will be used to electronically enroll 
subjects.
Obi Trial: The screened subjects who pass the In-Office Assessment will take Obi home for a 7-day in 
then undergo a follow up office assessment with their provider. The providers will complete the 
-up assessment. 
Data Collection & Endpoints: Following the ~one week trial, subjects will be provided electronic links 
via Qualtrics to complete. 
b) Description of those activities performed by sponsor representatives (excluding monitoring) 
Sponsor representatives involved in this clinical investigation will engage in select study activities that 
support study implementation and participant engagement, while maintaining a clear separation from 
regulatory monitoring functions. 
serve as a designated sponsor representative. In this role, she will perform the following non-monitoring 
responsibilities in direct support of the Principal Investigator, Dr. Andrea Fairman: 
 Assisting with Participant Communication: Ms. Keeton will support recruitment and 
communication with potential and enrolled participants (providers, caregivers, and patients) 
throughout the study. 
 
 Obtaining Informed Consent: Under the direction and oversight of the Principal Investigator, Ms. 
Keeton will assist in obtaining informed consent and assent (as applicable) from all stakeholder 
groups using the approved Qualtrics-based electronic consent platform. All consent procedures 
will follow the IRB-approved protocol and adhere to ethical and regulatory guidelines outlined in 
21 CFR Part 50 and institutional policies. 
 

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 Providing Study Materials and Logistics Support: Ms. Keeton may coordinate the delivery of 
study-related materials (e.g., recruitment flyers, instructions for use, Quick Start Guides, and 
study devices) and assist in providing technical support or clarification regarding study 
procedures or documentation tools. 
 
 Direct Contact with Participants: Ms. Keeton may have direct interaction with participants to 
provide instructions, answer procedural questions, and confirm receipt of study equipment and 
materials. However, she will not be directly involved in clinical assessments, data analysis, or 
independent study monitoring. 
logistics and communication tasks necessary for study implementation. All clinical decisions, eligibility 
determinations, and data analyses will remain under the control of the Principal Investigator and 
designated study personnel. These activities have been disclosed in the IRB submission and are being 
conducted in compliance with applicable ethical and regulatory standards. 
c) Any known or foreseeable factors that can compromise the outcome of the clinical 
investigation or the interpretation of results.
Several foreseeable factors may influence the outcome of this usability-focused clinical investigation or 
impact the interpretation of results. These factors are typical of real-world, mixed-methods usability 
research and have been considered in the study design to minimize potential compromise to data 
integrity and outcome interpretation: 
1. Variability in User Experience and Abilities 
The study population includes individuals with diverse diagnoses, functional abilities, and prior 
exposure to assistive technologies. This heterogeneity may introduce variability in how 
participants interact with the Obi Gen 3 device, potentially influenci
reflects real-world conditions, it may also limit the generalizability of results. 
 
2. Short Trial Duration 
The initial one-week trial period, while appropriate for assessing first impressions and short-term 
usability, may not fully capture longer-term use patterns, adaptation curves, or sustained 
satisfaction. 
 
3. Subjective Nature of Usability Metrics
The surveys used in the study rely on self-report or stakeholder perceptions. These are inherently 
subjective and may be influenced by participant expectations, mood, or environmental factors 
during the trial period.
 
4. Potential for Response Bias
Given that participants know they are using a novel assistive device provided by a sponsor, there 

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is a risk of social desirability bias, especially among caregivers and providers who may want to 
provide favorable feedback. This risk will be mitigated through anonymized survey responses and 
neutral interview techniques. 
5. Technological and Environmental Variability 
Because the trial takes place in participants' home, school, or community settings, external 
variables (e.g., table height, feeding environment, caregiver supervision) may affect device use 
and outcomes. These contextual factors may be difficult to control or fully account for in analysis.
6. Small Sample Sizes in Subgroups
pediatric patients or specific provider types) may be too small to detect nuanced differences or 
trends. This could limit the ability to draw robust comparisons across user types. 
7. Missing or Incomplete Data
As with any study involving remote data collection, there is a risk of incomplete surveys, missed 
interviews, or dropouts. The study team has implemented follow-up reminders and contact 
protocols to maximize retention and response rates.
d) The Methods for addressing these factors in the clinical investigation
Despite these foreseeable factors, the mixed-methods approach, inclusion of validated usability tools, 
and efforts to mitigate bias strengthen the reliability of the study and support meaningful conclusions 
about the Obi Gen 3 device's real-world usability and design readiness. This usability study has been 
designed to address potential sources of bias, variability, risk, and data quality concerns through a 
combination of structured procedures, validated instruments, and robust data collection practices. The 
following methods have been implemented to ensure scientific rigor, participant protection, and the 
validity of study findings:
 Standardized Training and Materials
All participants—including providers, caregivers, and patients—will receive consistent 
onboarding materials (e.g., Quick Start Guide, Instructions for Use) to ensure a common 
understanding of device setup and use. This minimizes variability in use procedures across 
stakeholder groups and supports equitable engagement with the device.
 
 Use of Validated Frameworks 
The study utilizes established and validated tools, including the System Usability Scale (SUS), 
Matching Person & Technology (MPT) Framework to assess usability across diverse participants. 
These tools allow for meaningful interpretation of findings and reduce subjective bias.

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 Mitigation of Risks 
Identified study risks—such as user fatigue, frustration, and data privacy concerns—are managed 
through:  
 Brief participation windows (e.g., 1-week trial with a minimum of 5 meal uses),  
 Technical support availability,  
 Secure data collection via the HIPAA-compliant Qualtrics platform,  
 Clear data management protocols for de-identification and limited access 
 
 Minimization of Confounding Variables 
 Participants are pre-screened using a standardized process (SOP220) to ensure that only 
individuals meeting inclusion criteria are enrolled. Demographic and baseline data, including 
functional feeding status and assistive technology experience, are collected to allow subgroup 
analyses and account for potential confounders in interpretation. 
 
 Triangulation of Data (Mixed Methods) 
 A mixed-methods design integrates both quantitative data (e.g., rating scales) and qualitative 
data (e.g., semi-structured interviews), allowing for comprehensive understanding and internal 
validation of usability findings across stakeholder perspectives. 
 
 Consistent Scheduling and Follow-Up 
Data collection occurs at fixed time points following the trial period (e.g., immediately post-trial 
and optional 1-month follow-up), which supports consistent comparison across users. All 
interviews are conducted using a semi-structured guide to reduce interviewer variability. 
 
 Independent Oversight and Conflict of Interest Management 
 To preserve data integrity and transparency, a conflict of interest management plan is in place for 
the Principal Investigator. This includes institutional oversight and disclosure of funding and 
sponsor relationships in study materials and reporting. 
 
e) The follow up period during the clinical investigation shall permit the demonstration of 
clinical performance, effectiveness or safety over a period of time sufficient to represent a 
realistic test of the investigational device and allow any risks associated with adverse device 
effects to be identified and assessed.  
The ~one week follow-up period for this clinical investigation has been designed to allow for a realistic 
and contextually appropriate assessment of the Obi Gen 3 Medical Robotic Feeding Device efficacy as it 
relates to usability in typical use environments (e.g., home, community, or clinical settings). 
device is not intended for therapeutic intervention and poses minimal risk as a Class I medical device, 
the selected timeframe is sufficient to evaluate its usability, clinical performance, and user experience 
across diverse stakeholder groups.  

