A Prospective Clinical Investigation to Assess the Diagnostic Precision of the AI Tool Dermalyzer to Identify Malignant Melanomas in Subjects Seeking Primary Care for Melanoma-suspected Cutaneous Lesions
Conditions: Malignant Melanoma
Sponsor: Linkoeping University

 
 
 
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Clinical Investigational Plan  
 
 
Investigational Medical Device  
Dermalyzer 
 
Investigation code 
AI-DSMM  
 
CIP Version 
3.0 
 
Date 
CIV-ID 
21Mar2022 
CIV-21-12-038346 
TITLE OF THE CLINICAL INVESTIGATION 
A prospective clinical investigation to assess the diagnostic precision of the AI tool Dermalyzer to 
identify malignant melanomas in subjects seeking primary care for melanoma-suspected cutaneous 
lesions 
 
 
 
 Investigation Design * 
 
 
A pre-market, prospective, confirmatory, first in clinical setting, pivotal multi-centre, non-
interventional clinical investigation to evaluate the clinical safety, performance and benefit of 
Dermalyzer in patients with cutaneous lesions where malignant melanoma cannot be ruled out. 
 Indication studied* 
 
 
Malignant Melanoma  
 
 Investigational Medical Device  
 
 
Dermalyzer 
 Device classification 
 
 
II b 
 

 
 
 
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 Comparator product  
 
 
Not applicable 
 
 Duration of intervention 
 
Feb2021- 
Sep2022 
Sponsor signatory 
Region Östergötland, Centre for Primary Care,  
Hus 511-001, 581 85, Linköping, 
+46 (0)708-10 61 76/magnus.falk@liu.se 
 
 
Coordinating/Principal 
Investigator  
Magnus Falk/MD, assoc.professor/ 
Region Östergötland/Centre for Primary Care/ 
Linköping University, HMV/PRNV, Hus 511-001,  
Campus US, 581 85, Linköping, 
+46 (0)708-10 61 76/magnus.falk@liu.se 
 
 
 
The Karolinska Institutet (KI) and Region Östergötland (RÖ) share the sponsor responsibilities for the 
clinical investigation and collaborate with each other to conduct the clinical investigation. For the 
submission the Region Östergötland and Magnus Falk will be listed as the sponsor and National 
Coordinating Investigator (NCI). Magnus Falk and Panos Papachristou are both the Principal 
Investigators (PI) for each region and the 30 sites listed under them in their and adjacent regions. A 
list of investigators and staff at each site will be archived in the files at the Sponsor and at the site.                                    
 
* if not apparent from the title 
  
 
 

 
 
 
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The following amendments have been made to the Final CIP Version 1.0; 2021-12-23 
Amendment No. 
Date of Amendment  
Revised CIP Version  
1.0 
09Feb2022 
2.0 updates made based on 
comments from the Competent 
Authority  
2.0 
21Mar2022 
3.0 updates made to the version 
number of Dermalyzer and update to 
the dermatoscopes to use 
 

 
 
 
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2 
TABLE OF CONTENTS 
2 
33
 
84
 
125
 
145.1
 
145.2
 
145.3
 
145.4
 
155.5
 
165.5.1 
Risks/benefit associated with participation in the clinical 
investigation 
15 
5.5.2 
Contraindications 
15 
5.5.3 
Risk mitigation 
15 
5.5.4 
Residual risks 
15 
5.5.5 
Risk-to-benefit rationale 
15 
6 
177
 
197.1
 
197.2
 
207.3 
Fel! Bokmärket är inte 
definierat.7.4
 
217.5
 
218
 
218.1
 
218.1.1 
Primary 
endpoint 
19 
8.2 
228.2.1 
Secondary 
endpoints 
19 
9 
229.1
 
229.2
 
269.3
 
269.3.1
 
Recruitment 
22 

 
 
 
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9.3.2 
Number of subjects 
22 
9.3.3 
Screening and enrolment log 
22 
9.3.4 
Inclusion criteria 
22 
9.3.5 
Exclusion criteria 
22 
9.3.6 
Restrictions 
23 
9.3.7 
Criteria and procedures for subject withdrawal 
23 
9.4 
289.4.1 
General 
description 
23 
9.4.2 
Intended use 
23 
9.4.3 
IMD classification 
23 
9.4.4 
Manufacturer details 
24 
9.4.5 
Summary description of the IMD 
24 
9.4.6 
Intervention procedure 
24 
9.4.7 
Packaging, labelling and storage of the Investigational Medical Device 
24 
9.4.8 
Possible interactions with concomitant medical therapies 
24 
9.4.9 
Compliance with IMD usage 
24 
9.4.10 Accountability/traceability of the Investigational Medical Device 
24 
9.4.11 Method of assigning subjects to treatment groups 
24 
9.4.12 Blinding 
24 
9.4.13 Emergency decoding of blinded treatment 
25 
9.4.14 Continuation of intervention with the Investigational Medical Device 
25 
9.5 
319.5.1 
Demographics and other baseline 
characteristics 
25 
9.5.1.1 
Informed consent 
25 
9.5.1.2 
Demographic information 
25 
9.5.1.3 
Medical history 
25 

 
 
 
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9.5.1.4 
Prior and concomitant therapies 
25 
9.5.2 
Clinical performance assessments 
25 
9.5.2.1 
Assessment 1 
25 
9.5.3 
Laboratory assessments 
25 
9.5.4 
Clinical safety assessments 
26 
9.5.4.1 
Assessment 1 
26 
9.5.4.2 
Assessment 2 
26 
9.5.5 
Adverse Events and Device Deficiencies 
26 
9.5.5.1 
Coding of AEs 
26 
9.6 
Fel! Bokmärket är inte definierat.9.7
 
359.7.1 
CIP 
adherence 
27 
9.7.2 
Monitoring 
27 
9.7.3 
Audits and inspections 
28 
9.7.4 
Case Report Forms 
28 
9.7.5 
Source Data 
28 
9.7.6 
Training of investigation staff 
28 
9.8 
379.8.1
 
General 
29 
9.8.2 
Demographics and other baseline characteristics 
29 
9.8.3 
Analysis of clinical performance 
29 
9.8.3.1 389.8.3.2 
Fel! Bokmärket är inte 
definierat.9.8.4 
Analysis of 
safety 29 
9.8.4.1 
389.8.4.2 
Fel! Bokmärket är inte 
definierat.9.8.4.3 
Adverse Events (AEs) and device 
deficiencies 
30 

 
 
 
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9.8.5 
Statistical/analytical issues 
30 
9.8.6 
Analysis data sets 
30 
9.8.7 
Determination of sample size 
30 
9.9 
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3 
SYNOPSIS 
Title of the clinical investigation 
A prospective clinical investigation to assess the diagnostic precision of the artificial intelligence  (AI) 
tool Dermalyzer to identify malignant melanomas in subjects seeking primary care for melanoma-
suspected cutaneous lesions 
Investigation code 
AI-DSMM  
Investigational Medical Device  
Dermalyzer 
IMD classification 
IIb 
Intended use 
Dermalyzer is a device intended to be used as a decision support system for assessing cutaneous 
lesions suspected of being melanomas. The input from the device is not intended to be used as the 
sole source of information for diagnosis. The device should be used in combination with a medical 
professional assessment of the suspected lesion. Intended to be used by medical professionals. The 
service does not provide any other diagnosis. 
Coordinating/Principal Investigator  
Magnus Falk, MD, assoc.professor, Region Östergötland 
Time period for the clinical investigation 
Estimated date of first subject enrolled: Q1 2022 
Estimated date of last subject completed: Q3 2022 
Design of the clinical investigation 
This will be a pre-market, prospective, confirmatory, first in clinical setting, pivotal multi-centre, non-
interventional clinical investigation to evaluate the clinical safety, performance and benefit of 
Dermalyzer in patients with cutaneous lesions where malignant melanoma (MM) cannot be ruled 
out. 
Objectives and endpoints 
Primary objective 

 
 
 
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The primary objective of the investigation is to determine the diagnostic precision of the device; to 
answer at which level the AI tool Dermalyzer can identify malignant melanomas among cutaneous 
lesions that are assessed in clinical use due to any degree of malignancy suspicion. 
Primary endpoint 
The primary endpoint will be measured as the true proportion; by testing if the device based on AI 
gives correct results as compared with the result of the lesion analysis (the final classification by 
histopathology (PAD) in at least a certain proportion (π) of the analyses. 
Secondary objectives  
As secondary objectives a number of analyses will be done. 
To evaluate usability and applicability in clinical praxis of Dermalyzer by users (medical 
professionals)  
To gain an increased knowledge and understanding of how digital tools enhanced co-artificial 
intelligence can assist physicians with the right support for an earlier diagnosis of malignant 
melanoma. 
Secondary endpoints 
User questions including System Usability Scale to evaluate the usability and applicability in clinical 
praxis. 
 
