Table 1 Characteristics of 14 studies using standalone DL systems and 12 studies using assistive DL systems.
Study | Design | Site | Patient | US vendor‡ | Index test | Comparator | BIRADS lexicon | Cutoff value | Reference standard |
|---|---|---|---|---|---|---|---|---|---|
Standalone DL system | |||||||||
Kim 202118 | Retrospective | 1 (Korea) | 146 | RS85 Prestige | S-Detect | 2 human readers (1 with 6-year experience, 1 with 3-month experience in breast imaging) | 5th | 4a | Pathology |
Xiao 201919 | Prospective | 1 (China) | 437 | RS80 Prestige | S-Detect | 2 human readers (1 experienced, 1 resident) | 5th | 4a | Pathology |
Cho 201820 | Prospective | 1 (Korea) | 116 | RS80A | S-Detect | 2 human readers (1 with 7-year experience, 1 with 1-year experience in breast imaging) | 5th | 4a | Pathology Follow up (>2 year) |
Segni 201822 | Prospective | 1 (Italy) | 61 | RS80A | S-Detect | 5 human readers (1 experienced, 4 in-training residents) | 5th | 4a | Pathology Follow up (<2 years) |
Xia 202123 | Prospective | 1 (China) | 40 | RS80A | S-Detect | 4 human readers (2 senior, 2 junior) | NR† | 4b | Pathology |
Lee 202224 | Retrospective | 1 (Korea) | 472 | RS80A | S-Detect | 6 human readers (3 experienced, 3 inexperience) | NR | 4a | Pathology Follow up (>2 year) |
Choi 201925 | Retrospective | 1 (Korea) | 226 | RS80A | S-Detect | 4 human readers (2 senior, 2 junior) | NR | 4a | Pathology Follow up (7–28 months) |
Nicosia 202226 | Retrospective | 1 (Italy) | 210 | RS80A | S-Detect | 4 human readers (2 senior, 2 junior) | NR | 4b | Pathology |
Lai 202227 | Retrospective | 1 (China) | 172 | Philips iU22 Toshiba Aplio 500 Canon Aplio i800 | BU-CAD | 16 human readers | 5th | 4a | Pathology Follow up (>2 year) |
Lee 201928 | Retrospective | 1 (Korea) | 413 | RS80A | S-Detect | 10 human readers (5 experienced, 5 inexperience) | NR | 4a | Pathology Follow up (>1 year) |
Wei 202129 | Prospective | 1 (China) | 192 | RS80A | S-Detect | 4 human readers (2 experienced, 2 inexperience) | 5th | 4a | Pathology |
Wei 202230 | Prospective | 9 (China) | 901 | RS80A | S-Detect | 4 human readers (2 experienced, 2 inexperience) | 5th | 4a 4b | Pathology |
Ciritsis 201931 | Retrospective | Training set: 1 site (country NR†) Test set: public dataset (multiple sites) | 582 | NR | In-house | 2 human readers (over 8 years of experience) | 5th | 4a | Pathology Follow up (time NR†) |
Gu 202232 | Prospective | Training set: 32 sites (China) Test set: public dataset (multiple sites) | 5012 | Resona7 Resona7s Resona7T Resona8 Resona8T DC-80 | In-house | 5 human readers (2 experienced, 3 inexperience) | NR | 4a | Pathology |
Assistive DL system | |||||||||
Park 201917 | Retrospective | 1 China | 91 | RS80A | Human readers + S-Detect | 5 human readers (3 less experienced, 2 experienced) | 5th | 4a | PathologyFollow up (6–35 months) |
Kim 202118 | Retrospective | 1 (Korea) | 146 | RS85 Prestige | Human readers + S-Detect | 2 human readers (with 6-year and 3-month experience in breast imaging, respectively) | 5th | 4a | Pathology |
Cho 201820 | Prospective | 1 (Korea) | 116 | RS80A | Human readers + S-Detect | 2 human readers (with 7- and 1 1-year experience in breast imaging, respectively) | 5th | 4a | Pathology Follow up (>2 year) |
Wang 202121 | Prospective | 1 (China) | 167 | RS80A | Human readers + S-Detect | 2 human readers (with 8- and 10-year experience in breast US, respectively) | NR | 4a | Pathology |
Xia 202123 | Prospective | 1 (China) | 40 | RS80A | Human readers + S-Detect | 4 human readers (2 senior, 2 junior) | NR | 4b | Pathology |
Lee 202224 | Retrospective | 1 (Korea) | 472 | RS80A | Human readers + S-Detect | 6 human readers (3 experienced, 3 inexperience) | NR | 4a | Pathology Follow up (>2 year) |
Choi 201925 | Retrospective | 1 (Korea) | 226 | RS80A | Human readers + S-Detect | 4 human readers (2 senior, 2 junior) | NR | 4a | Pathology Follow up (7–28 months) |
Lai 202227 | Retrospective | 1 (China) | 172 | Philips iU22 Toshiba Aplio 500 Canon Aplio i800 | Human readers + BU-CAD | 16 human readers | 5th | 4a | Pathology Follow up (>2 year) |
Lee 201928 | Retrospective | 1 (Korea) | 413 | RS80A | Human readers + S-Detect | 10 human readers (5 experienced, 5 inexperience) | NR | 4a | Pathology Follow up (>1 year) |
Wei 202129 | Prospective | 1 (China) | 192 | RS80A | Human readers + S-Detect | 4 human readers (2 experienced, 2 inexperience) | 5th | 4a | Pathology |
Wei 202230 | Prospective | 9 (China) | 901 | RS80A | Human readers + S-Detect | 4 human readers (2 experienced, 2 inexperience) | 5th | 4a 4b | Pathology |
Gu 202232 | Prospective | Training set: 32 sites (China) Test set: public dataset (multiple sites) | 5012 | Resona7 Resona7s Resona7T Resona8 Resona8T DC-80 | Human readers + In-house AI system | 5 human readers (2 experienced, 3 inexperience) | NR | 4a | Pathology |
