Table 2. Experience of 223 respondents with experience of using AI-SaMD: characteristics of AI-SaMD and its usage.
| AI-SaMD characteristics | Number of responses (%) | |
|---|---|---|
| Numbers of used AI-SaMDs* | ||
| One | 81 (36.3) | |
| Two | 67 (30.0) | |
| Three or more | 75 (33.6) | |
| Length of usage period* | ||
| Less than 6 months | 70 (31.4) | |
| 6 months to 1 year | 44 (19.7) | |
| 1–2 years | 54 (24.2) | |
| 2–3 years | 32 (14.3) | |
| 3 years or longer | 23 (10.3) | |
| Regulatory approval* | ||
| Ministry of Food and Drug Safety of Korea approval | 183 (82.1) | |
| Research purpose use before approval | 103 (46.2) | |
| Function of AI-SaMD* | ||
| Detection of radiological finding | 183 (82.1) | |
| Lesion diagnosis and classification | 123 (55.2) | |
| Automated measurement and quantification | 75 (33.6) | |
| Improvement of image quality | 33 (14.8) | |
| Reduction of image acquisition time | 15 (6.7) | |
| Prioritization of image interpretation | 10 (4.5) | |
| Target image modality* | ||
| Plain radiography | 139 (62.3) | |
| CT | 95 (42.6) | |
| Mammography | 65 (29.1) | |
| MRI | 64 (28.7) | |
| Ultrasonography | 8 (3.6) | |
| Motivation for AI-SaMD usage* | ||
| Purchase by the institution | 105 (47.1) | |
| To conduct research using AI-SaMD | 93 (41.7) | |
| To improve the efficiency of practice | 71 (31.8) | |
| To experience the clinical performance of AI-SaMD | 71 (31.8) | |
| To improve the quality of practice | 67 (30.0) | |
| Integration with PACS | ||
| All AI results sent to PACS | 153 (68.6) | |
| Summaries of AI results sent to PACS; access to separate workstation required for full results | 29 (13.0) | |
| AI results not sent to PACS | 37 (16.6) | |
| No response | 4 (1.8) | |
*Multiple responses allowed.
AI-SaMD = artificial intelligence-based software as medical device, PACS = picture archiving and communication system