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The primary follow-up period consists of a ~one-week trial, during which participants (patients and 
caregivers) are expected to use the device across a minimum of five meal sessions. This time frame 
reflects common practice in assistive technology evaluation, enabling users to become familiar with the 
device and providing adequate exposure to assess:
 Effectiveness in supporting independent self-feeding,
 User satisfaction and ease of use,
 Integration into existing routines or caregiving workflows, and
Identification of any usability challenges or design limitations.
f)
Address what specific medical care is appropriate to be provided for the subjects after the 
clinical investigation has been completed, if applicable.
and Class I nature.  
g) Address recommended follow-up for the subjects after the clinical investigation has been 
completed.
clarification or expansion of open-ended survey question responses. Risks such as user fatigue, 
frustration, or device misuse are most likely to emerge within this timeframe. The structured follow-up, 
including post-trial surveys via Qualtrics and optional phone interviews, will ensure timely identification 
and documentation of any unexpected adverse device effects, even though none are anticipated. 
h) Address the final disposition or potential future use of samples obtained from subjects, if 
applicable. 
Devices used in during the study will be returned to 
, visually inspected, functionally 
evaluated, cleaned, disinfected and otherwise reconditioned as needed in accordance with 
SOP120. These devices will then be approved to enter the 
be used with new prospective customers. 
A.6.5 Monitoring Plan
General outline of the monitoring plan to be followed, including access to source data and the extent of 
source data verification planned.
There is no official monitoring plan developed. However, to ensure adequate monitoring of the study, the 
to, allowing the assessment of facilities utilized for this study, providing access to subject report forms, 
and subject medical records reasonably requested. 
 
 

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A.7.
Statistical Design and Analysis
clinical investigation shall cover the following.
a) Analysis population (e.g. intention-to-treat, per-protocol, as-treated) and procedures that 
take into account all the data. 
This clinical investigation is a non-randomized, non-comparative, mixed-methods usability study 
intended to evaluate whether the production equivalent Obi Gen 3 robotic feeding device meets 
the documented user needs and intended use across stakeholder groups. As such, the primary 
focus of the statistical design is on descriptive and qualitative analysis rather than hypothesis 
testing or inferential statistics.  
All participants who complete informed consent and the survey be included in the analysis 
population. Given the non-interventional nature of the study, the analysis will follow an as-treated 
approach, with all available data from each stakeholder group included in the final 
analysis.Participants who after consent but before completing any trial procedures will be 
excluded from the analysis population. Missing data will be documented but not imputed, as the 
primary intent is to assess observed usability and feedback trends.
b) Descriptive statistics of baseline data, treatments, safety data and where applicable, 
primary and secondary endpoints.
Descriptive statistics will be used to summarize:
Baseline demographic and clinical characteristics, including age, gender, 
diagnosis, and prior experience with assistive technology.
 Trial participation metrics, including duration of use and number of meals 
completed. 
Survey and rating scale responses, including usability ratings (e.g., System Usability 
Scale [SUS], Caregiver Burden Index, Matching Person & Technology assessments).
For numeric responses, means, standard deviations, medians, and ranges will be 
reported. For categorical data, frequencies and percentages will be presented.
Semi-structured interviews and open-ended survey responses will be analyzed using 
content analysis to identify recurring themes related to usability, satisfaction, and device 
integration into daily routines. Data will be coded independently by at least two trained 
reviewers, and discrepancies will be resolved through discussion to ensure thematic 
reliability.
c) Analytical procedures including measures of precision such as confidence intervals, if 
applicable.

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-validation focus, no formal hypothesis testing or inferential 
statistics are planned. However, where appropriate, confidence intervals (e.g., 95%) may be used 
to describe the precision of mean usability scores or other key quantitative measures. These 
measures will help contextualize findings and inform decision-making for potential design 
improvements or user support strategies.
The primary outcome—validation of the device's usability and fulfillment of user needs—will be 
assessed based on aggregated stakeholder ratings and thematic saturation in qualitative 
responses. Results will be stratified by stakeholder groups (patients, caregivers, providers) to 
support subgroup comparisons where appropriate. 
d) The significance level and the power of primary endpoint(s) and the overall statistical testing 
strategy, if applicable. 
If a hypothesis is tested, a significance level alpha 0,05 (two-sided) and 0,025 (one-sided) and 
powers between 0,8 and 1 minus alpha need no justification. Depending on the characteristics of 
the investigational medical device or the clinical investigation, higher or lower levels of 
significance can be used. Examples of justifications include but are not limited to: product 
standards, scientific reasons or discussion with regulatory authorities. 
e) Sample size calculation and justification taking into account: 
1) all relevant clinical data on outcome variable and effect size, if applicable; 
Sample size will be determined and justified using guidance issued by the FDA for human 
factors validation testing (FDA], 2016). The following are excerpts from Appendix B, 
Considerations for Determining Sample Sizes for Human Factors Validation Testing:  
“If the device has more than one distinct population of users, then the validation testing 
should include at least 15 participants from each user population. The FDA views user 
populations as distinct when their characteristics would likely affect their interactions with 
the device or when the tasks performed on the device would be different. For example, 
some devices will have users in different age categories (pediatric, adolescent, adult, or 
geriatric) or users in different professional categories (e.g., health care provider, lay user); 
other devices will have users with different roles (e.g., installers, healthcare providers with 
unique specialties, or maintenance personnel).” 
“Since the parameters needed to determine sample size cannot be estimated easily or 
cannot be estimated at all prior to testing, a sample of 15 people to detect most of the 
problems in a user interface constitutes a practical minimum number of participants for 
human factors validation testing. This sample size theoretically provides the best 
possibility of detecting user interface design flaws while limiting the amount of resources 
required.” 

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“Thus, although a 15-participant minimum is suggested, a larger sample size might be 
beneficial if a thorough analysis of the product, or previous knowledge about the product 
and/or similar systems, indicates a need.”
2) assumptions of expected outcomes across treatment groups, if applicable;
not applicable
3) adjustments due to any pre-planned interim analyses, if applicable; 
not applicable 
4) detectable effect size and non-inferiority margin, which shall be smaller than the 
detectable effect size and justified with reference to the effect of the comparator, if 
applicable; 
 not applicable 
5) randomization allocation ratio (e.g. 1:1, 1:2), if applicable;  
not applicable 
6) expected drop-out rate, such as withdrawal, lost to follow-up, death (unless death is 
an endpoint).
Given the short duration and minimal risk nature of this usability study, the expected drop-out rate is 
anticipated to be low (less than 10%). Participants will be engaged for a one-week home or community-
based trial of the Obi Gen 3 device,. The limited time commitment, non-invasive nature of participation, 
and flexibility of remote data collection (via Qualtrics and telephone interviews) are expected to support 
high retention. 
Potential reasons for early withdrawal or loss to follow-up may include: 
-up activities
 
 Health-related issues or changes in caregiving responsibilities 
 
Technological issues or accessibility barriers (e.g., inability to access electronic surveys)
 In rare cases, discomfort or dissatisfaction with the device 
Because the study does not involve treatment, diagnostic procedures, or invasive interventions, death is 
not anticipated and is not an endpoint. Any withdrawal or loss to follow-up will be documented with 
reason, when available. Data collected prior to withdrawal will be included in the analysis, consistent 
with an as-treated approach.

