• 대한의용생체공학회:의공학회지
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• 제44권3호
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• pp.204-210
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• 2023

This study focuses on analyzing medical device standards and regulatory requirements in the medical device industry, based on the Medical Device Act in Korea. The objective of this analysis is to determine whether the domestic standards for medical devices in Korea align with international and regional standards. Furthermore, it aims to identify the current application of domestic standards in ensuring the safety and essential performance of medical devices. The analysis revealed that out of a total of 281 domestic standards, 127 standards reference international standards. In terms of the application of domestic standards to specific items, there were 473 types of instruments/machines, 30 types of medical supplies, and 45 types of dental materials. However, the level of compliance with international standards among the domestic medical device standards was only 21%. Upon detailed analysis, general and collateral standards accounted for 24%, while particular standards accounted for 19%. This indicates a significant deviation from the latest international standards. On the other hand, the level of compliance with international standards was analyzed to be 60% for particular standards and 72% for general and collateral standards in Korean industrial standards (KS). Considering these results, the disparities between domestic standards and international standards underscore the need for discussions on domestic medical device regulation and standardization. In conclusion, this study emphasizes the significance of maintaining up-to-date medical device standards and ensuring their alignment with international standards to ensure the safety and quality of medical devices. The findings highlight the necessity for further efforts to strengthen the domestic standardization system in order to promote the development of safe and high-quality medical devices.

• Korean Journal of Radiology
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• 제22권12호
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• pp.2026-2033
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• 2021

Objective: The aim of this study was to compare the diagnostic performances of digital tomosynthesis (DTS) and conventional radiography in detecting osteonecrosis of the femoral head (ONFH) using computed tomography (CT), as the reference standard and evaluate the diagnostic reproducibility of DTS. Materials and Methods: Forty-five patients (24 male and 21 female; age range, 25-77 years) with clinically suspected ONFH underwent anteroposterior radiography, DTS, and CT. Two musculoskeletal radiologists independently evaluated the presence and type of ONFH. The diagnostic performance of radiography and DTS in detecting the presence of ONFH and determining the types of ONFH were evaluated. The interobserver and intraobserver reliabilities of each imaging modality were analyzed using Cohen's kappa. Results: DTS had higher sensitivity (89.4%-100% vs. 74.5%-76.6%) and specificity (97.3%-100% vs. 78.4%-83.8%) for ONFH detection than radiography. DTS showed higher performance than radiography in identifying the subtypes of ONFH with statistical significance in one reader (type 1, 100% vs. 30.8%, p = 0.004; type II, 97.1% vs. 73.5%, p = 0.008). The interobserver agreement was excellent for DTS and moderate for radiography (kappa of 0.86 vs. 0.57, respectively). The intraobserver agreement for DTS was higher than that of radiography (kappa of 0.96 vs. 0.69, respectively). Conclusion: DTS showed higher diagnostic performance and reproducibility than radiography in detecting ONFH. DTS may be used as a first-line diagnostic modality instead of radiography for patients suspected of having ONFH.

• Korean Journal of Radiology
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• 제22권8호
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• pp.1300-1309
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• 2021

Objective: To assess the feasibility and reproducibility of pancreatic surface lobularity (PSL) quantification derived from abdominal computed tomography (CT) in a population of patients free from pancreatic disease. Materials and Methods: This retrospective study included 265 patients free from pancreatic disease who underwent contrast-enhanced abdominal CT between 2017 and 2019. A maximum of 11 individual PSL measurements were performed by two abdominal radiologists (head [5 measurements], body, and tail [3 measurements each]) using dedicated software. The influence of age, body mass index (BMI), and sex on PSL was assessed using the Pearson correlation and repeated measurements. Inter-reader agreement was assessed using the intraclass correlation coefficient (ICC) and Bland Altman (BA) plots. Results: CT images of 15 (6%) patients could not be analyzed. A total of 2750 measurements were performed in the remaining 250 patients (143 male [57%], mean age 45 years [range, 18-91]), and 2237 (81%) values were obtained in the head 951/1250 (76%), body 609/750 (81%), and tail 677/750 (90%). The mean ± standard deviation PSL was 6.53 ± 1.37. The mean PSL was significantly higher in male than in female (6.89 ± 1.30 vs. 6.06 ± 1.31, respectively, p < 0.001). PSL gradually increased with age (r = 0.32, p < 0.001) and BMI (r = 0.32, p < 0.001). Inter-reader agreement was excellent (ICC 0.82 [95% confidence interval 0.72-0.85], with a BA bias of 0.30 and 95% limits of agreement of -1.29 and 1.89). Conclusion: CT-based PSL quantification is feasible with a high success rate and inter-reader agreement in subjects free from pancreatic disease. Significant variations were observed according to sex, age, and BMI. This study provides a reference for future studies.

