• Title/Summary/Keyword: External Validation

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Principles for evaluating the clinical implementation of novel digital healthcare devices (첨단 디지털 헬스케어 의료기기를 진료에 도입할 때 평가원칙)

  • Park, Seong Ho;Do, Kyung-Hyun;Choi, Joon-Il;Sim, Jung Suk;Yang, Dal Mo;Eo, Hong;Woo, Hyunsik;Lee, Jeong Min;Jung, Seung Eun;Oh, Joo Hyeong
    • Journal of the Korean Medical Association
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    • v.61 no.12
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    • pp.765-775
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    • 2018
  • With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, 'digital exceptionalism' (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.

Development and Validation of the Coupled System of Unified Model (UM) and PArameterized FOG (PAFOG) (기상청 현업 모형(UM)과 1차원 난류모형(PAFOG)의 접합시스템 개발 및 검증)

  • Kim, Wonheung;Yum, Seong Soo
    • Atmosphere
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    • v.25 no.1
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    • pp.149-154
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    • 2015
  • As an attempt to improve fog predictability at Incheon International Airport (IIA) we couple the 3D weather forecasting model currently operational in Korea Meteorological Administration (regional Unified Model, UM_RE) with a 1D turbulence model (PAFOG). The coupling is done by extracting the meteorological data from the 3D model and properly inserting them in the PAFOG model as initial conditions and external forcing. The initial conditions include surface temperature, 2 m temperature and dew point temperature, geostrophic wind at 850 hPa and vertical profiles of temperature and dew point temperature. Moisture and temperature advections are included as external forcing and updated every hr. To validate the performance of the coupled system, simulation results of the coupled system are compared to those of the 3D model alone for the 22 sea fog cases observed over the Yellow Sea. Three statistical indices, i.e., Root Mean Square Error (RMSE), linear correlation coefficient (R) and Critical Success Index (CSI), are examined, and they all indicate that the coupled system performs better than the 3D model alone. These are certainly promising results but more improvement is required before the coupled system can actually be used as an operational fog forecasting model. For the RMSE, R, and CSI values for the coupled system are still not good enough for operational fog forecast.

Finite Element Analysis on Buckling Pressure of Composite Pressure Hull (복합재 내압선체의 좌굴압력에 관한 유한요소해석)

  • Cho, J.R.;Jung, H.Y.;Kwon, J.H.;Choi, J.H.;Cho, Y.S.
    • Proceedings of the Korean Society of Marine Engineers Conference
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    • 2005.11a
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    • pp.212-213
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    • 2005
  • The results of an experimental and analytical study of composite pressure hull on buckling pressure are presented for URN 300. We predicted the buckling and post buckling analysis of composite laminated cylindrical shell and panel under external compression by using ABAQUS/Standard[Ver 6.4]. To obtain nonlinear static equilibrium solutions for unstable problems, where the load-displacement response can exhibit the type of nonlinear buckling behavior, during periods of the response, the load and/or the displacement may decrease as the solution evolves, used the modified Riks method. Experiments were conducted to verify the validation of present analysis for cross-ply laminated shells. The shells considered in the study have four different lamination patterns, [${\pm}{\Theta}$/0/90]$_{14s}$,[${\pm}{\Theta}_{14}$/$0_{14}$/$90_{14}$],[${\pm}$45/0/90]$_{18s}$ and [/0/90]$_{18s}$. At the result of this study, the optimized ply orientation angle is $75^{\circ}$. The critical load from experiment is 69% of that of numerical analysis, because the fracture of matrix was generated before buckling. So URN 300 is not proper to use at the condition under high external pressure.

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Validity and Reliability of an Inertial Measurement Unit-Based 3D Angular Measurement of Shoulder Joint Motion

  • Yoon, Tae-Lim
    • The Journal of Korean Physical Therapy
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    • v.29 no.3
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    • pp.145-151
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    • 2017
  • Purpose: The purpose of this study was to investigate the validity and reliability of the measurement of shoulder joint motions using an inertial measurement unit (IMU). Methods: For this study, 33 participants (32 females and 1 male) were recruited. The subjects were passively positioned with the shoulder placed at specific angles using a goniometer (shoulder flexion $0^{\circ}-170^{\circ}$, abduction $0^{\circ}-170^{\circ}$, external rotation $0^{\circ}-90^{\circ}$, and internal rotation $0^{\circ}-60^{\circ}$ angles). Kinematic data on the shoulder joints were simultaneously obtained using IMU three-dimensional (3D) angular measurement (MyoMotion) and photographic measurement. Test-retest reliability and concurrent validity were examined. Results: The MyoMotion system provided good to very good relative reliability with small standard error of measurement (SEM) and minimal detectable change (MDC) values from all three planes. It also presented acceptable validity, except for some of shoulder flexion, shoulder external rotation, and shoulder abduction. There was a trend for the shoulder joint measurements to be underestimated using the IMU 3D angular measurement system compared to the goniometer and photo methods in all planes. Conclusion: The IMU 3D angular measurement provided a reliable measurement and presented acceptable validity. However, it showed relatively low accuracy in some shoulder positions. Therefore, using the MyoMotion measurement system to assess shoulder joint angles would be recommended only with careful consideration and supervision in all situations.