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f)
The rationale for the number of procedures to be performed by a single user as part of the 
learning curve and how these data are to be analysed, if applicable.
Given that this investigation evaluates the usability of a robotic feeding device designed for individuals 
with upper extremity impairments, caregivers, and providers, it is important to account for the initial 
learning period associated with device setup, operation, and integration into daily routines. The one-
week trial period with a minimum expectation of five completed meals per patient/caregiver dyad is 
designed to reflect a realistic and sufficient exposure to allow users to become familiar with the device 
and overcome early learning curve effects. 
This threshold was selected based on preliminary feedback from internal evaluations and stakeholder 
consultations, which indicated that users typically require 3–5 sessions, to feel comfortable with basic 
functions (e.g., powering on, positioning the spoon, switching food compartments). For providers, the 
requirement to recommend and assess at least one patient supports evaluation of the device within their 
existing workflow, allowing observation of setup, training, and follow-up in a practical setting. 
Although this study does not include formal repeated-measures testing or time-stamped use logs, 
reported experience over multiple uses (i.e., across several meals and settings) will provide insight into 
how effectively users can learn to operate the device independently. This data will inform training 
recommendations and design refinements to support intuitive, low-burden use in real-world 
environments. 
g) Pass/fail criteria to be applied to the results of the clinical investigation. 
As a design validation study, the primary objective of this clinical investigation is to determine whether 
the Obi Gen 3 production equivalent device meets its formally documented user needs and intended use 
across three key stakeholder groups: patients, caregivers, and providers. The pass/fail criteria are based 
on usability outcomes aligned with ISO 13485 and FDA design validation requirements. The following 
: 
Primary Endpoints: Acceptance criteria is based on safety and quality risk (see IFD-DES-054-1, Design 
Validation Plan, and IFD-DES-054-
involves more than just human subject testing. This CIP covers only the human subject portion.
Intended Use: For all subjects that complete the 1-week trial, the following must be met: 
 ICF performance qualifier for Functional Eating must drop at least one severity level (ex. 
 
 
Adverse Device Effect (USADE). 
User Needs: For all subjects that complete the 1-week trial, 50% of respondents must be in favor that 
the requirement has been fulfilled (see IFD-DES-051-1 Validation Plan) 

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If the investigation meets or exceeds these thresholds across all stakeholder groups, the design will be 
deemed to have passed and is considered validated. If one or more criteria are not met, the results will 
be analyzed to determine if design modifications, additional training resources, or workflow adjustments 
are necessary prior to commercialization.
h) The provision for an interim analysis, criteria for the termination of the clinical investigation 
on statistical grounds, where applicable. 
This clinical investigation is designed as a non-randomized, non-comparative, mixed-methods usability 
study with a modest sample size and descriptive analytic approach. As such, no formal interim analysis 
is planned, and no statistical stopping rules are defined.
Given the exploratory nature of the study and its focus on collecting usability and user experience data 
from stakeholder groups (providers, caregivers, and patients), data will be monitored periodically for 
completeness, diversity of responses, and thematic saturation in qualitative data. These periodic 
reviews will serve quality assurance purposes and support ongoing project planning, but they will not 
serve as formal interim analyses for statistical decision-making. The study is not powered to detect 
statistical differences, and there is no intention to perform comparative analyses or draw inferential 
conclusions. Therefore, termination of the clinical investigation on statistical grounds is not applicable. 
However, the study may be terminated early for administrative, logistical, or ethical reasons, at the 
discretion of the Sponsor. 
i) Management of bias and, when randomization, matching, or blinding are applied, plan for 
assessment of success thereof. 
This clinical investigation is a non-randomized, mixed-methods usability study conducted to evaluate 
whether the Obi Gen 3 production equivalent device meets documented user needs and intended use. 
The design reflects a real-world, observational approach that prioritizes ecological validity over 
experimental control. Randomization, matching, and blinding are not applicable to the design or 
objectives of this study, no formal assessment of the success of these methods is planned. Instead, the 
focus remains on implementing procedural safeguards and objective analytic approaches to support the 
integrity of findings. However, several strategies will be employed to minimize potential sources of bias 
and enhance the credibility of findings: 
Selection Bias - To reduce selection bias, recruitment efforts will include a triadic strategy involving 
providers, caregivers, and patients. Participants will be enrolled from diverse clinical and caregiving 
contexts, and purposeful sampling will be used to ensure representation across age, diagnosis, and 
experience levels. Pre-screening will follow standardized procedures (SOP220), and inclusion/exclusion 
criteria will be consistently applied.
Performance and Observer Bias - 
the usability intervention, standardized instructions, materials, and procedures (e.g., Quick Start Guide, 
assessment forms) will be used across all participants to reduce variability. providers conducting in-

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office assessments will follow a pre-established protocol, and all qualitative interviews will be 
conducted using a semi-structured guide to minimize interviewer influence.
Response Bias - To mitigate social desirability or expectancy effects in surveys and interviews, 
participants will be informed that there are no right or wrong answers and that their honest feedback—
positive or negative—is valued. Electronic data collection using Qualtrics ensures investigator bias 
cannot be introduced in the data collection of the survey responses, particularly from caregivers and 
patients. 
j)
Management of potential confounding factors (e.g. adjustment, stratification, or stratified 
randomization). 
As this is a non-randomized, observational usability study, no randomization or formal control group is 
used. However, several measures will be implemented to identify, minimize, and account for potential 
confounding factors that could influence the usability and user experience outcomes. To manage 
variability in perspectives and experience, participants will be stratified into three predefined 
stakeholder groups:
 
 
 
 Caregivers (e.g., parents, aides, support personnel) 
 
 Patients (adults and children using Obi Gen 3)
Data will be analyzed separately within these strata to prevent confounding across roles and to allow 
tailored interpretation of usability from each unique perspective. 
k) Description of procedures for multiplicity control and adjustment of error probabilities, if 
applicable.
This  study is not designed to test multiple formal hypotheses or to evaluate statistical significance 
across treatment arms or outcomes. Therefore, no multiplicity adjustments or formal procedures for 
controlling Type I or Type II error rates are planned. The focus of the analysis is on descriptive statistics 
and qualitative feedback to characterize usability outcomes across stakeholder groups (patients, 
ey 
are intended to describe measurement precision, not to support inferential claims.Given this context, 
error probability control methods such as Bonferroni correction, false discovery rate (FDR) adjustments, 
or family-wise error rate control are not applicable to the design or analysis of this investigation.
l) The specification of subgroups for analysis, if applicable, or if response to treatment is 
expected to be different in these groups. 

