Table 3 Examples of two intended use statements which had a score of 6/6 items present (complete) and two examples that had a score of maximal 2/6 items present (incomplete)
Example | Total score | Presence of | Absence of |
|---|---|---|---|
“[PRODUCT]’s intended use is to assist trained interpreting operators in analysing the breast ultrasound images of patients with soft tissue breast lesions who have been referred for further diagnostic ultrasound examination, either from screening programmes or referred for work up of a suspected breast lesion. It provides a categorical discrete output, which aligns with ACR Breast Imaging-Reporting and Data System (BI-RADS) categories or the U1-U5 Classification System per the European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis to help trained interpreting operators improve their overall accuracy as well as reduce inter- and intra-operator variability The software’s PACS function also enables users to review other breast imaging but is not intended to be used to guide diagnostic or management decisions.” | 6/6 | Indication, body part, environment, user, patient population, and operating principle | / |
“[PRODUCT] is indicated for subjects at risk of Alzheimer’s disease dementia on the recommendation of neurology specialists. Radiology specialists with neuroradiological expertise can use [PRODUCT] to support the reporting of brain MRI investigations in these subjects. Neurology specialists can use [PRODUCT] as an aid to diagnosis and prognosis [PRODUCT] software provides the subject level of risk (low risk or high risk) of being affected by or progressing to Alzheimer’s disease dementia within 24 months of the date of the [PRODUCT] processed examination, i.e., the subject’s brain MRI investigation, possibly in combination with a neuropsychological examination performed no earlier than and no later than one month from the brain MRI However, it should be noted that [COMPANY] considers [PRODUCT] as a support to the neurologists in their diagnosis and prognosis, and as a support to the radiology specialists with neuroradiological expertise in their reporting of brain MRI investigations, who have the sole decision making responsibility.” | 6/6 | Indication, body part, environment, user, patient population, and operating principle | / |
“[PRODUCT] provides CAC analysis by segmentation of four main artery (right coronary artery, left main coronary, left anterior descending and left circumflex artery then extracts calcium on coronary artery to provide Agatston score, volume score and mass score by whole and each segmented artery type. Based on the score, provides CAC risk based on age and gender.” | 2/6 | Body part and operating principle | Indication and environment, operating principle |
“[COMPANY] artificial intelligence software for prioritization of radiographs and emphasis of abnormalities.” | 1/6 | Operating principle | Indication, body part, environment, user, and patient population |