Exploratory objective 
To explore health economic aspects of improved diagnosis support 
Exploratory endpoints 
Collecting health economic related information by survey to participating sites 
Number of subjects planned 
The estimated number of lesions to be recruited is approximately 500 in order to evaluate 239 
eligible lesions, based on power/sample size calculation. 
Diagnosis and main eligibility criteria 
Inclusion criteria: 

 
 
 
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1. Patients ≥18 years  
2. Patients attending a primary care facility with at least 1 suspicious skin lesion where MM 
cannot be ruled out.  
3. Willingness and ability to provide informed consent. 
 
Exclusion criteria: 
1. Cutaneous lesions that are considered as benign by the investigator and thus not subject for 
further clinical investigation 
2. Cutaneous lesions in areas that are not suitable for dermoscopy imaging 
3. Cutaneous lesions in areas with any form of scarring of tissue due to injury 
4. Damaged or injured non intact skin where the cutaneous lesion is located 
5. Individuals with skin type V and VI according to the Fitzpatrick scale (darker brown or black 
coloured skin) 
6. Cutaneous lesions in areas covered by tattoos 
7. Cutaneous lesions in abundantly hairy skin areas (provided the the area cannot be shaved 
freely from the hair to allow clear view for the dermatoscope) 
8. Images where the entire lesion is not inside the photo 
9. Images that are out of focus  
Methodology 
The subjects will be included from around 30 primary care centres in Sweden. If the subject’s lesion(s) 
is suspected of melanoma or melanoma cannot be ruled out, the subject is asked to participate in the 
investigation.  
The investigator examines the subject’s lesion(s) and makes the clinical assessment of the subject 
lesion(s) based on established clinical decision algorithms (such as "Chaos & clues", "3- or 7-point 
checklist", or the ABCDE concept) of whether there is a suspicion of MM, according to the usual 
clinical routine (also includes very low suspicion of MM but cannot be completely dismissed). The 
investigator takes dermoscopy images according to standard of care and archives the image(s) 
according to clinical routine. The investigator decides on action, based on his or her MM suspicion 
(excision at the primary care centre or referral for excision or referral to a dermatologist for further 

 
 
 
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assessment). If the subject has agreed to participate in the investigation, the investigator indicates in 
the CRF the clinical suspicion level of MM, and decided action. 
The investigator takes images of the lesion(s) again, this time with a mobile phone, containing the 
IMD AI SW, connected to a dermatoscope, and follows the on-screen instructions. The image is 
processed by the AI SW and the results are visible on the screen within seconds. A unique auto 
generated code number is also presented. The code number is registered on the enrollment log and 
in the CRF. The investigator records how he considers that the degree of suspicion of MM (higher vs 
lower) would have been affected by the AI SW result if it had been the governing body for the 
treatment.  
When the subject has been fully examined and receives the final tumor diagnosis from the 
histopathology/PAD results (melanoma/non melanoma), the degree of agreement between the PAD 
and the outcome of the AI SW decision support is calculated with the Kappa-analysis and the 
diagnostic accuracy to be able to distinguish melanoma from non-melanoma in the form of sensitivity 
and specificity as well the positive and predictive value. The corresponding comparison is performed 
from the examining  investigators' estimated clinical degree of suspicion, as well as the diagnostic 
accuracy when both the PAD and the AI decision support are weighted together (i.e. in cases where 
the investigator and the decision support are in agreement in their assessment).  The clinical 
investigation will collect information from the users, how participating users (investigators at the site) 
experience the usability of the AI SW decision support and attaching applications, from short surveys 
including the validated System Usability Scale.         
Use the same overall description given in Section 9.1. 
Duration of exposure to the Investigational Medical Device 
The subjects will not be in any direct contact with IMD Dermalyzer.  
Duration of subjects’ involvement in the investigation 
The subjects will only perform 1 visit at a primary care centre to assess the cutaneous lesion(s). 
Clinical performance assessments  
The subject will be examined according to clinical routine. The cutaneous lesions where MM cannot 
be ruled out (study lesions) will be photographed with a digital dermatoscope. The digital image 
will then be able to be instantly uploaded to the study's AI enhanced web application 
(Dermalyzer), where the AI algorithm performs the image analysis within a few seconds. 

 
 
 
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Clinical safety assessments  
All considered reportable events in accordance with MDR, will be captured. The subject included in 
the investigation will follow the standard of care. The use of the AI will not influence the subject 
or the medical care of the subject. 
Statistical methods 
The sample size of at least eligible 239 lesions is calculated by an expected true proportion of 95% 
with 80% power. The estimated frequency of actual found malignant melanoma is 4.65% (or 12 MM 
out of 239 lesions).  
4 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
 
Abbreviation or term           Explanation 
AE 
Adverse Event 
ADE 
AI 
AIMT 
Adverse Device Effect 
Artificial Intelligence 
AI Medical Technology AIM AB 
ASADE 
Anticipated Serious Adverse Device Effect 
CIP 
Clinical Investigational Plan 
CRF 
DD 
Case Report Form 
Device Deficiency 
EEA 
European Economic Area  
FAS 
Full Analysis Set 
ICF 
Informed Consent Form 

 
 
 
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IEC 
Independent Ethics Committee 
IFU 
Instructions for use 
GCP 
Good Clinical Practice 
IMD 
Investigational Medical Device 
MM 
Malignant Melanoma 
MDSW 
Medical Device Software 
N/A 
Not applicable 
PAD 
Pathological Anatomical Diagnosis 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect 
SD 
Standard Deviation 
SOP 
TMF 
Standard Operating Procedure 
Trial Master File 
USADE 
Unanticipated Serious Adverse Device Effect 
 
 
 
 
Enrolled subject 
Subject who has signed the Informed Consent Form (ICF) 
Screen failure 
Enrolled subject not included  
Included subject 
Subject fulfilling the eligibility criteria 
Withdrawn subject 
Subject included but not completed 

 
 
 
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Completed subject 
Subject completed the investigational period, including follow-up 
5 
ETHICAL AND REGULATORY REQUIREMENTS 
5.1 
Ethical and regulatory review 
Necessary approvals of the Clinical Investigational Plan (CIP), the subject Information sheet and 
Informed Consent Form (ICF) must be obtained before enrolment of any subject into the 
investigation. The written approvals, including an identification of the investigation and the date of 
review, will be filed in the Sponsor File and at the Investigation Site File.  
It is the responsibility of the Sponsor to keep the IEC and Competent Authority informed of Serious 
Adverse Events (SAEs) or device deficiencies that could have led to a SAE, any substantial 
amendments to the CIP and any safety updates/reports during the investigational period, according 
to local requirements.  
All correspondence with the IEC and Competent Authority will be filed both in the Sponsor Trial 
Master File (TMF). 
5.2 
Ethical conduct of the investigation 
The investigation will be performed in accordance with the recommendations guiding physicians in 
biomedical research involving human subjects that were adopted in 1964 by the 18th World Medical 
Assembly, in Helsinki, Finland, with later revisions and ISO 14155:2020. 
The Declaration of Helsinki is included as Appendix 13.2 to the CIP. 
5.3 
Subject information and consent 
It is the responsibility of the Investigator to give each potential investigational subject, adequate 
verbal and written information regarding the objectives and the procedures of the investigation as 
well as any risks or inconvenience involved before including the subject. The subject must be 
informed about the right to withdraw from the investigation at any time. The subject should be 
allowed sufficient time for consideration of the proposal.  
Furthermore, it is the responsibility of the Investigator to obtain signed informed consent from all 
subjects before including them in the investigation. The ICF must be signed and personally dated by 

