Intended use or purpose

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 analysed 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 organisations in their clinical decision-making process, thus enhancing the efficiency and accuracy of care delivery.

The device does not provide a clinical diagnosis

The device should never be used to confirm a clinical diagnosis. Its result is one element of the overall clinical assessment. The device is designed to be used when a healthcare practitioner chooses to obtain additional information to consider a decision.

Indications for use

The device is intended for two different scenarios:

1. Assessing skin structures (dermatoses)
2. Assessing facial palsy

More concretely, the device is indicated for the following uses:

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,
• dryness,
• oedema,
• oozing,
• excoriation,
• swelling,
• lichenification,
• exudation,
• depth,
• edges,
• undermining,
• pustulation,
• hair density,
• type of necrotic tissue,
• amount of necrotic tissue,
• type of exudate,
• peripheral tissue edema,
• peripheral tissue induration,
• granulation tissue,
• epithelialization,
• nodule count,
• papule count,
• pustule count,
• cyst count,
• comedone count,
• abscess count,
• draining tunnel count,
• lesion count,
• facial palsy

Body structures

The device is intended for 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 for use on visible skin structures. As such, it can only quantify clinical signs that are visible, and distribute the probabilities across ICD classes that are visible.

For the assessment of facial palsy, the device is intended to be used specifically on the face.

Image-based recognition of visible ICD classes

The device is intended to provide an interpretative distribution representation of possible International Classification of Diseases (ICD) classes that might be represented in the pixel content of the image.

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.

For the assessment of facial palsy, the device is intended for use on patients presenting facial nerve injury.

The performance of the device may vary across demographic subgroups within this population. See Population and performance variability.

Intended user

The intended users are healthcare organisations and their stakeholders, including Health Care Practitioners (HCP).

Information Technology professionals

Regarding usability, the Information Technology professionals who integrate the device are considered a relevant stakeholder.

Contraindications

We advise the user not to use the device on the following skin structures:

• Skin structures that are not accessible by a camera, such as being located in a skin fold or is otherwise covered.
• Skin structures that contain a scar or fibrosis consistent with previous trauma.
• Skin structures where the skin is very damaged (i.e., very ulcerated or bleeding lesions).
• Skin structures greater than 1 cm away from the eye.
• Skin structures that contain foreign matter (i.e., tattoo, cream).
• Skin structures located on special anatomic sites (i.e., under the nail).
• Skin structures surrounded or covered by a significant amount of hair.

Risk factors

After analysing the risks associated with the use of the device, we have identified some residual risks.

The following table summarises the residual risks and the recommended course of action for each of them.

#	Situation	Recommended course of action
1	The quality of the image is not high enough for the device to perform correctly	These Instructions for Use contain extensive guidance on how to take pictures, in a section called 'How to take pictures'. We also offer training to users to improve the imaging process so that it is optimal for the device's operation. Such training can be requested from your nearest sales representative. Also, we encourage you to pay attention to the information regarding image quality that the device outputs alongside the clinical information.
2	The device receives images that do not represent skin structure	These Instructions for Use contain extensive guidance on how to take pictures, in a section called 'How to take pictures'. Also, we encourage you to pay attention to the information regarding image domain that the device outputs alongside the clinical information.
3	The user is unable to provide adequate lighting conditions	This is similar to the previous risks, but it has a very simple solution: use the flash. If you cannot use the flash and the image is still dark, move to a different environment with better lighting. Also, we encourage you to pay attention to the information regarding image quality that the device outputs alongside the clinical information.
4	The device outputs a wrong result to the care provider organisation, resulting in the storage of erroneous information in the organisation's software, or to the HCP, resulting in erroneous information during their assessment	The device must always be used under the supervision of an HCP, who should confirm or validate the output of the device considering the medical history of the patient, and other possible symptoms they could be suffering, especially those that are not visible or have not been supplied to the device.
5	The HCP validates the wrong skin condition, even if the device outputs the correct result.	Keep in mind that the device should be used by trained HCPs. Also, we recommend adding a warning in your software to remind your users of the importance of correctly validating the conditions.