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Although this study is not powered to detect statistically significant differences between groups, 
subgroup analysis will be conducted to explore potential differences in usability perceptions and 
experiences across key stakeholder groups and user characteristics. The following subgroups will be 
descriptively analyzed: 
 Stakeholder Type: 
o providers 
 
o Caregivers (adult and pediatric support persons)
 
o Patients (adult and pediatric device users) 
 
 Age Group of Patient Participants: 
 
o Pediatric (ages 5–17) 
 
o Adult (ages 18 and older) 
 
 Experience with Assistive Technology: 
 
o Participants with prior experience using  earlier versions of Obi 
 
o Participants with no prior experience using Obi 
These subgroups are specified to assess whether perceptions of usability, burden, satisfaction, or 
integration into routine practice differ based on clinical role, age, or familiarity with similar devices. It is 
anticipated that these factors may influence how users interact with Obi Gen 3 and interpret its usability. 
-specific trends may inform future 
design enhancements, training material development, or targeted implementation strategies.
m) Management, justification, and documentation of missing, unused or spurious data, 
including drop-outs.
Given the usability-focused, non-interventional design of this clinical investigation, the approach to 
managing missing, unused, or spurious data will prioritize transparency, traceability, and context-based 
interpretation rather than imputation or statistical correction.
Missing Data - All efforts will be made to minimize missing data by:
 Using structured and user-friendly electronic data collection tools (Qualtrics), 
 Providing reminders for survey completion, and

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 Offering support to participants during the trial period.
withdrawal, technical issues, non-response) will be recorded in the study database. Missing data will not 
be imputed, as the primary goal is descriptive analysis rather than inferential statistical modeling. 
Analyses will be conducted using available data only, and the extent of missingness will be reported for 
each data element.
Unused or Incomplete Data - Incomplete survey responses or interviews that do not meet minimal 
content thresholds (e.g., <50% of questions answered) may be excluded from individual item-level 
analysis but will be retained in the dataset for auditability. The rationale for excluding such data will be 
documented in the data analysis plan and in the final study report.
Spurious or Implausible Data - Any values that are clearly spurious (e.g., internal inconsistencies, out-of-
range responses) will be flagged during data quality checks. If these data cannot be resolved through 
source verification (e.g., interview notes, metadata review), they will be excluded from analysis and 
annotated accordingly in the dataset with justification.
Participant Drop-outs - Participants who withdraw from the study after enrollment will be asked, if willing, 
to provide a brief reason for withdrawal. Drop-outs will be tracked, and their status will be clearly 
documented in the final dataset. Data collected prior to withdrawal will be included in the analysis 
unless the participant requests removal of their data per the informed consent agreement. The rate and 
pattern of drop-outs or early discontinuation will be described in the final study report to assess 
potential biases or operational challenges affecting the usability evaluation.
 
n) Exploratory analysis and sensitivity analysis (e.g. to explore robustness of results of primary 
and secondary analysis with respect to different methods used for handling missing data), if 
applicable.
o) Procedures for reporting any deviation(s) from the original statistical analysis plan.
Any deviation from the original statistical analysis plan (SAP), whether related to the analysis population, 
analytical methods, handling of missing data, or presentation of results, will be documented in the
protocol deviation log and addressed in the final clinical investigation report.
If deviations are necessary during the course of data analysis—such as the inclusion of alternative 
summary measures, subgroup analyses not originally specified, or adjustments to account for 
unforeseen data collection challenges—these will be:
Clearly documented with a justification for the change,

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 Dated and signed by the responsible investigator or data analyst,
 Reviewed by the principal investigator and, if applicable, the sponsor, and 
 Reported transparently in the final report, along with the impact of the deviation on the 
interpretation of the study outcomes.
All such deviations will be made prior to unblinding or final data lock to ensure analytical integrity and 
avoid bias in interpretation. Because this is an exploratory usability study using descriptive and 
qualitative methods, formal pre-specification of statistical hypotheses is limited; however, the principles 
of transparency, traceability, and justification will be upheld for any post hoc analytical decisions.
p) For multicentre clinical investigations, a strategy for handling the potential imbalance of the 
numbers of subjects across investigation sites. 
ot applicable. This study involves a single site. 
q) A strategy for pooling data, if applicable. 
ot applicable based on the study design.  
A.8. 
Data Management 
a) Methods (e.g. CRF) for data entry and collection. 
All data unrelated to normal company processes (see SOP220) will be collected and managed 
through Qualtrics. Data on these assessment forms will be monitored/queried by the principal 
investigator. Information and questionnaires completed by the subject or the investigator and 
collected by study site and related study conduct will be considered source documents. Other 
records that may be considered source documents are hospital records, progress notes, lab 
results, clinic charts, test results, autopsy results (if any), any note related to AEs. A print-out of 
the eCRF cannot be used as a source document.  The investigators and/or their designee are 
responsible for ensuring the accuracy, completeness, and timeliness of data entry. Data from 
these assessment forms will be used in analysis of study results. Data collection, entry and 
appropriate reporting is the responsibility of the supervision of the principal investigator. All 
participant information will be aggregated and de-identified.  
b) Procedures used for CRF tracking, data review, database cleaning, and issuing and resolving 
data queries. Specifically, timely, and reliable processes for recording data and rectifying 
errors and omissions, medical coding uniformity, and reconciliation, if applicable, are 
necessary to ensure delivery of a quality database and the achievement of the clinical 
investigation objectives through the implementation of the planned analysis. 
All changes made to the data will be tracked, recording the current value, previous value, reason 
for change, date timestamp of data change and identification of the person who changed the 
data.   

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c) Procedures for verification, validation, and securing of electronic clinical data systems, if 
applicable.
All electronic clinical data for this study will be collected and managed using Qualtrics, a HIPAA-
compliant, cloud-based data collection platform. Qualtrics has been selected based on its capabilities 
to support secure electronic survey distribution, structured data input, and real-time monitoring of study 
responses across multiple stakeholder groups. The following procedures ensure verification, validation, 
and data security:
 All electronic surveys and forms (e.g., System Usability Scale, Caregiver Burden Index, Matching 
Person & Technology assessments) will be programmed and reviewed by the Principal 
Investigator (PI) personnel with experience in Qualtrics configuration and human subjects 
research. 
 Internal testing procedures will be conducted prior to study launch to verify that skip logic, 
branching, scoring algorithms, and response piping function correctly across all instruments. 
 A validation checklist will be completed to confirm alignment with the approved study protocol 
and data collection requirements. This includes verifying data field accuracy, response ranges, 
and user interface usability for all participant types. 
Qualtrics is certified under HITRUST, ISO 27001, and FedRAMP, and is hosted on secure, encrypted 
servers that comply with the U.S. Health Insurance Portability and Accountability Act (HIPAA) and GDPR 
r higher) and at rest, ensuring the protection of 
sensitive information submitted by participants. Access to the Qualtrics data dashboard is restricted to 
authorized research personnel only, with role-based permissions and two-factor authentication (2FA) 
enforced. Audit logs are automatically generated and maintained by the platform to track all system-
level and user-level interactions with the data.
d) Procedures to maintain and protect subject privacy.
All subject data will be de-identified or coded using unique participant identifiers at the time of 
datasets. Only authorized study personnel will have access to the master list that links identifiers to 
participant names, and this list will be stored in a secure, password-protected location accessible only 
to the Principal Investigator and designated research staff. All electronic data, including surveys and 
interview responses, will be collected using Qualtrics, a HIPAA-compliant, encrypted web-based 
platform. Data transmission will occur over secure (HTTPS) channels, and data will be stored on secure 
servers with access restricted by user roles and passwords.
For remote interviews, participants will be informed in advance about the nature of the questions and 

