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.	中国医疗保健国际交流促进会胸外科分会, 中国抗癌协会肺部肿瘤整合康复专业委员会, 浙江省医师协会胸外科医师分会, 等. 4K荧光高端国产医用内窥镜全国胸外科临床应用评价专家共识(2023). 中国胸心血管外科临床杂志, 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.	张晓斌, 张亚东, 周宇. 4K一体化智能腔镜系统的探究与应用. 中国医疗设备, 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, 刘建, 陈剑, 等. 三维重建指导下单孔荧光胸腔镜肺亚段切除肺结节的疗效分析. 中华胸心血管外科杂志, 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.	陈世雄, 陈胜家, 陈恺, 等. 单孔胸腔镜支气管袖式肺叶切除术临床经验. 中国微创外科杂志, 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.	国家药品监督管理局医疗器械技术审评中心. 医疗器械临床评价技术指导原则. (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.	于晓初, 赵韡, 焦亚辉, 等. 大型医用设备成本效益分析评价体系的构建与研究. 中国医院, 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.	张和华, 尹军, 魏安海, 等. 基于AHP和德尔菲法的医疗器械临床使用评价指标体系构建. 中国医疗设备, 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.	李辉, 王俊, 刘军, 等. 国产4K荧光胸腔镜在单孔肺叶切除术中的应用价值: 一项多中心前瞻性研究. 中华胸心血管外科杂志, 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.	桑维淼, 张帅. 基于多源数据分析的医疗设备异常运行状态监测方法研究. 中国医疗设备, 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.	冯罕博, 杨锡婷, 莫兆雯. 医院医疗器械不良事件管理实践探讨. 中国医疗器械信息, 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.	王丰. 真实世界研究在医疗器械全生命周期中的应用. 医疗装备, 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.	商朴, 单彬, 段丽娟, 等. 医疗器械临床试验综合评价指标体系的构建. 中国医疗设备, 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. 中国医疗保健国际交流促进会胸外科分会, 中国抗癌协会肺部肿瘤整合康复专业委员会, 浙江省医师协会胸外科医师分会, 等. 4K荧光高端国产医用内窥镜全国胸外科临床应用评价专家共识(2023). 中国胸心血管外科临床杂志, 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. 张晓斌, 张亚东, 周宇. 4K一体化智能腔镜系统的探究与应用. 中国医疗设备, 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, 刘建, 陈剑, 等. 三维重建指导下单孔荧光胸腔镜肺亚段切除肺结节的疗效分析. 中华胸心血管外科杂志, 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. 陈世雄, 陈胜家, 陈恺, 等. 单孔胸腔镜支气管袖式肺叶切除术临床经验. 中国微创外科杂志, 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. 国家药品监督管理局医疗器械技术审评中心. 医疗器械临床评价技术指导原则. (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. 于晓初, 赵韡, 焦亚辉, 等. 大型医用设备成本效益分析评价体系的构建与研究. 中国医院, 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. 张和华, 尹军, 魏安海, 等. 基于AHP和德尔菲法的医疗器械临床使用评价指标体系构建. 中国医疗设备, 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. 李辉, 王俊, 刘军, 等. 国产4K荧光胸腔镜在单孔肺叶切除术中的应用价值: 一项多中心前瞻性研究. 中华胸心血管外科杂志, 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. 桑维淼, 张帅. 基于多源数据分析的医疗设备异常运行状态监测方法研究. 中国医疗设备, 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. 冯罕博, 杨锡婷, 莫兆雯. 医院医疗器械不良事件管理实践探讨. 中国医疗器械信息, 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. 王丰. 真实世界研究在医疗器械全生命周期中的应用. 医疗装备, 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. 商朴, 单彬, 段丽娟, 等. 医疗器械临床试验综合评价指标体系的构建. 中国医疗设备, 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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