Table 2

Final target product profile for an ROP imaging device

PROptimal
Refers to the ideal target		Minimal
Refers to the lowest acceptable or bare minimum
Use case
PR1Intended useScreening/Diagnosis of ROP in neonates
PR2Target operatorFor use in low-income and middle-income countries by a wide variety of healthcare professionals including ophthalmologists, neonatal nurses, clinical officers and technicians and non-clinicians
PR3Target populationNeonates (primarily premature and/or low birth weight, at risk for ROP)
PR4Target settingNeonatal units and/or eye department in hospitals in low-resource settings
Safety and standards
PR5Manufacturers’ quality management systemISO 13485:2016 medical devices—quality management systems—requirements for regulatory purposes
PR6Device regulatory statusAt least one of: CE marking, approved by US FDA or another stringent regulatory body of a founding member of International Medical Device Regulators Forum (IMDRF) (eg, Japan or Australia or Canada)
Technical characteristics
PR7Field of view170 degrees36 degrees used with an appropriate condensing lens to be able to view the peripheral retina (into zone 3)
PR8Image resolution2048×2048 pixels, 24-bit colours750×1334 pixels
PR9ImagingAll three modes available: still, burst mode, videoStill images captured from video
PR10WavelengthColour fundus: white LED (wavelength range 400–750 nm with a peak near 600 nm)
Fundus fluorescence angiography: blue LED (dominant wavelength at 480 nm)
PR11IlluminationIntegrated bright light, 100–6000 lx
PR12Adjustment of imagesIntensity, gain, balance, brightness, contrast, red free, gamma and focusSmartphone image editing services
PR13Dilation needsNo dilation requiredYes, dilation required
PR14Time to result for imaging3–4 min10 min
PR15Image output formatJPEG, PNG, DICOM, MPEG, HEIC, PACS supportMPEG, HEIC, DICOM
PR16System integration*Ability to output to cloud-based support systemStandalone device with ability to output and share images
PR17Clinical accuracy100% sensitivity; 99.8% specificity for ROP needing treatment100% sensitivity; 95% specificity for ROP needing treatment
PR18AccessibilityPortable: handheld or mobilePortable
PR19Device weight (for imaging capture component)<720 gNo more than 720 g
PR20Patient interfaceNon-contactNon-invasive contact
Training and maintenance
PR21User instructionsUser manual and additional training materials (checklists, videos, guides) in at least one national official language for the country of intended use. Attached to device with labels and markings where possibleUser manual provided in at least one national official language
PR22Preventive maintenancePreventive maintenance included with additional training materials (checklists, videos, guides)Manual for preventive maintenance included
PR23DecontaminationEasy to clean surfaces, compatible with common disinfecting agents
Power requirements
PR24Power sourceMains with rechargeable battery or solar powered without mains powerMains power
PR25BatteryProvides battery backup, autonomy >5 hours, automatic switch to battery in case of power failure, automatic recharge on connection to mainsBattery or power-pack backup
PR26VoltageOutput spike, surge and transient protection (including lightning), with availability of type I and type II International Electrotechnical Commission (IEC) rating lightning surge protection. Voltage and power input and output meteringModel must match the voltage and frequency of the purchasing country’s local power grid (eg, 110–120 Volts Alternating Current (VAC) at 60 Hz or 220–240 VAC at 50 Hz)
Durability and lifetime requirements
PR27ConsumablesNonePupil dilation drops
Purchasing considerations
PR28Price†<US$500 ex-works<US$25 000 ex-works
PR29Warranty5 years1 year

  • *This is a new product requirement that was developed following the consensus meeting due to the consolidation of various product requirements included in the initial TPP survey. Please refer to the TPP report discussion of PR16: system integration for additional detail and further context.

  • †There was not 75% voting agreement on both the optimal and minimal product requirement. Please refer to the TPP report discussion of PR28: price for additional detail.

  • FDA, Food and Drug Administration; PR, product requirement; ROP, retinopathy of prematurity; TPP, target product profile.