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made without explicit permission, and any identifiable audio content will be transcribed, de-identified, 
and deleted upon completion of transcription and verification.
All research team members will complete training in human subjects protections and data 
confidentiality. Physical materials (e.g., consent forms mailed or printed) will be stored in locked 
cabinets in secure, access-controlled facilities when not in use. Results will be reported only in 
aggregate or in a manner that prevents re-identification of individual participants.These measures 
ensure that participants' privacy is protected throughout their involvement in the study, and that data are 
handled according to the highest ethical and regulatory standards. Upon study completion, all data will 
be exported and stored on encrypted, access-controlled institutional servers for long-term archiving in 
accordance with IRB and sponsor requirements.
e) Methods for database locking at the start of the analysis and storage upon completion of the 
clinical investigation.
All study data will be collected and managed using Qualtrics, a secure, HIPAA-compliant electronic data 
capture system. Prior to initiating formal data analysis, the following steps will be taken to ensure the 
integrity and completeness of the dataset:
1. Data Review and Cleaning
The study team will conduct a final review of all entered data to identify and resolve any 
discrepancies, missing fields, or formatting issues. This process will include: 
o Verification of subject identifiers and completeness of required fields 
 
o Validation of data ranges and consistency across entries 
 
o Review of open-text responses for completeness and clarity 
 
2. Finalization of Dataset 
 Once data cleaning is complete, a final dataset will be generated. A member of the study team 
not involved in the data entry process will independently verify the dataset against source entries 
to confirm its accuracy and completeness. 
 
3. 
 
 After verification, the database will be considered locked. This status will be documented in a 
 
o 
 
 
o Only read-only access will be maintained for auditing and analysis purposes 
 

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4. Archiving and Version Control
The locked dataset will be archived and version-controlled, with backup copies stored securely in 
Computer Security, and SOP210, Privacy). This version will be used for all statistical and 
qualitative analyses included in final reports and regulatory submissions.
These procedures ensure the reproducibility and transparency of study findings and align with good 
clinical practice (GCP) and ISO 14155:2020 guidelines for clinical investigations of medical devices.
f) Procedures for data retention. 
The principal investigator will maintain all essential study documents and source documents 
which support the data collected on the study subjects according to local regulations at the end 
of the study. The investigator is responsible for making sure these essential documents are not 
accidentally damaged or destroyed.  
At the end of study, routine close-out activities will be conducted to make sure records/data are 
accountability is accurate and complete. The principal investigator is also in charge of notifying in 
writing and providing appropriate reports to their IRB about the study completion. 
its HIPAA 
compliant data systems following completion of the study per its SOP200 Privacy, and SOP210, 
Computer Security procedures. This includes procedures and processes for  21CFR11 Electronic 
Records compliance, including system validation. 
g) Specified retention period. 
Per 
 
h) Other aspects of clinical quality assurance, as appropriate. 
one. 
A.9. 
Amendments to the CIP 
Description of the procedures to amend the CIP. 
If a revision to the CIP is deemed necessary by the principal investigator, it shall be reviewed and 
approved by 
 per the document control procedures (SOP020). 
A.10. Deviations from the CIP 
a) Statement specifying that the investigator is not allowed to deviate from the CIP, except as 
specified in 5.6.4 c). 
A protocol deviation happens when the investigator (intentionally/unintentionally) did not conduct 
the study according to the protocol and/or study agreement. Examples include late follow-up 

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visits, missed visits, required assessment not completed, non-adherence to Inclusion/Exclusion 
investigator is not allowed to deviate from study protocol except under emergency circumstances 
where necessary, to protect the life or physical well-being of a subject. These emergency 
later than 5 days after the emergency occurs. There will be unforeseen circumstances that are 
-up visit despite multiple 
reminders). Investigators are still required to report these as deviations. All deviations should be 
recorde
 
b) Procedures for recording, reporting, and analyzing CIP deviations.
All deviations from the approved Clinical Investigation Plan (CIP), including protocol-specified 
procedures, eligibility criteria, or data collection processes, will be documented, reviewed, and analyzed 
in accordance with ISO 14155:2020 guidelines and 
 Standard Operating Procedures (SOPs) for 
document and change control (SOP010, and SOP020). Any deviation from the CIP identified during the 
course of the study will be promptly recorded by the study team. Each deviation will be logged in a CIP 
Devia
A description of the deviation
 
 The date of occurrence
 
 The individual responsible
 The stakeholder(s) involved (provider, caregiver, or patient)
 The reason for the deviation (if known)
 Actions taken to address or mitigate the deviation
Minor deviations (e.g., missed data fields, slight delays in follow-up) will be documented but do not 
require immediate reporting unless they impact data integrity or participant safety. Deviations that 
impact participant safety, rights, or data integrity will be reported to the sponsor, and, if necessary, to the 
IRB in accordance with applicable regulations and timelines. Serious or repeated deviations will be 
escalated for sponsor review and potential corrective action.
All deviations will be reviewed at the conclusion of the study and analyzed for:
 Frequency and patterns (e.g., recurring issues at a particular stage of the study) 
 
