1. Use

• professional medical imaging and analysis test non-invasive screening aid

• indicates chance of melanoma in pigmented skin lesions (moles)

• intended for use by authorised (trained) operators (medical professional) as adjunct screening technology in the management of suspect lesions
  

2. On-device AI

• supplied as proprietary software on a single-application iOS device

• secure image capture with all other functions disabled

• nomela® test and analysis by machine-learning AI made directly on the device

• no requirement to internet connectivity for test and analysis completion

• not an on-line web-based application
  

3. User management, Quality and IT security

• authorised user management: site and date/time information, patient identification, region & close-up images (for unequivocal identification of lesions), multiple lesion test capacity; e-consent included if required

• no requirement for dermatoscopic images

• QMS ISO13485 certified with regular audit by Notified Body (BSi); IT security certified by Cyber Security Plus and NHS DSP Toolkit; MDR Class IIa in process
  

4. Analysis technology

• nomela® analysis subject to:
  i) no contra-indications (operator confirms)
  ii) distinct edge obtained (automated)
  iii) size of lesion (not less than 5mm diameter including calculation by the test)

• analysis technology employs proprietary automated lesion edge detection and on-device machine-learning AI
  

5. Result and Reporting

• only a few minutes required to complete the image capture, analysis and report

• Result shown on the device screen as value (0 to 1) for chance of melanoma

• Report shows user and patient information, high-quality images and nomela® analysis result(s)

• Upload by cellular (4G/5G) connection via AWS serverless server to secure (nhs.net) email or to allow access by authorised ePR

6. Performance

The performance of the nomela® v6 AI system is equivalent to (dermatologist) experts assessing the same testing subset of images.