 
 
 
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the subject and by the Investigator before any investigation-specific procedures are performed, 
including screening procedures. A copy of the Subject Information and the signed ICF will be 
provided to the subject. 
Documentation of the discussion and the date of informed consent must be recorded in the source 
documentation and in the Case Report Form (CRF). The signed Subject Information sheet and ICF 
should be filed by the Investigator for possible future audits and/or inspections.  
The final version of the Subject Information sheet and ICF are submitted to the IEC and concerned 
Competent Authority and must not be changed without permission from Sponsor, the Competent 
Authority and the local IEC. 
The subjects will be asked for participation in the clinical investigation when seeking care for 
suspicious cutaneous lesions at the primary care centre. The subject can also be identified if an 
investigator sees a suspicious lesion when examining the subject for another purpose.  If the 
subject’s lesion(s) is suspected of MM or MM cannot be ruled out the subject is asked to participate 
in the investigation.  The subject receives oral and written study information and will have time to 
read the information and ask any questions. If the subject voluntarily agrees to participate the 
consent form is signed before any investigation assessments are collected.  
5.4 
Subject data protection 
The ICF includes information that data generated during the investigation will be recorded, collected 
and processed and may be transferred to countries within the European Economic Area (EEA). In 
accordance with the General Data Protection Regulation 2016/679 (GDPR), the data will not identify 
any persons taking part in the investigation. 
The potential investigational subject should be informed that by signing the ICF he/she approves 
that authorized representatives from the Sponsor and sponsor representatives (i.e CRO), the IEC and 
the Competent Authorities, as applicable, have direct access to his/her medical records for 
verification of clinical investigational procedures. 
To ensure the confidentiality of the subjects in the clinical investigation each subject will receive a 
pseudonymised subject ID within the database. The subject identification list will be kept separately 
by the site in a secure manner. The Investigator must file a subject identification list, which includes 
sufficient information to link records, i.e. the CRF and clinical records. This list should be preserved 
for possible future inspections/audits but should not be made available to the Sponsor or sponsor 
representatives except for monitoring or auditing purposes.  

 
 
 
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All data going to and from Trial Online are secured using strong encryption. It is not possible to gain 
access to data being transmitted from the web browser. The databases comprising the system are 
located in a secure data centre with strong physical protection in place. Access to the servers is 
protected by using strong authentication (individual username and password combination as well as 
a one-time password). Data is backed up every 24 hours and all backup data is backed-up once every 
24 hours to a separate data centre facility. Access to infrastructure elements and backup copies is 
limited and controlled. User access will be checked and followed up on a regular basis during the 
investigation. 
5.5 
Risks and benefits of the Investigational Medical Device and clinical investigation 
5.5.1 
Risks/benefit associated with participation in the clinical investigation 
There are no foreseen risks to participate in the clinical investigation than those according to current 
standard of care for the target population. The IMD is a software and not in contact with or used by 
the subjects. The subjects will receive the same standard of care as they would if they were not 
participating in the clinical investigation. The outcome of the IMD AI will not influence the treatment 
of the subject. The IMD log-in screen is marked “use only for clinical investigation” to ensure it will 
only be used by investigators participating in the clinical investigation.  
5.5.2 
Contraindications  
It is not recommended analyzing lesions in the following situations. 
● Cutaneous lesions masked by an excessive amount of hair. 
● Any form of body modification by injecting ink, dyes, and/or pigments covering or 
surrounding skin lesions. 
● Any form of scarring of tissue due to injury. 
● Damaged or injured non-intact skin with lesions. 
● Cutaneous lesions on non-human subjects. 
 
5.5.3 
Risk-to-benefit rationale 
There are no additional risks for participating subjects as they will receive the standard of care as per 
routine at the investigations site. The only added procedure is an additional photo taken for the 
evaluation by the AI. The healthcare personnel in the investigation will have to perform additional 

 
 
 
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documentation and answer if the device may be of benefit if applied as diagnostic support after CE-
mark. Thus, there are no or low risks and possible benefits, thus the ratio is favourable. 
6 
INVESTIGATOR(S) AND INVESTIGATION ADMINISTRATIVE STRUCTURE 
This clinical investigation,sponsored by Karolinska Institutet (KI) and Region Östergötland (RÖ) 
Centre for Primary Care, will be conducted at several primary care centres, see appendix 13.4 . 
Clinical monitoring and Data Management will be provided by Key2Compliance. Key members of the 
Sponsor, and Key2Compliance project teams and sub-contractors are presented below. 
 
 
Sponsor 
Principal Investigator & Sponsor’s Signatory 
 
Magnus Falk 
Phone: +46 (0)70 810 61 76 
E-mail: magnus.falk@liu.se 
 
 
Sponsor Medical Officer 
 
Panos Papachristou  
Phone: +46 (0)70 229 88 92 
E-mail: panos.papachristou@ki.se 
 
 
 
 
 
 
Investigational site(s) 
Magnus Falk and Panos Papachristou are the Principal 
Investigators (PIs) for all 30 sites in the clinical investigation. 
Magnus Falk is, in addition, the NCI. They are responsible PIs for 
Primary Care centres in their and adjacent regions. For site list 
see Appendix 13.4. A detailed description is listed in the 

 
 
 
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document 07e_Site structure, GCP Resources and PI 
oversight_2.0_ddJan2022. Magnus Falk and Panos Papachristou 
will delegate responsibilities to sub-investigator at each of the 
30 sites.  
 
 
 
 
CRO – Data Management and Clinical 
Monitoring  
Clinical Project Manager  
Name Johanna Fondell 
Phone: +46 (0)73 091 51 36 
E-mail: johanna.fondell@key2compliance.com 
 
Monitor 
Name Paméla Stenström 
Phone: +46 (0)73 023 70 12 
E-mail: pamela.stenstrom@key2compliance.com 
  
 
 
Statistician 
Name Mikael Åström 
Phone: +46 (0)76 139 22 22 
E-mail: astrom.mikael@telia.com 
 
 
 
 
 
Signatures required are provided in Appendix 13.1.

 
 
 
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7 
INTRODUCTION 
Dermalyzer is an Artificial Intelligence (AI) application (app) that allows medical professionals to take 
pictures of cutaneous lesions with the help of a smartphone camera. A dermatoscope is connected 
to the smartphone camera and is used to take the digital image of cutaneous lesions with suspicion 
of melanoma. Based on image processing algorithms, the app does a detailed analysis of the 
captured cutaneous lesion. Dermalyzer provides information for medical professionals as decision 
support when assessing skin lesions such as melanoma.  The input from the device is not intended to 
be used as sole information for diagnosis. The software application can be used on either a mobile or 
a computer. 
Dermalyzer is a Medical Device that is not CE-market yet, the plan is to collect clinical data in the 
planned Clinical Investigation. In the clinical investigation, the technically verified and validated 
MDSW version 0.0.2 dated 2022 will be applied. 
The aim of the current clinical investigation is to determine the diagnostic accuracy of the 
Dermalyzer device. This medical device investigation has been initiated by the investigators, thus the 
Sponsor and Investigator is the same under these circumstances.   
7.1 
Background 
Malignant melanoma is a type of tumor resulting from an uncontrolled proliferation of melanocytes 
(pigment-producing cells), a type of cell found in the mucous membranes, eyes, and innermost layers 
of tissue covering the brain and spinal cord1,2. Despite advances in both diagnosis and treatment of 
malignant melanoma, the disease is still a major challenge within healthcare1. The incidence of the 
disease among several fair-skinned populations has increased with as much as 4-6 percent yearly1,3 
and melanoma is one of the cancer types with the highest average years of life lost per death (15 
years), so-called AYLL4. Melanoma accounts for only 5 percent of cutaneous malignancies, but can be 
attributed to most skin cancer deaths1. 
During 2020 it was estimated that Europe had a total incidence of approximately 150,000 and the total 
number of deaths caused by melanoma was approximately 26,000. North America had a total 
incidence of approximately 105,000 and the total number of deaths caused by melanoma was 
approximately 8,500. Oceania had a total incidence of approximately 19,000 and the total number of 
deaths caused by melanoma was approximately 20005.  

