Table 1 Description of defined item derived from the intended use statements
Item | Short description | Question | Example from intended use statement |
|---|---|---|---|
Intended medical indication/disease targeted | Condition and/or disease to be screened, monitored, treated, diagnosed, or prevented | What specific medical conditions are you targeting, and what clinical claims are you making? | “The intended use of [PRODUCT] is to perform an automatic determination of bone age and bone health index (BHI).” |
Intended part of the body | Part of the body or type of tissue applied to or interacted with | What body part is your product addressing? | “[PRODUCT] indicated for use in the analysis of CT studies of the abdomen.” |
Intended patient population | Patient population according to age, health, or condition | What specific patient group is your product aimed at? | “[PRODUCT] uses the screening mammograms of the female population.” |
Intended user profile | The user according to the role, educational level, and training | Who are the intended users of your AI solution? What expertise or training is required from these users? | “[PRODUCT] is to be used by qualified medical professionals who are credentialed by their medical institutions to review chest radiographs.” |
Intended use environment | Physical (e.g., emergency department, screening) and technical (hardware requirements) environment | Where exactly do you envision your product being used (e.g., on a stand-alone app, integrated)? In what clinical setting (screening, acute care, low-income country, etc.)? | “The device is intended to be used when the patient is not in a life-threatening state of health, time is not critical for medical decisions and no major therapeutic interventions are required.” and/or “[PRODUCT] uses a […] standalone Web application in parallel to the ongoing standard of care image interpretation.” |
Intended operating principle | Method used to accomplish the intended purpose and mechanism by which it works | What is the input, computational task, and output of your product? How should the user be using the outcomes (triage, stand-alone, concurrent, etc.)? | “[PRODUCT] is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations […] It is used to aid users in making a final diagnosis and patient management decisions by providing adjunctive information.” |
Disclaimers | Warnings and contraindications for use | How should the product be used or not be used? What is foreseeable misuse? | “[PRODUCT] is not an interpretive or diagnostic aid and should be used only as adjunctive information when the final assessment […] is made by an […] interpreting physician.” |