 Impact on data quality, usability findings, or participant experience
 
 Root causes, including potential improvements to study tools or instructions 

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Findings from deviation analysis may inform updates to SOPs, user instructions, Qualtrics forms, or 
future clinical protocols. A summary of deviations and their resolution will be included in the Final 
Clinical Investigation Report. 
c) Notification requirements and time frames.
All required notifications will be submitted in accordance with applicable regulatory, ethical, and 
institutional guidelines, including those specified in ISO 14155:2020, the U.S. FDA regulations for Class I 
medical devices, and the policies of the reviewing Institutional Review Board (IRB). 
 also has 
standard procedures for reporting to meet regulatory requirements, per SOP120 (5.2).  
The Clinical Investigation Plan (CIP), informed consent materials, recruitment documents, and all 
supporting documents will be submitted to the IRB for initial review and approval prior to initiating any 
cruitment, enrollment, or data collection will begin until 
formal written approval is received. 
Any substantial modifications to the protocol, such as changes to the study design, recruitment strategy, 
informed consent documents, or study instruments, will be submitted to the IRB for approval prior to 
implementation, unless changes are required to el
-
substantive or administrative amendments (e.g., typographical corrections) will be reported as per IRB 
guidance. 
Although this study involves a minimal-risk Class I device, any unanticipated adverse device effects 
(UADEs) or unanticipated problems involving risks to participants or others will be reported to the IRB 
and sponsor within 10 business days of becoming aware of the issue, or in accordance with IRB-specific 
reporting timelines. Serious events will be reported immediately when necessary to protect participant 
safety. 
If required by the IRB, a continuing review submission will be provided at least 30 days prior to study 
expiration, including enrollment status, summary of adverse events (if any), and protocol deviations. 
Interim reports and updates may also be provided to stakeholders or sponsors as needed during the 
course of the investigation. A final report or closure notification will be submitted to the IRB and sponsor 
upon completion or early termination of the study. This will include a summary of the study conduct, 
data collected, participant outcomes, and any relevant findings or deviations. 
d) Corrective and preventive actions and principal investigator disqualification criteria.
assessment. If there is a suspected issue with the CIP surpassing the calculated risk threshold,  
procedure SOP080, CAPA Procedures.  
For final analysis, subjects who have major protocol deviations will not be included in the 
-protocol” population.

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A.11. Device Accountability
a) Description of the procedures for the accountability of investigational devices as specified 
in 7.9;
This study will use production equivalent/production candidate devices, which have been 
y a model number, lot 
number and date. A device accountability log will be maintained in accordance with the 
documenting dates of receipt, use, return of the device, the device lot number, and the subject 
number for whom the device was shared with. This process will be maintained until the 
conclusion of the study.  
b) Procedures and particular materials and instructions for the safe return of investigational 
devices, including those that are potentially hazardous. 
In the event of suspected or confirmed device deficiency, or adverse event, the device must be 
Procedures. 
Complaints will be logged per D-FRM-005, Complaint Form per SOP120. Coordinating with the 
A.12. Statements of Compliance 
a) Statement specifying that the clinical investigation shall be conducted in accordance with 
ethical principles that have their origin in the Declaration of Helsinki  
This clinical investigation shall be conducted in full accordance with the ethical principles 
outlined in the Declaration of Helsinki, including its most current amendments, which guide the 
protection of the rights, safety, and well-being of human participants involved in medical 
research. 
 
b) Statement specifying compliance with this document and any regional or national 
regulations, as appropriate.
This clinical investigation will be conducted in full compliance with the principles and requirements set 
forth in the ISO 14155:2020 – Clinical Investigation of Medical Devices for Human Subjects – Good 
Clinical Practice. This includes adherence to the requirements for protection of human subjects, 
scientific integrity, and accountability throughout all phases of the investigation. In addition, the study 
will comply with all applicable regional and national regulations, including: 
 U.S. Food and Drug Administration (FDA) regulations relevant to clinical investigations of medical 
devices under 21 CFR Part 812 (Investigational Device Exemptions), specifically under the 

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-
21 CFR Part 50 (Protection of Human Subjects) and 21 CFR Part 56 (Institutional Review Boards);
Health Insurance Portability and Accountability Act (HIPAA) privacy and data protection 
requirements for the collection and storage of personal health information; 
 Any additional guidance or requirements as set forth by the reviewing Institutional Review Board 
(IRB).
c) Statement specifying that the clinical investigation shall not begin until the required 
approval/favourable opinion from the EC and regulatory authorities have been obtained, if 
applicable 
The clinical investigation will not commence until all required approvals and favorable opinions 
have been obtained from the appropriate oversight bodies. Specifically, the study will not begin 
enrolling participants or initiating study procedures until approval has been granted by an 
Institutional Review Board (IRB) as required by 21 CFR Part 56 and ISO 14155.
If applicable, any additional regulatory approvals required by national or local authorities will also 
be obtained prior to initiating the investigation. Documentation of these approvals will be retained 
by the Sponsor and Principal Investigator and made available for audit or inspection upon 
request. 
This protocol, informed consent forms, recruitment materials, and data collection tools will all 
undergo IRB review to ensure compliance with ethical principles, protection of human subjects, 
and regulatory requirements. Only upon receipt of a written IRB approval or favorable opinion will 
participant recruitment and study activities begin. 
d) Statement specifying that any additional requirements imposed by the EC or regulatory 
authority shall be followed, if appropriate.  
This clinical investigation will be conducted in accordance with the approved Clinical 
Investigation Plan, applicable U.S. federal regulations, and the principles outlined in ISO 
14155:2020 for the ethical conduct of medical device investigations. The Sponsor and Principal 
Investigator acknowledge that any additional requirements imposed by the reviewing Institutional 
Review Board (IRB), or relevant regulatory authority will be followed, if appropriate. This includes, 
but is not limited to, additional safety monitoring, consent language modifications, reporting 
obligations, or oversight procedures deemed necessary to protect the rights, safety, and well-
being of participants. All amendments, protocol deviations, or other substantive changes will be 
submitted for review and approval in accordance with the policies of the IRB and applicable 

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regulatory bodies. The investigation team is committed to maintaining full compliance with all 
ethical and regulatory expectations throughout the duration of the study.
e) Statement specifying the type of insurance that shall be provided for subjects, if 
appropriate. 
Dr. Fairman maintains professional liability insurance the policy is included as an uploaded 
document with this proposed CIP.
umbrella policy (please see provided certificate).
f)
Statement addressing the financing of the clinical investigation including a description of the 
agreement between the sponsor and investigation sites and where applicable with the 
investigators if not addressed in a separate agreement.  
including investigator compensation, participant reimbursement, device provisioning, software licensing 
(e.g., for Qualtrics), and any administrative or data management expenses incurred during the conduct 
of the investigation.
The agreement between the sponsor and the primary investigation site—
—outlines 
responsibilities for study oversight, subject recruitment, data collection, device training and support, 
and regulatory compliance. Because the investigation is conducted through a single-site model with 
 
The sponsor has also entered into a formal agreement with the Principal Investigator (Dr. Andrea 
Fairman) to lead and manage the study in accordance with Good Clinical Practice (GCP), ISO 
14155:2020, and all applicable institutional and regulatory requirements. Dr. Fairman is compensated 
for her role in the design, implementation, coordination, and oversight of the investigation. This financial 
relationship is fully disclosed and managed under an institutional Conflict of Interest (COI) Management 
Plan. 
There are no financial arrangements in place that would incentivize outcomes or participant enrollment. 
The financing supports scientific and operational execution only and does not influence data 
interpretation or reporting. All deliverables and reporting obligations have been outlined in the sponsor-
investigator agreement, including provisions for confidentiality, intellectual property, and publication 
rights. 
 
