Expert consensus on evaluation indicators for the application of domestic high-end thoracoscopic thoracic surgery_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

 CHEN Chang , Shanghai Medical Association Thoracic Surgery Branch , Shanghai Medical Doctor Association Thoracic Surgery Physician Branch , General Thoracic Surgery Clinical Capacity Promotion and Improvement Alliance

Department of Thoracic Surgery, Shanghai Pulmonary Hospital Affiliated to Tongji University, Shanghai, 200433, P. R. China;

Corresponding?author：

CHEN Chang, Email: chenthoracic@163.com

Keywords：

4K fluorescence; medical endoscopes; thoracic surgery; clinical application; evaluation system; expert consensus

DOI：

10.7507/1007-4848.202509054

Video：

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[Abstract] The rapid development of domestically produced high-end medical endoscopes, particularly those incorporating 4K ultra-high-definition and fluorescence imaging, has shown significant promise in minimally invasive thoracic surgery. This expert consensus systematically delineates the clinical applications and value of these advanced technologies in various thoracic procedures, including wedge resection, anatomical segmentectomy, and bronchial sleeve resection. Furthermore, it establishes a scientific, quantitative evaluation system for these domestic thoracoscopes. The proposed framework comprises four primary indicators (reliability, efficiency & cost-effectiveness, clinical performance, and service & support) and 14 secondary indicators, each with a defined weight. This consensus aims to provide technical guidance for clinicians, direct future research and development for manufacturers, and ultimately promote the widespread adoption of high-quality domestic medical endoscopes, thereby advancing the national medical equipment industry.