 
 
 
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Primary care and general practitioners play a vital role in detecting patients with suspected skin lesions 
and thus in detecting melanoma at early stages6. Histopathology (or ‘Pathologic anatomic diagnosis’, 
PAD) is considered the gold standard in melanoma diagnosis. For histopathological diagnosis the 
suspected lesion is excised and inspected by a dermatopathologist, who can report on characteristics, 
such as melanoma subtype, tumor thickness and ulceration. If the malignancy is not detected at an 
early stage and is allowed to metastasize and spread outside its primary location, it is more challenging 
to treat and the chance of survival decreases1. If detected at an early stage, excision of the skin lesion 
is associated with a high chance of survival7. On the other hand, unnecessary excision of benign skin 
lesions are common and leads to increased morbidity as well as increased healthcare costs8. The direct 
and indirect healthcare and societal costs for diagnosing and treating malignant melanoma, as well as 
costs associated to melanoma deaths, are significant 1,8.  
Detection and treatment of melanoma in early stages takes up only a fraction of the resources needed 
to treat melanoma in later stages. Early detection can thus contribute to cost savings7. Innovative 
technological solutions used in secondary preventive strategies have the potential to reduce costs1,7. 
Although significant progress has been made in recent years, much more research and innovation are 
needed3. Given the severity of the disease, in terms of rising incidence and mortality rates and the 
associated costs, it is important to develop cost-effective methods to facilitate skin lesion 
examinations. Diagnosis of melanoma in early stages is in the best interest to patients, payers and the 
healthcare system7.  
Artificial intelligence (AI) has, in controlled experimental environments, shown promising results in 
diagnosing malignant melanoma9. Areas such as medical image analysis have almost completely 
shifted digital images10. In turn, and in conjunction with AI, enabling physicians to perform faster and 
more accurate image interpretation11. 
Technological advances have also made it possible to implement AI, with significant potential for 
improving healthcare systems and processes12,13. These technological advances have enabled 
opportunities for improving healthcare instruments such as diagnostic decision support systems 
(DDSS)14. Through decision support systems, AI can partially alleviate and overcome digitalization 
challenges in healthcare. 
7.2 
 Investigational Medical Device  
The Investigational Medical Device (IMD) is Dermalyzer,an Artificial Intelligence (AI) application (app) 
that allows medical professionals to take pictures of cutaneous lesions with the help of a 
smartphone camera. A dermatoscope is connected to the smartphone camera and is used to take 

 
 
 
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the digital image of cutaneous lesions with suspicion of melanoma. Based on image processing 
algorithms, the app does a detailed analysis of the captured cutaneous lesion. Dermalyzer provides 
information for medical professionals as decision support when assessing cutaneous lesions such as 
melanoma.  The input from the device is not intended to be used as sole information for diagnosis. 
The medical software (MDSW) application can be used on either a mobile or a computer. 
 A more detailed description is given in Section 9.4  
 
7.3 
Clinical experience 
The AI has been trained by batches of photos collected during clinical use of dermoscopes. Several 
experienced clinicians have been part of the device development. This is the first time the device is 
tested in clinical settings. 
7.4 
Rationale for the investigation  
There is a clear benefit at group level if the methodology can contribute to safer, more accurate and 
efficient diagnostic procedures of patients seeking primary care for skin lesions of concern, while 
there are, on the other hand, no significant risks associated with the study. Potentially fewer cases 
of unnecessarily excised benign skin lesions would contribute to improved access to care for those 
with malignant lesions, thereby also increasing the prerequisites for early cancer detection. Overall, 
the benefits of the study are clearly considered to outweigh the risk(s).  
8 
INVESTIGATIONAL OBJECTIVES AND ENDPOINTS 
8.1 
Primary objective 
The primary objective of the investigation is to determine the diagnostic precision of the device; to 
answer at which level the AI tool Dermalyzer can identify malignant melanomas among cutaneous 
lesions that are assessed in clinical use due to any degree of malignancy suspicion. 

 
 
 
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8.1.1 
Primary endpoint 
The primary endpoint will be measured as the true proportion; by testing if the device based on 
artificial intelligence (AI) gives correct results as compared with the result of the lesion analysis (the 
final classification by PAD) in at least a certain proportion (π) of the analyses. 
8.2 
Secondary objectives  
As secondary objectives a number of analyses will be done. 
To evaluate usability and applicability in clinical praxis of Dermalytics by users (medical 
professionals).  
To gain an increased knowledge and understanding of how digital tools enhanced co-artificial 
intelligence can assist physicians with the right support for an earlier diagnosis of malignant 
melanoma. 
8.2.1 
Secondary endpoints 
User questions including System Usability Scale to evaluate the usability and applicability in clinical 
praxis. 
8.3 
Exploratory objectives  
To explore health economic aspects of improved diagnosis support.  
8.3.1 
Exploratory endpoints 
Collecting health economic related information by survey to participating sites.  
9 
INVESTIGATIONAL PLAN 
9.1 
Overall investigational design and schedule of events 
The subjects will be included from primary care centres. If the subject’s lesion(s) is suspected of 
melanoma or melanoma cannot be ruled out the subject is asked to participate in the investigation. 
The investigator examines the subject's lesion(s) (with or without a dermatoscope) and may also 
take dermoscopy images according to standard of care. The investigator then makes his clinical 

 
 
 
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assessment of the subject lesion(s) based on established clinical decision algorithms (such as "Chaos 
and clues", "3- or 7-point checklist", or the ABCDE criteria) of whether there is a suspicion of 
melanoma, according to the usual clinical routine (also includes very low suspicion that cannot be 
completely dismissed). The investigator decides on action based on his or her MM suspicion 
(excision at the primary care centre or referral for excision or referral to a dermatologist for further 
assessment), see figure 1. 
If the subject has agreed to participate in the investigation, the investigator indicates in the eCRF his 
clinical suspicion level of MM and decided action. 
The investigator takes images of the lesion(s) again, this time with a mobile phone, containing the 
IMD AI SW, connected to a dermatoscope, and follows the on-screen instructions, see appendix 
13.3. The image is processed by the AI SW and the results are visible on the screen within seconds. A 
unique auto generated code number is also presented. The code number is registered on the 
enrollment log and in the eCRF. The investigator records how he considers that the degree of 
suspicion of MM (higher vs lower) would have been affected by the AI SW result if it had been the 
governing body for the treatment. When the PAD result is available the outcome is documented in 
the eCRF. 
Figure 1. Investigator workflow for assessing MM suspicion and action to be taken 

 
 
 
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Visits and assessments will be performed as described in Table 9.1. Each assessment is further 
described in Section 9.5. 
 
 

 
 
 
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Table 9.1   Schedule of events 
 
Baseline/ Visit 1 
Follow-up 1 
Follow-up 2 
 
Day 1 
Day 30(+/-30) 
After at least 
10 subjects 
Informed consent + photo 
consent 
x 
 
 
Inclusion/Exclusion criteria 
x 
 
 
Demographics (Age, melanoma 
history/family history, race)  
x 
 
 
Fitzpatrick skin type (exclude V-
VI 
x 
 
 
Lesion assessment (body area, 
number of lesions, size) 
x 
 
 
Clinical assessment  (naked-eye 
examination, with or without 
dermoscopy,) “Chaos&clues”, 
3-point checklist, ABCDE 
criteria 
x 
 
 
AI photo 
x 
 
 
Histopathology (PAD)  
 
x 
 
In theory if degree of suspicion 
affected by device 
x 
 
 
User questionnaire 
 
 
x¹ 
Health economic outcomes 
 
 
x² 
Adverse Event 
x 
x (from journal 
if relevant) 
 

 
 
 
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¹To be answered by Investigators at one occasion only 
²To be collected by each region's actual cost for PAD and excision or data collected via the KPP-database. 
 