 

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A.13. Informed Consent Process
a) Description of the general process for obtaining informed consent and incentives
Informed consent will be obtained from all participants—providers, caregivers, and patients—prior to 
enrollment and before any study-related procedures are initiated. The consent process will be 
conducted electronically via the HIPAA-compliant Qualtrics platform, allowing participants to review the 
consent materials at their own pace and submit their consent securely.
Participants will receive a detailed explanation of the study purpose, procedures, risks, benefits, 
voluntary nature of participation, confidentiality safeguards, and contact information for the study team 
and IRB. The electronic consent form will be tailored to each stakeholder group, with language 
opportunity to ask questions before agreeing to participate. For pediatric participants (ages 5–17), 
informed consent will be obtained from a parent or legal guardian, and age-appropriate assent will be 
obtained from the child when developmentally appropriate.
Incentives for participation will be provided in the form of a modest $25 electronic gift card, as IRB-
approved compensation for time and effort.  
b) Description of the informed consent process in circumstances where the subject is unable 
to give it; in case of emergency treatment.
This study is not designed to include individuals who are unable to provide informed consent, and no 
emergency treatment or urgent clinical interventions are part of the study protocol. Participants must 
have the cognitive and communicative ability to understand the study information or have a legally 
 
In cases where a subject is unable to consent due to age or disability: 
 A legally authorized representative (such as a parent, guardian, or healthcare proxy) will provide 
informed consent.
 
 If appropriate, assent from the participant will also be obtained in accordance with ethical 
guidelines and IRB requirements. 
be fully informed and will consent voluntarily before any data is collected or device use occurs. 
A.14. Adverse events, adverse device effects, and device deficiencies
a) Definitions of adverse events and adverse device effects.
An Adverse event (AE) is any untoward medical occurrence, unintended disease or injury or any 
untoward clinical signs (including any abnormal laboratory finding) in subjects, users, or other 
persons, whether or not related to the medical device. 

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A serious adverse event is any AE that:
•
• 
 
• 
A life-threatening illness or injury; or
• 
A permanent impairment of a body structure or a body function; or
• 
In-patient or prolonged hospitalization; or  
• 
Medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or body function; or 
• 
 
All adverse events that do not meet any of the above criteria for seriousness should be regarded 
as non-serious adverse events. 
condition worsens after enrollment. 
b) Definition of device deficiencies. 
A device deficiency is the inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. This includes malfunctions, user error and 
inadequate labelling. Alleged device deficiencies will be treated and handled as a complaint per 
SOP120.  
c) Definitions of serious adverse events including serious health threat and serious adverse 
device effects and, where appropriate, unanticipated serious adverse device effects.
Serious Adverse Device Effect (SADE) 
A serious adverse device effect is an ADE that can be attributed—wholly or in part—to the use of the 
investigational device or any procedure involved in the clinical investigation. This includes any event 
that meets the criteria for a serious adverse event and is reasonably related to the device, including:
 Device malfunction or failure, 
 
 Device misuse stemming from unclear instructions or design-related issues, 
 
 Unexpected physiological or psychological responses due to interaction with the device. 
Serious Health Threat 
A serious health threat refers to any situation in which the investigational device or study-related activity 
poses an immediate and significant risk to the health, safety, or welfare of a participant or others. This 
includes events requiring urgent action or modification of study procedures to mitigate risk.
Unanticipated Serious Adverse Device Effect (USADE) 

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An unanticipated serious adverse device effect is a SADE that was not previously identified in nature, 
severity, or frequency in the risk analysis or device documentation provided in the clinical investigation 
plan. USADEs must be reported promptly and may trigger changes to the risk management strategy, 
informed consent documentation, or continuation of the study.
Although Obi3 is a Class I device with minimal risk, the study team will monitor for any such events and 
report them in compliance with its SOP120, its associated D-FRM-005, Complaint Form and in 
accordance with ISO 14155, 21CFR812, and IRB requirements.
d) List of non-reportable adverse events, if applicable, including rationale.
Given that Obi Gen 3 is a Class I, non-invasive,  robotic feeding aid, there are no anticipated adverse 
events inherently associated with the device under intended use. Minor discomforts such as mild user 
frustration or meal spillage due to unfamiliarity with controls are not considered adverse events if they 
resolve quickly and do not require intervention. 
Rationale: These types of issues are consistent with expected variability during first-time use of assistive 
technology, especially in a non-clinical trial setting, and do not pose harm or risk to the participant. Such 
experiences will be captured in usability feedback but do not require AE reporting. 
e) Time period in which the principal investigator shall report all adverse events and device 
deficiencies to the sponsor and, where appropriate, to ECs and the regulatory authority. 
The principal investigator (PI) is responsible for reporting all adverse events (AEs), serious adverse events 
(SAEs), and device deficiencies to the sponsor within 24–48 hours of becoming aware of the event. 
f)
Details of the process for reporting adverse events (date of the adverse event, treatment, 
resolution, assessment of both the seriousness and the relationship to the investigational 
device and the related procedure).
All device deficiencies, whether or not they result in an adverse event, must be documented and 
reported to 
within 48 hours of discovery. Reporting should include:
Description of the deficiency or malfunction
Date of occurrence
Any corrective actions taken or recommended
deficiency was identified before or during use
The need to capture AEs is not dependent upon whether the clinical event is associated with the use of 
the study device or study procedure. 
Complaints regarding the device, including notice of an adverse event, or adverse device effect will be 
processed in accordance with 
processes and timing for adverse event handling, documentation and reporting to regulatory authorities.

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complaints resulting from the study. Any complaints, including notification of adverse events, resulting 
from study devices will be promptly sent to Heather Keeton & PI Dr. Fairman. 
For the purposes of this study, all AEs/SAEs/SADEs/USADE, or Serious Health Threats (events) must be 
collected from enrollment (ICF signature) through study completion. The principal investigator is 
ultimately responsible for reporting such events to the IRB. 
 
 
 
 
-related, unlikely, possibly related, 
probably-related, or causal relationship. 
g) Details of the process for reporting device deficiencies. 
Device deficiencies, including handling of adverse events, and adverse device effects (including 
procedure, SOP120, including D-FRM-005, Complaint Form. Device deficiencies will be recorded using 
the Complaint form and reviewed by the quality and engineering teams for tracking and analysis.
Corrective/Preventive Action will occur in accordance with SOP080, CAPA procedures, and any advisory 
-Conformance procedures.   
h) List of foreseeable adverse events and anticipated adverse device effects, together with 
their likely incidence, mitigation, or treatment. 
There are no anticipated serious adverse events (SAEs) based on the device's classification and prior 
real-world use. The following are foreseeable but rare adverse device effects during use of the Obi Gen 3:
Frustration or anxiety related to unfamiliar technology or difficulty in control coordination
Meal spillage or choking risk due to poor positioning or inadequate supervision in certain user
These events are considered low risk, especially when users are screened appropriately and receive 
training. Mitigation strategies include:
Device orientation and training prior to use
Provider oversight during setup and monitoring
Encouragement of caregiver presence during early use