• Korean Journal of Radiology
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• 제21권4호
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• pp.450-461
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• 2020

Objective: We performed a meta-analysis to evaluate the agreement of cardiac computed tomography (CT) with cardiac magnetic resonance imaging (CMRI) in the assessment of right ventricle (RV) volume and functional parameters. Materials and Methods: PubMed, EMBASE, and Cochrane library were systematically searched for studies that compared CT with CMRI as the reference standard for measurement of the following RV parameters: end-diastolic volume (EDV), end-systolic volume (ESV), stroke volume (SV), or ejection fraction (EF). Meta-analytic methods were utilized to determine the pooled weighted bias, limits of agreement (LOA), and correlation coefficient (r) between CT and CMRI. Heterogeneity was also assessed. Subgroup analyses were performed based on the probable factors affecting measurement of RV volume: CT contrast protocol, number of CT slices, CT reconstruction interval, CT volumetry, and segmentation methods. Results: A total of 766 patients from 20 studies were included. Pooled bias and LOA were 3.1 mL (-5.7 to 11.8 mL), 3.6 mL (-4.0 to 11.2 mL), -0.4 mL (5.7 to 5.0 mL), and -1.8% (-5.7 to 2.2%) for EDV, ESV, SV, and EF, respectively. Pooled correlation coefficients were very strong for the RV parameters (r = 0.87-0.93). Heterogeneity was observed in the studies (I² > 50%, p < 0.1). In the subgroup analysis, an RV-dedicated contrast protocol, ≥ 64 CT slices, CT volumetry with the Simpson's method, and inclusion of the papillary muscle and trabeculation had a lower pooled bias and narrower LOA. Conclusion: Cardiac CT accurately measures RV volume and function, with an acceptable range of bias and LOA and strong correlation with CMRI findings. The RV-dedicated CT contrast protocol, ≥ 64 CT slices, and use of the same CT volumetry method as CMRI can improve agreement with CMRI.

• Steel and Composite Structures
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• 제50권4호
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• pp.383-401
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• 2024

The research comprehensively studies the axial compression performance of T-shaped concrete-filled thin-walled steel tubular (CTST) long columns after fire exposure. Initially, a series of tests investigate the effects of heating time, load eccentricity, and stiffeners on the column's performance. Furthermore, Finite Element (FE) analysis is employed to establish temperature and mechanical field models for the T-shaped CTST long column with stiffeners after fire exposure, using carefully determined key parameters such as thermal parameters, constitutive relations, and contact models. In addition, a parametric analysis based on the numerical models is conducted to explore the effects of heating time, section diameter, material strength, and steel ratio on the axial compressive bearing capacity, bending bearing capacity under normal temperature, as well as residual bearing capacity after fire exposure. The results reveal that the maximum lateral deformation occurs near the middle of the span, with bending increasing as heating time and eccentricity rise. Despite a decrease in axial compressive load and bending capacity after fire exposure, the columns still exhibit desirable bearing capacity and deformability. Moreover, the obtained FE results align closely with experimental findings, validating the reliability of the developed numerical models. Additionally, this study proposes a simplified design method to calculate these mechanical property parameters, satisfying the ISO-834 standard. The relative errors between the proposed simplified formulas and FE models remain within 10%, indicating their capability to provide a theoretical reference for practical engineering applications.