1.	中國醫療保健國際交流促進會胸外科分會, 中國抗癌協會肺部腫瘤整合康復專業委員會, 浙江省醫師協會胸外科醫師分會, 等. 4K熒光高端國產醫用內窺鏡全國胸外科臨床應用評價專家共識(2023). 中國胸心血管外科臨床雜志, 2024, 31(3): 337-342.Thoracic Surgery Branch of China International Exchange and Promotion Association for Medical and Healthcare, Integrated Rehabilitation Professional Committee for Lung Cancer of China Anti-Cancer Association, Thoracic Surgeon Branch of Zhejiang Medical Doctor Association, et al. Chinese expert consensus on clinical application evaluation of 4K fluorescence high-end domestic medical endoscopes in thoracic surgery (2023). Chin J Clin Thorac Cardiovasc Surg, 2024, 31(3): 337-342.
2.	張曉斌, 張亞東, 周宇. 4K一體化智能腔鏡系統的探究與應用. 中國醫療設備, 2021, 36(8): 54-57.Zhang XB, Zhang YD, Zhou Y. Exploration and application of 4K integrated intelligent endoscopic system. China Med Devices, 2021, 36(8): 54-57.
3.	Takamori S, Nakatsuka M, Watanabe H, et al. Segmental bronchial marking method using indocyanine green for safe thoracoscopic segmentectomy: a single-center early experience. J Thorac Dis, 2025, 17(5): 2958-2966.
4.	Wang L, Hu J, Gao J, et al. Artificial intelligence-assisted surgical simulation system based on non-enhanced computed tomography images in thoracoscopic pulmonary segmentectomies. J Thorac Dis, 2025, 17(8): 5787-5802.
5.	詹必成, 劉建, 陳劍, 等. 三維重建指導下單孔熒光胸腔鏡肺亞段切除肺結節的療效分析. 中華胸心血管外科雜志, 2024, 40(11): 641-646.Zhan BC, Liu J, Chen J, et al. Efficacy analysis of three-dimensional reconstruction-guided uniportal fluorescent thoracoscopic pulmonary subsegmentectomy for pulmonary nodules. Chin J Thorac Cardiovasc Surg, 2024, 40(11): 641-646.
6.	陳世雄, 陳勝家, 陳愷, 等. 單孔胸腔鏡支氣管袖式肺葉切除術臨床經驗. 中國微創外科雜志, 2022, 22(9): 739-742.Chen SX, Chen SJ, Chen K, et al. Clinical experience with uniportal video-assisted thoracoscopic bronchial sleeve lobectomy. Chin J Minim Invasive Surg, 2022, 22(9): 739-742.
7.	國家藥品監督管理局醫療器械技術審評中心. 醫療器械臨床評價技術指導原則. (2021-04-30)[2024-05-01].Center for Medical Device Evaluation, National Medical Products Administration. Technical guidelines for clinical evaluation of medical devices. (2021-04-30)[2024-05-01].
8.	Cohen D, Cragg M, Gao F, et al. Development of a key performance indicator framework for medical equipment management. J Med Eng Technol, 2019, 43(3): 139-150.
9.	于曉初, 趙韡, 焦亞輝, 等. 大型醫用設備成本效益分析評價體系的構建與研究. 中國醫院, 2016, 20(1): 10-12.Yu XC, Zhao W, Jiao YH, et al. Construction and research of cost-benefit analysis evaluation system for large medical equipment. Chin Hosp, 2016, 20(1): 10-12.
10.	張和華, 尹軍, 魏安海, 等. 基于AHP和德爾菲法的醫療器械臨床使用評價指標體系構建. 中國醫療設備, 2021, 36(3): 120-124.Zhang HH, Yin J, Wei AH, et al. Construction of clinical use evaluation index system for medical devices based on AHP and Delphi method. China Med Devices, 2021, 36(3): 120-124.
11.	Fargen KM, Frei D, Fiorella D, et al. The FDA human factors guidance and neurointerventional devices: what are we supposed to do? J Neurointerv Surg, 2015, 7(9): 646-648.
12.	李輝, 王俊, 劉軍, 等. 國產4K熒光胸腔鏡在單孔肺葉切除術中的應用價值: 一項多中心前瞻性研究. 中華胸心血管外科雜志, 2024, 40(2): 65-70.Li H, Wang J, Liu J, et al. Application value of domestic 4K fluorescent thoracoscopy in uniportal lobectomy: a multicenter prospective study. Chin J Thorac Cardiovasc Surg, 2024, 40(2): 65-70.
13.	桑維淼, 張帥. 基于多源數據分析的醫療設備異常運行狀態監測方法研究. 中國醫療設備, 2025, 40(9): 45-50. DOI: CNKI:SUN:YLSX.0.2025-09-008.Sang WM, Zhang S. Research on monitoring method for abnormal operation status of medical equipment based on multi-source data analysis. China Med Devices, 2025, 40(9): 45-50. DOI: CNKI:SUN:YLSX.0.2025-09-008.
14.	馮罕博, 楊錫婷, 莫兆雯. 醫院醫療器械不良事件管理實踐探討. 中國醫療器械信息, 2023, 29(23): 58-60.Feng HB, Yang XT, Mo ZW. Discussion on the management practice of adverse events of medical devices. Chin Med Device Inf, 2023, 29(23): 58-60.
15.	王豐. 真實世界研究在醫療器械全生命周期中的應用. 醫療裝備, 2023, 36(3): 24-28.Wang F. Application of real-world study in the full life cycle of medical devices. Med Equip, 2023, 36(3): 24-28.
16.	商樸, 單彬, 段麗娟, 等. 醫療器械臨床試驗綜合評價指標體系的構建. 中國醫療設備, 2024, 39(9): 119-124.Shang P, Shan B, Duan LJ, et al. Construction of comprehensive evaluation index system for clinical trial of medical devices. China Med Devices, 2024, 39(9): 119-124.

