T-012-015 Summative evaluation report YYYY_nnn
Objective
This study aims to validate through objective and empirical evidence that the intended users of the medical device can use the device easily and safely.
Abbreviations and definitions
- Instruction for use: following the Medical Device Regulation, the term `instructions for use refers to the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken
- Intended user: Users are defined in
IEC 62366-1:2015as persons interacting with (i.e. operating or handling) the medical device. - Summative user testing: It (quantitative testing) provides an indirect assessment of the usability of the design. A group of testers are given a task, and based on their performance, the usability quotients of the design elements are measured.
- Tester: a person who has been asked to perform the tasks described in the present protocol.
- eIFU : Electronic instruction for use
- IFU: Instruction for use
- URRA: Use related risk analysis
Device description
Device Identification
| Information | |
|---|---|
| Device name | Legit.Health Plus (hereinafter, the device) |
| Model and type | NA |
| Version | 1.1.0.0 |
| Basic UDI-DI | 8437025550LegitCADx6X |
| Certificate number (if available) | MDR 792790 |
| EMDN code(s) | Z12040192 (General medicine diagnosis and monitoring instruments - Medical device software) |
| GMDN code | 65975 |
| Class | Class IIb |
| Classification rule | Rule 11 |
| Novel product (True/False) | FALSE |
| Novel related clinical procedure (True/False) | FALSE |
| SRN | ES-MF-000025345 |
Intended use
The device is a computational software-only medical device intended to support health care providers in the assessment of skin structures, enhancing efficiency and accuracy of care delivery, by providing:
- quantification of intensity, count, extent of visible clinical signs
- interpretative distribution representation of possible International Classification of Diseases (ICD) categories.
Quantification of intensity, count and extent of visible clinical signs
The device provides quantifiable data on the intensity, count and extent of clinical signs such as erythema, desquamation, and induration, among others; including, but not limited to:
- erythema,
- desquamation,
- induration,
- crusting,
- xerosis (dryness),
- swelling (oedema),
- oozing,
- excoriation,
- lichenification,
- exudation,
- wound depth,
- wound border,
- undermining,
- hair loss,
- necrotic tissue,
- granulation tissue,
- epithelialization,
- nodule,
- papule
- pustule,
- cyst,
- comedone,
- abscess,
- draining tunnel,
- inflammatory lesion,
- exposed wound, bone and/or adjacent tissues,
- slough or biofilm,
- maceration,
- external material over the lesion,
- hypopigmentation or depigmentation,
- hyperpigmentation,
- scar,
- ictericia
Image-based recognition of visible ICD categories
The device is intended to provide an interpretative distribution representation of possible International Classification of Diseases (ICD) categories that might be represented in the pixels content of the image.
Device description
The device is a computational software-only medical device leveraging computer vision algorithms to process images of the epidermis, the dermis and its appendages, among other skin structures. Its principal function is to provide a wide range of clinical data from the analyzed images to assist healthcare practitioners in their clinical evaluations and allow healthcare provider organisations to gather data and improve their workflows.
The generated data is intended to aid healthcare practitioners and organizations in their clinical decision-making process, thus enhancing the efficiency and accuracy of care delivery.
The device should never be used to confirm a clinical diagnosis. On the contrary, its result is one element of the overall clinical assessment. Indeed, the device is designed to be used when a healthcare practitioner chooses to obtain additional information to consider a decision.
Intended medical indication
The device is indicated for use on images of visible skin structure abnormalities to support the assessment of all diseases of the skin incorporating conditions affecting the epidermis, its appendages (hair, hair follicle, sebaceous glands, apocrine sweat gland apparatus, eccrine sweat gland apparatus and nails) and associated mucous membranes (conjunctival, oral and genital), the dermis, the cutaneous vasculature and the subcutaneous tissue (subcutis).
Intended patient population
The device is intended for use on images of skin from patients presenting visible skin structure abnormalities, across all age groups, skin types, and demographics.
Intended user
The medical device is intended for use by healthcare providers to aid in the assessment of skin structures.
User qualification and competencies
In this section we specificy the specific qualifications and competencies needed for users of the device, to properly use the device, provided that they already belong to their professional category. In other words, when describing the qualifications of HCPs, it is assumed that healthcare professionals (HCPs) already have the qualifications and competencies native to their profession.
Healthcare professionals
No official qualifications are needes, but it is advisable if HCPs have some competencies:
- Knowledge on how to take images with smartphones.
IT professionals
IT professionals are responsible for the integration of the medical device into the healthcare organisation's system.
No specific official qualifications are needed, but it is advisable that IT professionals using the device have the following competencies:
- Basic knowledge of FHIR
- Understanding of the output of the device.
Use environment
The device is intended to be used in the setting of healthcare organisations and their IT departments, which commonly are situated inside hospitals or other clinical facilities.
The device is intended to be integrated into the healthcare organisation's system by IT professionals.
Operating principle
The device is computational medical tool leveraging computer vision algorithms to process images of the epidermis, the dermis and its appendages, among other skin structures.
Body structures
The device is intended to use on the epidermis, its appendages (hair, hair follicle, sebaceous glands, apocrine sweat gland apparatus, eccrine sweat gland apparatus and nails) and associated mucous membranes (conjunctival, oral and genital), the dermis, the cutaneous vasculature and the subcutaneous tissue (subcutis).
In fact, the device is intended to use on visible skin structures. As such, it can only quantify clinical signs that are visible, and distribute the probabilities across ICD categories that are visible.
Risk management
We conducted a task analysis on the use of the device which led to a comprehensive use-related risk analysis and list of potential use errors. This process involved analyzing known use problems with similar devices and/or previous versions of the device, identifying the user interface characteristics related to safety, identifying potential use errors, and identifying known and foreseeable hazards and hazardous situations.
Include a table coming from the Use-related risk analysis with the hazards related to usability.
Summative evaluation testing
Method
Insert a general description of the study design: timing, methods, description of the tasks to be performed by the testers, version of the software used in the test, version of the IFU.
Participants or testers
The study was conducted with insert number of participants participants who are representative of the intended users.
The user profile is the following: insert user profile.
Insert details about the participants, such as full name, role, healthcare organization, and statement that participants met the user profile described above.
Test environment
Insert a description of the test environment.
Test results
Data analysis
Explain the methods used to analyze the collected data, including any metrics.
Findings
Summarize the results of the test and their analysis with the established success criteria, and key findings from the summative evaluation test, including both positive outcomes and areas for improvement.
Use errors
List any use errors identified during testing, along with their potential impact and frequency of occurrence.
Information about safety
Describe whether information for safety could correctly be perceived and understood by the users and whether it supported the correct use of the medical device.
User feedback
Provide a summary of qualitative feedback received from test participants, highlighting any common themes or significant insights.
Conclusions
The final discussion about the results should contain the following: whether all tests were successfully passed, whether all risks related to usability are acceptable, and whether additional data about usability shall be collected as part of the post-market surveillance activities.
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003, JD-004
- Approver: JD-001
Delete this section when you create a new record from this template.
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003, JD-004
- Approver: JD-001