In recent years,robot-assisted technology has become increasingly sophisticated in the field of orthopedic surgical navigation.To ensure surgical safety and protect patient rights,corresponding products must undergo rigorous and standardized pre-market quality evaluations.In 2023,the National Medical Products Administration issued the sectoral standard YY/T 1901-2023 Requirements and Test Methods for Orthopaedic Surgical Navigation Equipment Employing Robotic Technology.This standard specifies the performance require-ments for robotic orthopedic surgical navigation systems across ten key aspects:general requirements,robotic arm positioning device performance,tracking device performance,system performance,installation repeatability,protective functions,orthopedic powered surgical instruments,liquid cooling,positioning acces-sory requirements,and software requirements.Additionally,it standardizes quality evaluation methods,provi-ding significant guidance for advancing robotic technology,accelerating product market entry,and strengthe-ning regulatory oversight.This article analyzes the key components of the standard to facilitate better quality assessment of products and promote high-quality development within the industry.

In recent years,with the rapid development of the artificial intelligence(AI)medical device industry,regulatory authorities have been continuously strengthening quality control over datasets.In 2024,the National Medical Products Administration(NMPA)issued the significant industry standard YY/T 1949-2024 Artificial Intelligence Medical Devices—Particular Requirements for Datasets:Color Fundus Photographs of Dia-betic Retinopathy,which is China's first specialized standard for evaluating dataset quality in AI medical devices targeting a specific disease area.Under the existing general standards framework for AI medical devices,this standard focuses specifically on diabetic retinopathy fundus photograph datasets,systematically proposing spe-cialized quality requirements and testing methods.Its implementation will provide clear technical guidance for dataset manufacturers,help improve the development quality of AI-assisted diagnostic software for diabetic retinopathy,and promote standardized industry advancement.

Objective To observe the value of CT angiography(CTA)for classifying type of peripheral arteriovenous fistula(AVF)in children.Methods Totally 22 children with peripheral AVF were retrospectively enrolled,the type of AVF was classified with preoperative CTA,and therapeutic planning was developed.Taken digital subtraction angiography(DSA)findings during interventional therapy as gold standards,the efficacy of CTA for classifying type of AVF was analyzed.Results Among 22 cases,DSA detected 3 cases of type Ⅰ,13 cases of type Ⅱa and 6 cases of typeⅡb peripheral AVF,while 3 cases of type Ⅰ,14 cases of type Ⅱa and 5 cases of type Ⅱb peripheral AVF were classified based on CTA.CTA misdiagnosed 1 case of type Ⅱa as type Ⅱb,and 2 cases of type Ⅱb as type Ⅱa peripheral AVF,its accuracy of CTA for classifying type Ⅰ,Ⅱa and Ⅱb peripheral AVF was 100%(3/3),92.31%(12/13)and 66.67%(4/6),respectively.Among 22 cases,13 cases underwent interventional closure,2 cases underwent interventional therapy combined with surgery,while 3 cases did not receive relevant treatment due to drainage vein occlusion.One month after treatments,the symptoms of 19 cases who underwent treatment improved significantly,and no signs of AVF was found with re-examination of ultrasound nor CTA.Conclusion CTA was helpful to classifying type of peripheral AV in children,which could provide references for interventional therapy.

In recent years,robot-assisted technology has become increasingly sophisticated in the field of orthopedic surgical navigation.To ensure surgical safety and protect patient rights,corresponding products must undergo rigorous and standardized pre-market quality evaluations.In 2023,the National Medical Products Administration issued the sectoral standard YY/T 1901-2023 Requirements and Test Methods for Orthopaedic Surgical Navigation Equipment Employing Robotic Technology.This standard specifies the performance require-ments for robotic orthopedic surgical navigation systems across ten key aspects:general requirements,robotic arm positioning device performance,tracking device performance,system performance,installation repeatability,protective functions,orthopedic powered surgical instruments,liquid cooling,positioning acces-sory requirements,and software requirements.Additionally,it standardizes quality evaluation methods,provi-ding significant guidance for advancing robotic technology,accelerating product market entry,and strengthe-ning regulatory oversight.This article analyzes the key components of the standard to facilitate better quality assessment of products and promote high-quality development within the industry.