• Korean Journal of Radiology
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• 제23권8호
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• pp.803-810
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• 2022

Objective: To investigate the clinical application of differential subsampling with Cartesian ordering (DISCO) contrast-enhanced (CE) magnetic resonance angiography for anterolateral thigh (ALT) flap transplantation, using operative findings as a reference. Materials and Methods: Thirty patients (21 males and nine females; mean age ± standard deviation, 45.5 ± 15.6 years) who were scheduled to undergo reconstruction with ALT flaps between June 2020 and June 2021 were included in the prospective study. Before ALT flap transplantation, patients were scanned using CE-DISCO imaging. All acquired DISCO images of the 60 lower limbs (both sides from each patient) were analyzed using maximum intensity projection and volume rendering methods. Two experienced radiologists were employed to examine the patterns of the lateral circumflex femoral artery (LCFA), its branches, and perforators and their skin termini, which were compared with the operative findings. Results: Using CE-DISCO, the patterns of the LCFA and its branches were clearly identified in all patients. Four different origins of the LCFA were found among the 60 blood vessels: type I (44/60, 73.3%), type II (6/60, 10.0%), type III (8/60, 13.3%), and type IV (2/60, 3.3%). Owing to a lack of perforators entering the skin, two patients did not undergo ALT flap transplantation. For the remaining 28 patients, the ALT flaps in 26 patients were successfully operated without flap reselection during the operation, while the remaining two patients underwent other surgical procedures due to the thin diameter of the perforator or injury of the perforator during the operation. The success rate of flap transplantation was 92.8% (26/28). All transplanted flaps exhibited good blood supply and achieved primary healing without infection or delayed healing. Conclusion: CE-DISCO imaging can be an effective method for preoperative perforator imaging before ALT flap transplantation.

• Korean Journal of Radiology
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• 제23권4호
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• pp.479-487
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• 2022

Objective: To prospectively evaluate the efficacy of lauromacrogol injection for ablation (LIA) of benign predominantly cystic thyroid nodules and its related factors. Materials and Methods: A total of 142 benign predominantly cystic thyroid nodules (median volume, 12.5 mL; range, 0.4-156 mL) in 137 patients (male:female sex ratio, 36:101; mean age ± standard deviation [SD], 49 ± 13 years) were treated with LIA after being confirmed as benign via cytology. The volume reduction rate (VRR) of the nodules and cosmetic score were evaluated during follow-up at 1, 3, and 6 months after treatment and every 6 months thereafter. A VRR of ≥ 50% at the 12-month follow-up was considered to indicate effective treatment. The associations between the clinical factors and nodular ultrasound features, including the initial nodule volume, proportion of solid components, vascularity grade and ineffective treatment (VRR of < 50% at the 12-month follow-up), and regrowth were analyzed. Results: All patients completed follow-up for at least 12 months. The average ± SD follow-up period was 32 ± 11 months (range, 12-54 months). The effective treatment rate was 73.2% (104/142), while the regrowth rate was 12.0% (17/142) at the last follow-up. Grade 2-3 intranodular vascularity in the solid components of the nodules was the only independent factor associated with ineffective treatment, with an odds ratio (reference category, grade 0-1) of 3.054 (95% confidence interval, 1.148-8.127) (p = 0.025). Conclusion: LIA is an effective treatment for predominantly cystic thyroid nodules. Grade 2-3 intranodular vascularity in the solid components of nodules is the only independent risk factor for ineffective LIA.

• Korean Journal of Radiology
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• 제2권4호
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• pp.210-215
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• 2001

Objective: To investigate the efficacy of gadobenate dimeglumine (GdBOPTA) enhanced MR imaging for the detection of liver lesions in patients with primary malignant hepatic neoplasms. Materials and Methods: Thirty-one patients with histologically proven primary malignancy of the liver were evaluated before and after administration of GdBOPTA at dose 0.05 or 0.10 mmol/kg. T1-weighted spin echo (T1W-SE) and gradient echo (T1W-GRE) images were evaluated for lesion number, location, size and confidence by three off-site independent reviewers and the findings were compared to reference standard imaging (intraoperative ultrasound, computed tomography during arterial portography or lipiodol computed tomography). Results were analyzed for significance using a two-sided McNemar's test. Results: More lesions were identified on Gd-BOPTA enhanced images than on unenhanced images and there was no significant difference in lesion detection between either concentration. The largest benefit was in detection of lesions under 1 cm in size (7 to 21, 9 to 15, 16 to 18 for reviewers A, B, C respectively). In 68% of the patients with more than one lesion, Gd-BOPTA increased the number of lesions detected. Conclusion: Liver MR imaging after Gd-BOPTA increases the detection of liver lesions in patients with primary malignant hepatic neoplasm.