Figure 2. Overview of workflow 
 
9.2 
Justification for the design of the clinical investigation 
The device has reached the development stage where a verification of its applicability in the clinical 
settings is warranted. The design of the investigation is that of a safe way to test the device in clinical 
use without changing the standard- of-care for the participating subjects, while collecting data on 
possible benefits of the use of the device. 
9.3 
Selection of investigational population  
9.3.1 
Recruitment 
Subjects having lesions where MM cannot be ruled out will be identified for inclusion in this CI. The 
subject visits the primary care clinic for examination of one or more skin lesions of concern, or the 
investigator detects a suspected skin lesion in connection with another cause of visitation.  

 
 
 
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9.3.2 
Number of subjects 
To reach the target of 239 eligible lesions with a PAD approximately 500 lesions will need to be 
included, that is up to 500 subjects.  The CI needs to be able to analyse 239 PAD verified lesions 
where at least 12 lesions need to be PAD positive responses (confirmed MM). In case, after 500 
subjects/lesions have been evaluated and the 12 positive PAD have not been obtained, further 
subject enrolment will continue until 12 positive PAD have been reached.  
9.3.3 
Screening and enrolment log 
Each clinic will keep a log of all subjects screened and included. The reason for screening failure 
should be stated for all subjects screened but not included. The reason for withdrawal should be 
stated for all subjects included but not completed. 
9.3.4 
Inclusion criteria 
For inclusion in the investigation, subjects must fulfil all the following criteria:  
1. Patients ≥18 years  
2. Patients attending a healthcare facility with at least 1 suspicious skin lesion where MM 
cannot be ruled out.  
3. Willingness and ability to provide informed consent.     
 
9.3.5 
Exclusion criteria 
Subjects must not enter the investigation if any of the following exclusion criteria are fulfilled: 
1. Cutaneous lesions that are considered as benign by the investigator and thus not subject for 
further clinical investigation 
2. Cutaneous lesions in areas that are not suitable for dermoscopic imaging 
3. Cutaneous lesions in areas with any form of scarring of tissue due to injury 
4. Damaged or injured non intact skin where the cutaneous lesion is located 
5. Individuals with skin type V and VI according to the Fitzpatrick scale (darker brown or black 
coloured skin) 

 
 
 
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6. Cutaneous lesions in areas covered by tattoos 
7. Cutaneous lesions in abundantly hairy skin areas (provided the area cannot be shaved freely 
from the hair to allow clear view for the dermatoscope) 
8. Images where the entire lesion is not inside the photo 
9. Images that are out of focus  
 
9.3.6 
Criteria and procedures for subject withdrawal 
An investigational subject should be withdrawn from the intervention if, in the opinion of the 
Investigator, it is medically necessary, or if it is the expressed wish of the subject. In this CI the 
subjects only participate a short time at one visit however a subject can always at any time withdraw 
consent.  
9.4 
Investigational Medical Device description 
9.4.1 
 General description  
Dermalyzer is an image analysing software application functioning as decision support to healthcare 
professionals on assessing suspected cutaneous lesions for skin cancer. The device should be used in 
combination with a medical professional assessment of the suspected lesion. The software 
application uses a mobile camera to capture images of cutaneous lesions. 
9.4.2 
Intended use 
The device is intended to be used as a decision support system for assessing cutaneous lesions 
suspected of being melanomas. The input from the device is not intended to be used as the sole 
source of information for diagnosis. The device should be used in combination with a medical 
professional assessment of the suspected lesion. The service does not provide any other diagnostic 
use. 
9.4.3 
IMD classification 
Non CE marked Medical Device Software (MDSW) class IIb. 

 
 
 
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9.4.4 
Manufacturer details 
AI Medical Technology AIM AB 
Sturegatan 44 D 
114 36 Stockholm 
9.4.5 
Summary description of the IMD 
An overview picture of the IMD is given in Figure 3. 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 3    Overview of the Investigational Medical Device - Dermalyzer Clinical Decision Support 
System 
9.4.6 
Intervention procedure 
Dermalyzer shall be used by medical professionals in primary care settings. The software shall be 
used as a decision support system to assess cutaneous lesions on patients aged 18 or more having 
suspicious melanoma lesions.  

 
 
 
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Detailed Instructions for use (IFU) are included in Appendix 13.3. 
9.4.7 
Packaging, labelling and storage of the Investigational Medical Device 
For the clinical investigation, the application Dermalyzer from Google Play or App Store is already 
downloaded on a compatible Android or iOS mobile device. Operating system compatibility for iOS is 
13.0 and later and Android is Pie 9 (API Level 28) and later. Dermatoscopic adaptors will be used 
connected to the phone. The sites can have different types of smartphones and versions will be 
captured in the eCRF. The application Dermalyzer log-in screen is marked “Use only for Clinical 
Investigation”, see Figure 4.  
 
 
 
 
 
 
 
 
 
 
Figure 4.   Dermalyzer Log-in Screen 
 
9.4.8 
Compliance with IMD usage 
The IMD must be used according to the IFU, see Appendix 13.3. 
9.4.9 
Accountability/traceability of the Investigational Medical Device  
The accountability of the IMD will be documented both which mobile phones that will be provided 
to which site but also which version of the device that is applied. The sponsor-investigator or 
delegated personnel is responsible to ensure traceability. Each site will be provided with a phone 

 
 
 
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with a unique sim-card and each phone will have a unique IMEI number. The phones sent to each 
site will be controlled and locked to only allow certain functions, which means that full control, over 
all software installed on the phones in general and which version of the software that is installed on 
each device in particular, can be achieved. The dermatoscope model that will be used as 
attachments to the phones during the investigation is the DermLite D3 and Heine iC1/7.  
9.4.10 Blinding 
The Investigators will have to document their assessment of the included lesion(s) in the eCRF 
before taking the IMD image in order not to be influenced by the IMD result. When the outcome of 
the IMD AI result is available the Investigator will evaluate if his/her decision would have changed if 
taking the result of the AI into consideration.  
9.5 
Investigational assessments 
The investigational assessments are described in the sections below and the timing of these 
assessments is detailed in the schedule of events (Table 9.1, Section 9.1).   
9.5.1 
Demographics and other baseline characteristics 
9.5.1.1 
Informed consent 
Signed informed consent must be obtained before any screening procedures are initiated. The 
informed consent procedure is further described in Section 5.3. 
9.5.1.2 
Demographic information 
The following demographic data will be recorded: age, gender, Fitzpatrick skin type (I-IV),  ethnic 
origin. 
9.5.1.3 
Medical history  
Medical history relevant for the investigation, as judged by the Investigator, will be obtained, as skin 
cancer history.  
 

 
 
 
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9.5.2 
Clinical performance assessments  
9.5.2.1 
Assessment 1 
Dermoscopy image with mobile phone and attached dermatoscope 
9.5.2.2 
Assessment 2 
The method applied according to standard of care at each site (Chaos & clues", "3- or 7-point 
checklist", ABCDE concept or other) for the investigator to make his/hers clinical assessment of the 
subjects lesions to establish whether there is a suspension of MM will be documented in the CRF.  
9.5.3 
Laboratory assessments 
Histopathology results ( PAD)  from excised lesions according to standard routine. 
9.5.4 
Clinical safety assessments 
9.5.4.1 
Assessment 1 
All considered reportable events in accordance with MDR, will be captured. See section below for 
the Serious Adverse Event (SAE) and Device Deficiency (DD). 
9.5.5 
Health economic  assessments 
9.5.5.1 
Assessment 1 
A survey will be collecting health economic related information to participating sites 
9.5.6 
Safety reporting, Adverse Events and Device Deficiencies 
The reporting modality for the current clinical investigation is “Pre-market clinical investigations 
covered by Articles 62 and 74(2) of the MDR conducted with:Non-CE marked device”. 
 