In recent years,with the rapid development of the artificial intelligence(AI)medical device industry,regulatory authorities have been continuously strengthening quality control over datasets.In 2024,the National Medical Products Administration(NMPA)issued the significant industry standard YY/T 1949-2024 Artificial Intelligence Medical Devices—Particular Requirements for Datasets:Color Fundus Photographs of Dia-betic Retinopathy,which is China's first specialized standard for evaluating dataset quality in AI medical devices targeting a specific disease area.Under the existing general standards framework for AI medical devices,this standard focuses specifically on diabetic retinopathy fundus photograph datasets,systematically proposing spe-cialized quality requirements and testing methods.Its implementation will provide clear technical guidance for dataset manufacturers,help improve the development quality of AI-assisted diagnostic software for diabetic retinopathy,and promote standardized industry advancement.

Objective To observe the value of CT angiography(CTA)for classifying type of peripheral arteriovenous fistula(AVF)in children.Methods Totally 22 children with peripheral AVF were retrospectively enrolled,the type of AVF was classified with preoperative CTA,and therapeutic planning was developed.Taken digital subtraction angiography(DSA)findings during interventional therapy as gold standards,the efficacy of CTA for classifying type of AVF was analyzed.Results Among 22 cases,DSA detected 3 cases of type Ⅰ,13 cases of type Ⅱa and 6 cases of typeⅡb peripheral AVF,while 3 cases of type Ⅰ,14 cases of type Ⅱa and 5 cases of type Ⅱb peripheral AVF were classified based on CTA.CTA misdiagnosed 1 case of type Ⅱa as type Ⅱb,and 2 cases of type Ⅱb as type Ⅱa peripheral AVF,its accuracy of CTA for classifying type Ⅰ,Ⅱa and Ⅱb peripheral AVF was 100%(3/3),92.31%(12/13)and 66.67%(4/6),respectively.Among 22 cases,13 cases underwent interventional closure,2 cases underwent interventional therapy combined with surgery,while 3 cases did not receive relevant treatment due to drainage vein occlusion.One month after treatments,the symptoms of 19 cases who underwent treatment improved significantly,and no signs of AVF was found with re-examination of ultrasound nor CTA.Conclusion CTA was helpful to classifying type of peripheral AV in children,which could provide references for interventional therapy.

Objective:To clarify the content on exercise training in patients with connective tissue disease-associated pulmonary arterial hypertension through a scoping review.Methods:Using the scoping review methodological framework proposed by Arksey and O'Malley as a guide, Chinese and English databases such as PubMed, Embase, Wanfang Data, and China National Knowledge Infrastructure were searched to screen the literature on exercise training for patients with connective tissue disease-associated pulmonary arterial hypertension. The search period was from database establishment to April 30, 2024. Two researchers extracted basic information of the included literature, content of the pre-exercise training assessment, exercise training program, and outcome indicators.Results:A total of 13 articles were included. The content of the pre-exercise training assessment in patients with connective tissue disease-associated pulmonary arterial hypertension was not standardized. The type of exercise training was based on aerobic, resistance and respiratory training, with a focus on home exercise. The main outcome indicators included the 6-minute walk distance, cardiopulmonary function, quality of life, and muscle strength.Conclusions:There are various types of exercise training for patients with connective tissue disease-associated pulmonary arterial hypertension, which are safe and feasible. Future research should focus on conducting home-based exercise training programs and constructing core outcome indicators to assess the effectiveness of exercise training.

With the widespread application of robotic technology in surgery, multiple robot-assisted laparoscopic endoscopic surgical systems are currently in the R&D phase, highlighting an urgent need for establishing a scientific and standardized quality evaluation framework. In 2024, the National Medical Products Administration issued the standard YY/T 1941-2024, entitled Robotically-assisted Laparoscopic Surgical System, which specifies performance requirements and test methods for such systems. This standard provides critical guidance for the development of innovative products, technological advancement, and regulatory oversight. The standard offers clear definitions of relevant terminology and systematically standardizes the quality evaluation methods for these products across six key aspects: manual controller performance, instrument arm performance, system operational performance, safety protection functions, robotic surgical instruments, and software. This article interprets the core indicators outlined in the standard, aiming to assist clinicians in gaining a deeper understanding of the performance parameters of these systems and to support manufacturers in conducting quality assessments and risk analyses during product development, thereby promoting high-quality progress in the industry and related products.