• Korean Journal of Radiology
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• 제21권6호
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• pp.684-694
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• 2020

Objective: The purpose was to review the diagnostic performance of the length of tumor capsular contact (LCC) on magnetic resonance imaging (MRI) for detecting prostate cancer extraprostatic extension (EPE). Materials and Methods: PubMed and EMBASE databases were searched up to March 24, 2019. We included diagnostic accuracy studies that evaluated LCC on MRI for EPE detection using radical prostatectomy specimen histopathology as the reference standard. Quality of studies was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. Sensitivity and specificity were pooled and graphically presented using hierarchical summary receiver operating characteristic (HSROC) plots. Meta-regression and subgroup analyses were conducted to explore heterogeneity. Results: Thirteen articles with 2136 patients were included. Study quality was generally good. Summary sensitivity and specificity were 0.79 (95% confidence interval [CI] 0.73-0.83) and 0.67 (95% CI 0.60-0.74), respectively. Area under the HSROC was 0.81 (95% CI 0.77-0.84). Substantial heterogeneity was present among the included studies according to Cochran's Q-test (p < 0.01) and Higgins I² (62% and 86% for sensitivity and specificity, respectively). In terms of heterogeneity, measurement method (curvilinear vs. linear), prevalence of Gleason score ≥ 7, MRI readers' experience, and endorectal coils were significant factors (p ≤ 0.01), whereas method to determine the LCC threshold, cutoff value, magnet strength, and publication year were not (p = 0.14-0.93). Diagnostic test accuracy estimates were comparable across all assessed MRI sequences. Conclusion: Greater LCC on MRI is associated with a higher probability of prostate cancer EPE. Due to heterogeneity among the studies, further investigation is needed to establish the optimal cutoff value for each clinical setting.

• Journal of the Korean Wood Science and Technology
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• 제44권1호
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• pp.75-84
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• 2016

건물에너지 저감에 효과적으로 기여하는 건축 재료를 이용하는 목조주택을 기반으로 단열 성능이 향상되고 있다. 그러나 고단열 고기밀화로 인한 습기 제어가 어려워져 외벽의 결로 및 곰팡이 발생으로 인하여 성능이 저하될 수 있다. 이에 열 습기 시뮬레이션 프로그램을 이용하여 선정한 5가지 형태의 목조주택 외벽의 열 습기 성능, 결로 발생 및 곰팡이 성장 위험을 평가하였다. 목조주택은 농촌주택 표준설계도 '10과 '14, $2^{{\prime}{\prime}}{\times}6^{{\prime}{\prime}}$형, EIFS 그리고 목조형 패시브 하우스로 선정하였고, 각 벽체 레이어를 구성에 따라 벽 A, B, C, D, E로 구분하였다. 벽체의 열관류율은 각각 0.171, 0.172, 0.221, 0.150, $0.079W/m^2K$이다. 벽 A와 C의 OSB 절대함수량은 기준치 20%를 초과하는 값이 나타났고, 결로 평가를 통하여 단열재 내부 표면에서 겨울철에 결로가 발생할 수 있음을 확인하였다. 벽 D와 E는 외단열 벽체로 다른 벽체에 비하여 함수량 평가와 결로 평가에서 우수한 결과를 보여주었다. 그러나 곰팡이 성장 위험 평가에서 5가지 형태의 벽체 모두 곰팡이 성장 위험성이 있음을 확인하였다. 이에 따라 외벽의 열 습기 성능의 차이는 열적 성능에 의한 발생보다는 레이어 구성에 따른 차이가 발생하는 것으로 판단되었다. 모든 벽체는 비슷한 열적 성능을 가지고 있으나 레이어에 따라 동일한 조건에서의 적합성이 다르게 나타나는 것을 확인하였다.