Adverse Event (AE) and Serious Adverse Event (SAE) 

 
 
 
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▪ 
AE - Any untoward medical occurrence, unintended disease or injury or any untoward 
clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in 
the context of a clinical investigation, whether or not related to the investigational device 
▪ 
SAE- Any adverse event that led to any of the following:  
a) death,  
b) serious deterioration in the health of the subject, that resulted in any of the following:  
i. 
life-threatening illness or injury,  
ii. 
permanent impairment of a body structure or a body function,  
iii. 
hospitalisation or prolongation of patient hospitalisation,  
iv. 
medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function,  
v. 
chronic disease,  
c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect.  
 
Device Deficiency (DD) 
Is defined as any inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, usability, safety or performance. 
Device deficiencies include malfunctions, use errors, and inadequacy in the information supplied by 
the manufacturer including labelling. 
 
Considered reportable events in accordance with MDR 
▪ 
any SAE that has a causal relationship with the investigational device, the comparator or the 
investigation procedure or where such causal relationship is reasonably possible; 
▪ 
any device deficiency that might have led to SAE if appropriate action had not been taken, 
intervention had not occurred, or circumstances had been less fortunate 
▪ 
any new findings in relation to any event referred to in points a) and b) 
 
Reporting requirements 
Reportable events will be reported by the KI/RÖ or AIMT (sponsor-investigator) of the clinical 
investigation.  
 

 
 
 
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Reporting timelines 
a) All reportable events which indicate an imminent risk of death, serious injury, or serious 
illness and that requires prompt remedial action for other patients/subjects, users or other 
persons or a new finding to it - Immediately, but not later than 2 calendar days after 
sponsor-investigator are made aware of the new event 
b) Any other reportable events or a new finding/update to it - not later than 7 calendar days 
after sponsor-investigator are made aware of the new event 
 
In the event of a reportable event, it should be documented in the subject's medical record, 
documented in the eCRF as well completion of the Clinical Investigation Summary Safety Report 
Form (appendix 13.5). The Clinical Investigation Summary Safety Report Form needs to be filled 
in/updated for each reportable event or for new findings/updates to already reported events.  
For the investigational site and during the clinical investigation, the investigator needs to report the 
reportable event to the sponsor immediately, but not later than 3 calendar days after investigation 
site study personnel’s awareness of the event.  
 
Causality assessment 
The relationship between the use of the medical device and the occurrence of each adverse event 
shall be assessed and categorized. Each SAE will be classified according to four different levels of 
causality:  
1. Not related  
2. Possible  
3. Probable  
4. Causal relationship 
 
Only causality level 1 (i.e. “not related”) is excluded from reporting. If higher causality level than "not 
related", the event should be reported. Any device deficiency that might have led to a SAE should be 
reported.  
 
Reporting form (Appendix 13.5_Clinical Investigation Summary Safety Report Form_1.0_20Jan2022 
▪ 
Form is study specific and covers only the given clinical investigation  
▪ 
The template form contains inserted filters and functionality to facilitate use of preferred 
terminology in the reporting. These are important for the analysis and should be maintained 

 
 
 
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▪ 
The table gives a cumulative overview of the reportable events per clinical investigation and 
will be updated and transmitted to participating NCAs each time a new reportable event or a 
new finding to an already reported event is to be reported.  
9.6 
Data quality assurance 
This clinical investigation will be conducted in compliance with the CIP, relevant Standard Operating 
Procedures (SOPs), the principles of the European Standard EN ISO 14155 Clinical Investigation of 
Medical Devices for Human Subjects – Good Clinical Practice (GCP), MDR (EU) 2017/745 and any 
other applicable regulatory requirements. 
9.6.1 
CIP adherence 
The Principal Investigator is not allowed to deviate from the CIP.   
The Sponsor-investigator is responsible for documenting and analysing any deviations and assessing 
their significance. Corrective action will be implemented to avoid repeated deviations, which may 
include suspending the clinical investigation and/or amending the CIP. 
9.6.2 
Monitoring  
The monitoring will be done according to the Monitoring Plan with the purpose to verify that all 
aspects of the CIP are complied with and that the conduct of the investigation conforms to 
applicable regulatory requirements and established rules for Helsinki Declaration and 
GCP/ISO14155, to protect the rights, safety and well-being of the human subjects. 
Monitoring will be done as on-site or remote visits and during central monitoring. 
During the monitoring visit the monitor will verify the Informed Consent procedure, review CRFs and 
source data, check SW version for the IMD, reporting of DD, etc. The extent of SDV and the strategy 
for risk-based monitoring will be described in the Monitoring Plan.  
For the purpose of SDV, the Monitor must be given direct access to original clinical records according 
to the Source Data Agreement.  
9.6.3 
Audits and inspections 
Authorized representatives of Sponsor, or a Competent Authority may perform audits or inspections 
at the investigational site. The purpose of an audit or inspection is to systematically and 

 
 
 
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independently examine all investigation-related activities and documents, to determine whether 
these activities were conducted, and data were recorded, analysed, and accurately reported 
according to the CIP, EN ISO 14155 and any other applicable regulatory requirements.  
The site Investigators are required to inform the Sponsor-Investigator immediately of an inspection 
requested by a Competent Authority or IEC. 
9.6.4 
Case Report Forms  
Case Report Forms must be completed and signed by authorized personnel for each included 
subject.   
All data must be entered in English. The CRFs should always reflect the latest observations made 
during the subject’s participating in the investigation. Therefore, the CRFs should be completed as 
soon as possible during or after the subject’s visit.  
The Investigator must verify that all data entries in the CRFs are accurate and correct by signing the 
completed CRF. 
The completed CRFs should be made available for checking of completeness and accuracy by the 
Monitor as agreed in advance.  
9.6.5 
Source Data  
A separate source data document will be generated for the investigational site before start of 
enrolment, specifying the location of the source of derived information appearing in the CRF. This 
document must be signed by the Sponsor-Investigator and the Monitor to confirm agreement before 
the start of recruitment. 
The Investigator should guarantee access to source documents to the Monitor, Competent 
Authorities and the IECs, if required. 
9.6.6 
Training of investigation staff  
In connection to Site initiation visit, all sites will be trained on the ISO 14155 (GCP training) via a 
video, the sites will have time to ask questions during a Q&A. Before inclusion of the first 
investigational subject the Monitor/sponsor will perform an Initiation Visit at the investigational site, 
this may be done remotely, if applicable. The requirements of the CIP and related documents will be 
reviewed and discussed, and the investigational staff will be trained in any investigation specific 
procedures and system(s) utilised. A Site Initiation slide deck will be reviewed with the site, to 

 
 
 
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ensure for example Informed Consent, medical record keeping, and safety reporting and timeline 
are reviewed in detail with the sites. The training will include IMD usage and mitigation of residual 
risks. 
It is the responsibility of the Principal Investigator to ensure that all personnel involved in the 
investigation are fully informed of all relevant aspects of the investigation and have detailed 
knowledge of and training in the procedures that are to be executed by them. Any new information 
of relevance to the performance of this investigation must be forwarded to the staff involved in a 
timely manner. Magnus Falk and Panos Papachristou are the PIs for the investigation and have 
oversight at the 30 other clinical investigational sites. A more detailed information will be given in 
the document 07e_Site structure, GCP Resources and PI oversight_1.0_20Jan2022.  
The Investigator will keep a list of all personnel involved in the investigation together with their 
function and investigation related duties delegated. A Curriculum Vitae (CV) will be available for all 
staff delegated investigation-specific duties. 
9.7 
Statistical methods and determination of sample size 
9.7.1 
General 
Data from all variables will be presented by means of descriptive statistics and all data will be 
presented by line listings. 
Descriptive statistics implies providing the number of observations, number of missing data, 
minimum, median, maximum, mean and standard deviation for all continuous and ordered 
categorical data. Binary data and non-ordered categorical data will be presented by count and 
percentage in each category. 
9.7.2 
Demographics and other baseline characteristics 
Demographics and other baseline characteristics will be presented using descriptive statistics. 