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i)
Emergency contact details for reporting serious adverse events and serious adverse device 
effects. 
See sponsor contact information, A.1.3. 
j)
Information regarding the DMC, if established.
Given the minimal risk nature of this study and the non-interventional design, a formal Data 
Monitoring Committee (DMC) has not been established. All safety oversight will be managed 
internally by the Principal Investigator in collaboration with the sponsor. Any unexpected safety 
issues or emerging risks will trigger an ad hoc safety review, and the IRB will be informed 
accordingly.
A.15. Vulnerable Population (if applicable)
a) Description of the vulnerable population to be included in the clinical investigation.
This clinical investigation includes participation by children aged 5 years and older who require assistive 
technology for self-feeding. Children are considered a vulnerable population under federal and 
international research guidelines due to their limited legal capacity to provide informed consent and 
their potential dependence on caregivers and authority figures. Additionally, the study may include 
adults with disabilities, another potentially vulnerable group, particularly if cognitive or communication 
challenges are present.
b) Description of the screening process to identify and protect the vulnerable population.
Pre-screening will be conducted by qualified clinical staff in accordance with SOP220, which 
includes assessment of developmental, cognitive, and physical ability to participate meaningfully 
in the usability trial. Only individuals who demonstrate the ability to interact with the Obi Gen 3 
device with or without assistance and are capable of participating in basic study activities (e.g., 
completing feeding tasks, expressing feedback with support) will be included. For all participants, 
providers will verify that participation is voluntary and appropriate given the individual's medical, 
cognitive, and psychosocial context. Caregivers and/or legal guardians will be involved in the 
initial screening and enrollment decision.
c) Description of the specific informed consent process. 
The informed consent process for this study will be conducted in compliance with applicable ethical 
guidelines, including ISO 14155, the Declaration of Helsinki, and U.S. federal regulations (21 CFR Part 50 
and 45 CFR 46). The process is designed to ensure that all prospective participants—including patients, 
caregivers, and providers—are fully informed about the purpose, procedures, risks, benefits, and 
voluntary nature of the study prior to participation. All eligible participants will receive an IRB-approved 
informed consent form (ICF) appropriate to their role in the study (e.g., provider, caregiver, or patient). 
The consent process will occur electronically using the Qualtrics platform, which is configured to ensure 
secure delivery and storage of consent records in a HIPAA-compliant environment. Participants will be 

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provided with sufficient time to read the consent form, ask questions, and make an informed decision. 
For pediatric participants, age-appropriate assent will also be obtained, along with consent from a 
parent or legal guardian.
The process includes:
 Electronic delivery of consent forms via email link (Qualtrics) 
 Participant review and acknowledgment of understanding 
 Entry of electronic signature and date
 Secure, time-stamped storage of signed consent documents 
Informed consent must be completed before any study-related activities occur. The study team will 
coercion or undue influence will be used, and participants may withdraw at any time without penalty. 
Any updates to the consent process, form content, or electronic platform will be submitted for IRB 
review and approval prior to implementation.
d) Description of the EC's specific responsibility.
considerations or concerns. 
e) Description of what medical care, if any, will be provided for subjects after the clinical 
investigation has been completed. 
 
A.16. Suspension or premature termination of the Clinical Investigation 
a) Criteria and arrangements for suspension or premature termination of the whole clinical 
investigation or of the clinical investigation in one or more investigation sites. 
site/institution at any time, upon giving written notice. This may be based on the following reasons (but is 
not limited to): 
• 
The site/institution has not complied with the protocol, study agreement, requirements of the IRB 
or repeated failure to complete study assessments.  
• 
Failure to report safety, device deficiencies/malfunctions within 2 business days of awareness. 
• 
Repeated protocol violation 

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•
of site/institution suspension. A suspended site/institution may not enroll or offer Obi without sufficient 
tive and corrective actions have been implemented to resolve 
the root-
writing. Approval of IRB may be required, where applicable. 
b) Criteria for access to and breaking the blinding/masking code in the case of suspension or 
premature termination of the clinical investigation, if the clinical investigation involves a 
blinding/masking technique. 
Blinding is not part of the study design.  
c) Requirements for subject follow-up and continued care. 
In the instance of a study termination, any reportable safety concerns should be reported and recorded 
A.17. Publication Policy
a) Statement that the clinical investigation will be registered in a publicly accessible database 
(see 5.4). 
In accordance with ISO 14155:2020 Section 5.4 and ethical principles for transparency in clinical 
research, this clinical investigation will be registered in a publicly accessible database prior to the 
enrollment of the first participant. Registration will include key protocol details such as the study title, 
objectives, design, inclusion/exclusion criteria, and primary endpoints. The registry platform selected 
will meet international standards for public accessibility and transparency.
b) Statement indicating that the results of the clinical investigation will be made publicly 
available.
Furthermore, the results of this clinical investigation will be made publicly available following study 
completion and data analysis. Study findings will be disseminated in one or more of the following 
formats:
Submission to a peer-reviewed scientific journal,
Presentation at a scientific or professional conference,
Summary of findings posted to the same publicly accessible trial registry.
disclosure of any financial relationships or conflicts of interest, including that of the Principal 
Investigator.

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This publication policy aligns with ethical guidelines and regulatory expectations for openness in clinical 
research and reinforces the commitment of the sponsor and investigators to contribute to the scientific 
community and broader assistive technology field.
c) Statement indicating the conditions and timeframes under which the results of the clinical 
investigation will be offered for publication including the role of the sponsor and criteria for 
authorship. 
Any participating investigator wishing to publish data from this study (poster, abstracts, articles, etc.) 
ubmission to publication. 
A.18. Bibliography 
measurement of assistive technology usability. Disability and Rehabilitation: Assistive Technology, 2(4), 
235–248. https://doi.org/10.1080/17483100701343665
Cook, A. M., & Hussey, S. M. (2002). Assistive technologies: Principles and practice (2nd ed.). Mosby. 
Obi: Adaptive eating device for individuals with upper extremity limitations. Obi.
https://meetobi.com 
Food and Drug Administration. (2016). Applying human factors and usability engineering to medical 
devices: Guidance for industry and Food and Drug Administration staff. U.S. Department of Health and 
Human Services. https://www.fda.gov/media/80481/download
assessment process. Technology and Disability,14(3):125-131. doi:10.3233/TAD-2002-14308
administrative properties of measures used in assistive technology device outcomes research. Assistive 
Technology, 17(1), 7–22. 
International Journal of 
Human–Computer Interaction, 34
–590. 
Scherer, M. J., & Glueckauf, R. (2005). Assessing the benefits of assistive technologies for activities and 
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Organization, 2001. R2018.   
 
 
 

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Appendix B: Other Supporting Documentation
Research Study Required Documentation
PI Insurance Certificate
CITI Cert, 62378273 (Andrea Fairman)
CITI Cert, 50766681 (Andrea Fairman)
CITI Cert, 33760261 (Andrea Fairman)
CITI Cert, 50766679 (Andrea Fairman)
CITI Cert, 27227298 (Andrea Fairman)
CITI Cert, 47659142 (Andrea Fairman)
CITI Cert, 62122050 (Andrea Fairman)
CITI Cert, 68267401 (Heather Keeton)
CITI Cert, 68267399 (Heather Keeton)
CITI Cert, 68267400 (Heather Keeton)
CITI Cert, 64948276 (Ryan Osal)
CITI Cert, 66280848 (Ryan Osal)