Objective:To study the protective effect of Pien-Tze-Huang on acetaminophen-induced liver injury,and to clarify the possible mechanism.Methods:The human normal hepatocytes(L02 cells)were divided into control group,APAP group(10 mmol·L-1 APAP),APAP+PZH group(10 mmol·L-1 APAP and 0.4 mg·mL-1 PZH),and PZH group(0.4 mg·mL-1 PZH).The survival rates of the cells in various groups were determined by MTT method,the morphology was observed by inverted microscope,and the apoptotic rates were detected by flow cytometry.The activities of superoxide dismutase(SOD)and lactate dehydrogenase(LDH)and the levels of malondialdehyde(MDA)in the cell supernant in various groups were detected by the kits,the reactive oxygen species(ROS)levels and the mitochondrial membrane potential(MMP)in the hepatocytes in various groups were detected by fluorescence probe.Western blotting method was used to examine the expression levels of apoptosis-related proteins,phosphatidylinositol 3 kinase(PI3K)/protein kinase B(AKT)signaling pathway proteins,nuclear factor-κB(NF-κB)signaling pathway proteins and inflammatory factors in the cells in various groups.Results:The results of MTT showed that compared with control group,the survival rate of the cells in APAP group was markedly decreased(P＜0.05);compared with APAP group,the survival rate of the cells in APAP+PZH group was significantly increased(P＜0.05).Compared with control group,the number of the L02 cells in APAP group showed a decreasing and loosely arranged trend;compared with APAP group,the number and arrangement of the L02 cells in APAP+PZH group were notably improved.The results of flow cytometry showed that compared with control group,the apoptotic rate of the L02 cells in APAP group was significantly increased(P＜0.05);compared with APAP group,the apoptotic rate of the cells in APAP+PZH group was significantly decreased(P＜0.05).Compared with control group,the activity of LDH and level of MDA in the cells in APAP group were significantly increased(P＜0.05),while the activity of SOD was significantly decreased(P＜0.05);compared with APAP group,the activity of LDH and level of MDA in the cells in APAP+PZH group were significantly decreased(P＜0.05),while the activity of SOD was significantly increased(P＜0.05).Compared with control group,the fluorescence intensity of ROS in the cells in APAP group was significantly increased;compared with APAP group,the fluorescence intensity of ROS in APAP+PZH group was significantly decreased.Compared with control group,the MMP of the L02 cells in APAP group was significantly decreased;compared with APAP group,the MMP of the L02 cells in APAP+PZH group was significantly increased.The results of Western blotting showed that compared with control group,the expression levels of caspase-9,B-cell lymphoma 2(Bcl-2)associated X protein(BAX),phosphorylated PI3K(p-PI3K),phosphorylated AKT(p-AKT),phosphorylated NF-κB inhibitor alpha(p-IKBα),p-P65,phosphorylated inhibitor of kappaB kinaseβ(p-IKKβ),interleukin-1β(IL-1β),interleukin-6(IL-6),and tumor necrosis factor-α(TNF-α)proteins in the cells in APAP group were significantly increased(P＜0.05),while the level of Bcl-2 proteins in the cells in APAP group was significantly decreased(P＜0.05);compared with APAP group,the levels of caspase-3,BAX,p-PI3K,p-AKT,p-IKBα,p-P65,p-IKKβ,IL-1β,IL-6,and TNF-α proteins in the cells in APAP+PZH group were significantly decreased,while the level of Bcl-2 protein was significantly increased(P＜0.05).Conclusion:PZH may reduce the oxidative stress and inflammatory response in the cells by regulating the PI3K/AKT and NF-κB signaling pathway,therefore attenuate the L02 cell injury induced by APAP.

Objective:To evaluate the design methodology and efficacy of skin excision in sitting and supine positions of blepharoplasty.Methods:A retrospective study was performed on 31 female patients who received double eyelid surgery at the Department of Plastic and Aesthetic Surgery, Affiliated Hospital of Qingdao University, from January to June 2021. The patients ′ ages varied from 18 to 37 years, with a mean age of (26.5±5.2) years. Of the patients, 27 exhibited single eyelids, while 4 presented with shallow double eyelids. All patients demonstrated laxity of the upper eyelid skin. The method of utilizing the sitting and supine positions was employed to determine the extent of skin excision, subsequently leading to full-incision double eyelid surgery. Follow-up was performed through clinic visits and WeChat to monitor double eyelid morphology, complications, and evaluate patient satisfaction. Results:All 31 patients successfully underwent the surgical procedure. Postoperative follow-up duration varied from 3 to 12 months. The double eyelid lines manifested as natural and seamless, with suitable width. All patients exhibited satisfactory eyelid closure, with no instances of ectropion or incomplete eyelid closure. Skin laxity of the upper eyelid was significantly ameliorated in all instances. The patient satisfaction rate was 100% (31/31).Conclusions:The sitting and supine position for executing skin excision in double eyelid surgery is straight forward to implement. Postoperative outcomes demonstrate natural and seamless double eyelid contours, with adequate rectification of upper eyelid skin laxity.