 
 
 
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9.7.3 
Analysis of clinical performance  
9.7.3.1 
Primary Objective and Endpoint 
The primary objective of the investigation is to determine the diagnostic precision of the device; to 
answer at which level the AI tool Dermalyzer can identify malignant melanomas among cutaneous 
lesions that are assessed in clinical use due to any degree of malignancy suspicion.  
The primary endpoint will be measured as the true proportion;  by testing if the device based on 
artificial intelligence (AI) gives correct results as compared with the result of the lesion analysis (the 
final classification by PAD) in at least a certain proportion (π) of the analyses. 
9.7.3.2 
Secondary Objective and Endpoint 
The primary objectives are to evaluate usability and applicability in clinical praxis of Dermalyzer by 
users (medical professionals) and to gain an increased knowledge and understanding of how digital 
tools enhanced co-artificial intelligence can assist physicians with the right support for an earlier 
diagnosis of malignant melanoma. 
The second endpoint will be measured by User questions including System Usability Scale to 
evaluate the usability and applicability in clinical praxis. In addition to these endpoints, a number of 
analyses will be done that can be found in the SAP.  
9.7.3.3 Exploratory Objective and Endpoint 
The exploratory objective is to explore health economic aspects of improved diagnosis support. 
The exploratory endpoint will be measured by collecting health economic related information by 
survey to participating sites.  
9.7.4 
Analysis of safety  
9.7.4.1 
Endpoint 1 
The main risks identified for similar devices are incorrect diagnosis (false positives and false 
negatives) due to limitations in the training data set that was used to develop the software.  
According to the risk management, the only unacceptable risk identified for Dermalytics is that some 
individuals, including patients with ulcerations (damage to the skin) , external modification to the 
skin, absence of surrounding skin (normal skin around), will be excluded. This is stated in the IFU for 

 
 
 
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the IMD. The prevalence of incorrect diagnosis will be captured in the primary endpoint analysis, as 
well as the possibility of reduced risk of missing malignant melanomas (false negatives). The 
consequences of false negatives will be evaluated by collecting health economic data. To this end, 
the participating clinicians will be provided a survey with questions on how the use of Dermalytics 
would affect health economic aspects, such as time to treatment, number of visits to dermatologists 
and number of excisions.  
9.7.5 
Analysis data sets  
The data will be analysed using three analysis sets: 
·       Intention To Treat (ITT) 
o   All correctly (i.e., fulfill all entry criteria) included subjects are included in this 
analysis set. 
·       Per Protocol (PP) 
o   This is a subset of the ITT analysis set and all patients that are included in the ITT 
analysis and as well has followed all major procedures in the investigation (to be 
defined prior to start of the statistical analysis). 
·       Safety Analysis Set (SAS) 
o   Includes all subjects who have been exposed to the Demlayzer 
9.7.6 
Determination of sample size 
The general practitioner (GP) will only include subjects in the investigation with lesions where 
melanoma cannot be ruled out. All lesions where melanoma cannot be ruled out will be sent for an 
analysis (final classification) to confirm – or not confirm – if the suspected melanoma is a melanoma 
or not. Each lesion where melanoma cannot be ruled out will be analysed by the IMD and the IMD 
will classify each lesion where melanoma cannot be ruled out as “Low Risk of being a melanoma” 
(Low) or “High risk of being a melanoma” (High). 
In Table 1 the possible outcomes are described and (A+D)/(A+B+C+D) is the proportion of correct 
classifications by the IMD. 

 
 
 
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Table 1             Outcome (m = number of patients) for a binary variable where 
two groups of observations are linked together. 
  
The AI device 
High 
Low 
Total 
Final classification 
Melanoma 
A 
B 
A+B 
Not melanoma 
C 
D 
C+D 
Total 
A+C 
B+D 
A+B+C+D 
  
The expected value of (A+D)/(A+B+C+D) is denoted π and then the hypotheses of interest are 
H0: π ≤ π0 
H1: π > π0 
The null-hypothesis (H0) will be rejected if the one-sided p-value is less than a. If π = π1 the power to 
reject H0 should be β. 
Typically, a = 2.5 % and β = 80 % or 90 %. The p-value will be calculated using the exact Binomial test. 
In a successful investigation H0 is rejected and then H1 is accepted. 
 
 

 
 
 
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In Table 2 the needed number of lesions is presented based on the formula above and for statistical 
power 90%. 
Table 2        Number of lesions where melanoma cannot be ruled out needed to 
achieve 80% power to reject (i.e. get a one-sided p-value less than 
2.5%) the null-hypothesis by proportions to be rejected (i.e., π0) and by 
assumed true proportions (i.e. π1). Calculated by Sample Size a single proportion 
V01.xls. 
True Proportion 
(π1) 
Proportion to be rejected (π0) 
50% 
60% 
70% 
80% 
90% 
95% 
55% 
783 
. 
. 
. 
. 
. 
60% 
194 
. 
. 
. 
. 
. 
65% 
85 
742 
. 
. 
. 
. 
70% 
47 
182 
. 
. 
. 
. 
75% 
29 
78 
638 
. 
. 
. 
80% 
20 
43 
153 
. 
. 
. 
85% 
14 
26 
64 
471 
. 
. 
90% 
10 
17 
34 
108 
. 
. 
95% 
7 
11 
19 
42 
239 
. 

 
 
 
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100% 
4 
6 
9 
16 
35 
73 
 
 The set expectation of 95% true proportion is based on in-silico experiments on a proprietary dataset 
of images which found a sensitivity of 95.1∓0.6%. 
 The accuracy of AI decision support will be measured against gold standard (PAD) as well as against 
experienced dermatologists and general practitioners (average) and verified at: sensitivity> 95%, 
specificity> 75%, numbers needed to excise (NNE) <7, positive predictive value (PPV) )> 15% and 
negative predictive value (NPV)> 99.5%. The average sensitivity for general practitioners in previous 
meta-analyzes is estimated at about 81%.  
9.8 
Data Management 
The Principal Investigator or other qualified and delegated personnel will report data through Trial 
Online, a web based electronic Data Capture (EDC) system that manages electronic Case Report 
Forms (eCRFs). Trial Online is fully compliant with FDA 21 CFR Part 11, ISO-14155 and GDPR. 
The Data Manager will write a Data Management Plan (DMP) outlining the data management 
activities in this investigation. The Sponsor will review and approve the DMP. 
Each site personnel will receive a unique login to access the system. Site personnel will be trained 
before receiving access. All data must be entered in English. Any data to be recorded directly on the 
eCRFs (to be considered as source data) will be identified at the start of the study. The CRFs should 
always reflect the latest observations made during the subject’s participation in the investigation. 
Therefore, the CRFs should be completed as soon as possible during or after the subject’s visit. All 
data entries and changes done in the eCRF are captured in an audit trail. 
The Principal Investigator must verify that all data entries in the CRFs are accurate and correct by 
signing the completed CRF. Assessments that are not done or not applicable should be stated in the 
eCRF. The Data Manager and/or Monitor will check the quality of the data and query the data in the 
eCRF when needed. Pages cannot be signed before all queries are resolved. 
Each subject will receive a pseudonymised subject ID within the database. The code key will be kept 
separately by the site in a secure manner. 

 
 
 
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The electronic data retention period is of at least 10 years. Archiving of data is performed according 
to industry standards such as in PDF format. 
10 
EMERGENCY PROCEDURES 
The Principal Investigator is responsible for ensuring that procedures and expertise are available at 
the investigational site to handle medical emergencies during the investigation. 
For this investigation there are no foreseeable emergency situations since the IMD is a MDSW not in 
contact with the subjects or users. 
11 
MANAGEMENT OF THE INVESTIGATION 
11.1 CIP Amendments 
Any proposed change to the approved Final CIP (including appendices) will be documented in a 
written and numbered CIP amendment. All amendments including substantial changes to the CIP or 
to the Subject Information/ICF must be submitted to the appropriate IEC and Competent Authority 
for approval, according to applicable national regulations. 
11.2 Time table 
The end of the clinical part of the investigation is defined as the enrolment of approximately 500 
lesions where MM could not be ruled out, to reach the target of 239 evaluable (having PAD outcome 
result) lesions, with 12 positive PAD results. It is estimated that the PAD results will come from the 
laboratory within approximately 2 months time frame from each excision.  
The enrolment period of the investigation is expected to start in Quarter 1, 2022 and to be 
completed by Quarter 3, 2022.  
11.3 Discontinuation of the investigation 
The Sponsor reserves the right to discontinue the investigation at any time, but intends only to 
exercise this right for significant and documented reasons (e.g. valid scientific or administrative 
reasons, risk to the subjects or non-compliance by the Investigator). 