1. 中國醫療保健國際交流促進會胸外科分會, 中國抗癌協會肺部腫瘤整合康復專業委員會, 浙江省醫師協會胸外科醫師分會, 等. 4K熒光高端國產醫用內窺鏡全國胸外科臨床應用評價專家共識(2023). 中國胸心血管外科臨床雜志, 2024, 31(3): 337-342.Thoracic Surgery Branch of China International Exchange and Promotion Association for Medical and Healthcare, Integrated Rehabilitation Professional Committee for Lung Cancer of China Anti-Cancer Association, Thoracic Surgeon Branch of Zhejiang Medical Doctor Association, et al. Chinese expert consensus on clinical application evaluation of 4K fluorescence high-end domestic medical endoscopes in thoracic surgery (2023). Chin J Clin Thorac Cardiovasc Surg, 2024, 31(3): 337-342.
2. 張曉斌, 張亞東, 周宇. 4K一體化智能腔鏡系統的探究與應用. 中國醫療設備, 2021, 36(8): 54-57.Zhang XB, Zhang YD, Zhou Y. Exploration and application of 4K integrated intelligent endoscopic system. China Med Devices, 2021, 36(8): 54-57.
3. Takamori S, Nakatsuka M, Watanabe H, et al. Segmental bronchial marking method using indocyanine green for safe thoracoscopic segmentectomy: a single-center early experience. J Thorac Dis, 2025, 17(5): 2958-2966.
4. Wang L, Hu J, Gao J, et al. Artificial intelligence-assisted surgical simulation system based on non-enhanced computed tomography images in thoracoscopic pulmonary segmentectomies. J Thorac Dis, 2025, 17(8): 5787-5802.
5. 詹必成, 劉建, 陳劍, 等. 三維重建指導下單孔熒光胸腔鏡肺亞段切除肺結節的療效分析. 中華胸心血管外科雜志, 2024, 40(11): 641-646.Zhan BC, Liu J, Chen J, et al. Efficacy analysis of three-dimensional reconstruction-guided uniportal fluorescent thoracoscopic pulmonary subsegmentectomy for pulmonary nodules. Chin J Thorac Cardiovasc Surg, 2024, 40(11): 641-646.
6. 陳世雄, 陳勝家, 陳愷, 等. 單孔胸腔鏡支氣管袖式肺葉切除術臨床經驗. 中國微創外科雜志, 2022, 22(9): 739-742.Chen SX, Chen SJ, Chen K, et al. Clinical experience with uniportal video-assisted thoracoscopic bronchial sleeve lobectomy. Chin J Minim Invasive Surg, 2022, 22(9): 739-742.
7. 國家藥品監督管理局醫療器械技術審評中心. 醫療器械臨床評價技術指導原則. (2021-04-30)[2024-05-01].Center for Medical Device Evaluation, National Medical Products Administration. Technical guidelines for clinical evaluation of medical devices. (2021-04-30)[2024-05-01].
8. Cohen D, Cragg M, Gao F, et al. Development of a key performance indicator framework for medical equipment management. J Med Eng Technol, 2019, 43(3): 139-150.
9. 于曉初, 趙韡, 焦亞輝, 等. 大型醫用設備成本效益分析評價體系的構建與研究. 中國醫院, 2016, 20(1): 10-12.Yu XC, Zhao W, Jiao YH, et al. Construction and research of cost-benefit analysis evaluation system for large medical equipment. Chin Hosp, 2016, 20(1): 10-12.
10. 張和華, 尹軍, 魏安海, 等. 基于AHP和德爾菲法的醫療器械臨床使用評價指標體系構建. 中國醫療設備, 2021, 36(3): 120-124.Zhang HH, Yin J, Wei AH, et al. Construction of clinical use evaluation index system for medical devices based on AHP and Delphi method. China Med Devices, 2021, 36(3): 120-124.
11. Fargen KM, Frei D, Fiorella D, et al. The FDA human factors guidance and neurointerventional devices: what are we supposed to do? J Neurointerv Surg, 2015, 7(9): 646-648.
12. 李輝, 王俊, 劉軍, 等. 國產4K熒光胸腔鏡在單孔肺葉切除術中的應用價值: 一項多中心前瞻性研究. 中華胸心血管外科雜志, 2024, 40(2): 65-70.Li H, Wang J, Liu J, et al. Application value of domestic 4K fluorescent thoracoscopy in uniportal lobectomy: a multicenter prospective study. Chin J Thorac Cardiovasc Surg, 2024, 40(2): 65-70.
13. 桑維淼, 張帥. 基于多源數據分析的醫療設備異常運行狀態監測方法研究. 中國醫療設備, 2025, 40(9): 45-50. DOI: CNKI:SUN:YLSX.0.2025-09-008.Sang WM, Zhang S. Research on monitoring method for abnormal operation status of medical equipment based on multi-source data analysis. China Med Devices, 2025, 40(9): 45-50. DOI: CNKI:SUN:YLSX.0.2025-09-008.
14. 馮罕博, 楊錫婷, 莫兆雯. 醫院醫療器械不良事件管理實踐探討. 中國醫療器械信息, 2023, 29(23): 58-60.Feng HB, Yang XT, Mo ZW. Discussion on the management practice of adverse events of medical devices. Chin Med Device Inf, 2023, 29(23): 58-60.
15. 王豐. 真實世界研究在醫療器械全生命周期中的應用. 醫療裝備, 2023, 36(3): 24-28.Wang F. Application of real-world study in the full life cycle of medical devices. Med Equip, 2023, 36(3): 24-28.
16. 商樸, 單彬, 段麗娟, 等. 醫療器械臨床試驗綜合評價指標體系的構建. 中國醫療設備, 2024, 39(9): 119-124.Shang P, Shan B, Duan LJ, et al. Construction of comprehensive evaluation index system for clinical trial of medical devices. China Med Devices, 2024, 39(9): 119-124.

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Latest ArticlesExpert consensus on evaluation indicators for the application of domestic high-end thoracoscopic thoracic surgery

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