 
 
 
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After such a decision all CRFs should be completed as far as possible. 
The Sponsor must inform the Competent Authority and IEC concerned as appropriate about any 
premature termination. 
11.4 Reporting and publication of investigation results 
A Clinical Investigation Report, in compliance with ISO 14155, Annex D, describing the conduct of the 
investigation, the statistical analysis performed and the results obtained, will be prepared by RÖ/KI. 
A summarizing report will be submitted to the Competent Authorities within 12 months from end of 
investigation (last histopathology result received and entered in eCRF) or be available on request, as 
per local requirements.  
If the duration of the investigation exceeds one year, the Sponsor must submit an annual safety 
report to the Competent Authority and to the IEC, if applicable. The report will summarize any SAEs 
and contain an update of the risk-benefit evaluation if there has been any change since the approval 
of the clinical investigation. 
The aim is to prepare a scientific publication to describe the results from the clinical investigation, 
based on the report results. 
11.5 Disclosure and confidentiality 
All unpublished information concerning the IMD and research carried out by the Sponsor, including 
patent applications, manufacturing processes, basic scientific data, etc., is considered confidential 
and the sole property of the Sponsor/AIMT. Disclosure to third parties must be limited to those 
undertaking legitimate peer review of the scientific and ethical aspects of the investigation and to 
those participating, including the recipients of IMD, so that customary medical care and informed 
consent can be achieved. 
− 
The clinical investigation will be registered in a publicly accessible database e.i 
clinicaltrials.gov.  
− 
The results of the clinical investigation will be made publicly available. 

 
 
 
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11.6 Archiving 
The Principal Investigator is responsible for maintaining essential documents, (as defined in EN ISO 
14155, Annex E) for 10 years after finalization of the Clinical Investigation Report. This includes any 
original source documents related to the investigation, the Subject Identification List (providing the 
sole link between named subject source records and anonymous CRF data), the original signed ICFs 
and detailed records of disposition of IMD.  
It is the responsibility of the Sponsor to inform the Principal Investigator/institution as to when these 
documents no longer need to be retained. 
The Sponsor will archive the Sponsor File in accordance with EN ISO 14155, Annex E, and applicable 
regulatory requirements. 
11.7 Insurance/indemnity         
Subjects will be covered under Sponsor liability insurance policy through “Patientskadeförsäkringen” 
or comparable insurance if any private clinic participates as an investigational site. The participating 
subjects are protected in accordance with national regulations, as applicable.  
11.8 Agreements 
The sites included in the clinical investigation will not receive any payment from the sponsor to 
participate in the clinical investigation. The sites have agreed to perform the clinical investigation pro 
bono. Per each site, the Investigator must comply with all the terms, conditions, and obligations of 
the Clinical Investigation Agreement and Data Protection Agreement for this investigation. The 
Clinical Investigator Agreement will be signed by the operations manager at each site, that has also 
signed the CDA, to ensure that each site has sufficient resources available. Each site has confirmed 
their ability to participate in the clinical investigation.  
Agreements between Sponsor and the investigational site must be in place before any investigation-
related procedures can take place, or subjects be enrolled. 
 
 

 
 
 
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12 
REFERENCES 
 
1. Matthews, N. H., Li, W.-Q., Qureshi, A. A., Weinstock, M. A. & Cho, E. Epidemiology of 
Melanoma. in Cutaneous Melanoma: Etiology and Therapy (eds. Department of Surgical 
Oncology, Fox Chase Cancer Center, Philadelphia,PA, USA, Ward, W. H., Farma, J. M., & 
Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia,PA, USA) 3–22 (Codon 
Publications, 2017). doi:10.15586/codon.cutaneousmelanoma.2017.ch1. 
2. Tsatmali, M., Ancans, J. & Thody, A. J. Melanocyte Function and Its Control by Melanocortin 
Peptides. J Histochem Cytochem. 50, 125–133 (2002). 
3. Ward, W. H. & Farma, J. M. Cutaneous melanoma: etiology and therapy. (2017). 
4. Burnet, N. G., Jefferies, S. J., Benson, R. J., Hunt, D. P. & Treasure, F. P. Years of life lost (YLL) 
from cancer is an important measure of population burden — and should be considered when 
allocating research funds. Br J Cancer 92, 241–245 (2005). 
5. Global Cancer Observatory. https://gco.iarc.fr/. 
6. Jones, O. T., Ranmuthu, C. K. I., Hall, P. N., Funston, G. & Walter, F. M. Recognising Skin Cancer in 
Primary Care. Adv Ther 37, 603–616 (2020). 
7. Voss, R., Woods, T., Cromwell, K., Cormier, J. & Nelson, K. Improving outcomes in patients with 
melanoma: strategies to ensure an early diagnosis. PROM 229 (2015) 
doi:10.2147/PROM.S69351. 
8. Argenziano, G. et al. Accuracy in melanoma detection: A 10-year multicenter survey. Journal of 
the American Academy of Dermatology 67, 54-59.e1 (2012). 
9. Ekström, C. & Helenason, J. AI-based malignant melanoma diagnostic decision support system 
for general practitioners Feasibility study with convergent mixed methods research. (Stockholm 
University, 2021). 
10. Menvielle, L., Audrain-Pontevia, A.-F. & Menvielle, W. The Digitization of Healthcare. (2017). 
11. Topol, E. J. High-performance medicine: the convergence of human and artificial intelligence. 
Nat Med 25, 44–56 (2019). 
12. Dwivedi, Y. K. et al. Artificial Intelligence (AI): Multidisciplinary perspectives on emerging 
challenges, opportunities, and agenda for research, practice and policy. International Journal of 
Information Management 57, 101994 (2021). 
13. Wiljer, D. & Hakim, Z. Developing an Artificial Intelligence–Enabled Health Care Practice: 
Rewiring Health Care Professions for Better Care. Journal of Medical Imaging and Radiation 
Sciences 50, S8–S14 (2019). 

 
 
 
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14. Shinners, L., Aggar, C., Grace, S. & Smith, S. Exploring healthcare professionals’ understanding 
and experiences of artificial intelligence technology use in the delivery of healthcare: An 
integrative review. Health Informatics J 26, 1225–1236 (2020).

 
 
 
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13 
APPENDICES 
13.1 Signature pages 
 
 
“I agree to the terms of this Clinical Investigation Plan (CIP).” 
 
 
Sponsor signatory 
 
 
Magnus Falk, MD, assoc.professor 
 
Signature 
 
Date 
 
 
 
Sponsor Medical Officer 
 
 
Panos Papachristou , MD, PhD,  
 
Signature 
 
Date 
 
 

 
 
 
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Manufacture signatory 
 
 
Christoffer Ekström, CEO 
 
Signature 
 
Date 
 
 
 
13.1     Signature pages 
 
 
 
Coordinating/Principal Investigator(s) 
 
“I agree to the terms of this Clinical Investigation Plan (CIP). I will conduct the investigation in 
accordance with the procedures specified in the CIP, the ethical principles in the latest version of the 
Declaration of Helsinki, ICH Good Clinical Practice, ISO 14155 any other applicable regulatory 
requirements”. 
 
 
 
 
Magnus Falk, MD, assoc.professor 
 
Signature 
 
Date 
 
 
 
 

 
 
 
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13.2 Declaration of Helsinki 
http://www.up.ac.za/media/shared/Legacy/sitefiles/file/45/2875/declarationofhelsinki_fortaleza_br
azil2013.pdf 
 
 

 
 
 
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13.3 Instructions for use  
13.4 List of participating sites 
13.5 Clinical Investigation Summary Safety Report Form_1.0_20Jan2022