Numerical Simulation on the ULPU-V Experiments using RPI Model (RPI모형을 이용한 ULPU-V시험의 수치모사)

  • Suh, Jungsoo;Ha, Huiun
    • Journal of the Korean Society of Safety
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    • v.32 no.2
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    • pp.147-152
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    • 2017
  • The external reactor vessel cooling (ERVC) is well known strategy to mitigate a severe accident at which nuclear fuel inside the reactor vessel is molten. In order to compare the heat removal capacity of ERVC between the nuclear reactor designs quantitatively, numerical method is often used. However, the study for ERVC using computational fluid dynamics (CFD) is still quite scarce. As a validation study on the numerical prediction for ERVC using CFD, the subcooled boiling flow and natural circulation of coolant at the ULPU-V experiment was simulated. The commercially available CFD software ANSYS-CFX was used. Shear stress transport (SST) model and RPI model were used for turbulence closure and wall-boiling, respectively. The averaged flow velocities in the downcomer and the baffle entry under the reactor vessel lower plenum are in good agreement with the available experimental data and recent computational results. Steam generated from the heated wall condenses rapidly and coolant flows maintains single-phase flow until coolant boils again by flashing process due to the decrease of saturation temperature induced by higher elevation. Hence, the flow rate of coolant natural circulation does not vary significantly with the change of heat flux applied at the reactor vessel, which is also consistent with the previous literatures.

Stiffness Analysis of External Fixation System with System Configuration Parameters (시스템 구성 인자를 고려한 외고정장치 시스템의 강성 해석)

  • Kim Yoon Hyuk;Lee Hyun Keun
    • Journal of Biomedical Engineering Research
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    • v.25 no.6
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    • pp.531-536
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    • 2004
  • In fracture treatment with external fixators, the inter-fragmentary movements at the fracture site affect the fracture healing process, and these movements are highly related to the stiffness of external fixation systems. Therefore, in order to provide the optimal fracture healing at the fracture site, it is essential to understand the relationship between the stiffness and the system configurations in external fixation system. In this study we investigated the influences of system configuration parameters on the stiffness in the finite element analysis of an external fixation system of a long bone. The system alignment, the geometric and the material non-linearity of the pin, the joint stiffness and the callus formation were considered in the finite element model. In the first, the system stiffness of the developed finite element model was compared with the experiment data for model validation. The consideration of the joint stiffness and nonlinearity of the model improved the system stiffness results. The joint stiffness, the non-alignment of the system decreased the system stiffness while the callus formation increased the system stiffness. The present results provided the biomechanical basis of rational guidelines for design improvements of external fixators and pre-op. planning to maximize the system stiffness in fracture surgery.

Aeroelastic-aerodynamic analysis and bio-inspired flow sensor design for boundary layer velocity profiles of wind turbine blades with active external flaps

  • Sun, Xiao;Tao, Junliang;Li, Jiale;Dai, Qingli;Yu, Xiong
    • Smart Structures and Systems
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    • v.20 no.3
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    • pp.311-328
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    • 2017
  • The characteristics of boundary layers have significant effects on the aerodynamic forces and vibration of the wind turbine blade. The incorporation of active trailing edge flaps (ATEF) into wind turbine blades has been proven as an effective control approach for alleviation of load and vibration. This paper is aimed at investigating the effects of external trailing edge flaps on the flow pattern and velocity distribution within a boundary layer of a NREL 5MW reference wind turbine, as well as designing a new type of velocity sensors for future validation measurements. An aeroelastic-aerodynamic simulation with FAST-AeroDyn code was conducted on the entire wind turbine structure and the modifications were made on turbine blade sections with ATEF. The results of aeroelastic-aerodynamic simulations were combined with the results of two-dimensional computational fluid dynamic simulations. From these, the velocity profile of the boundary layer as well as the thickness variation with time under the influence of a simplified load case was calculated for four different blade-flap combinations (without flap, with $-5^{\circ}$, $0^{\circ}$, and $+5^{\circ}$ flap). In conjunction with the computational modeling of the characteristics of boundary layers, a bio-inspired hair flow sensor was designed for sensing the boundary flow field surrounding the turbine blades, which ultimately aims to provide real time data to design the control scheme of the flap structure. The sensor element design and performance were analyzed using both theoretical model and finite element method. A prototype sensor element with desired bio-mimicry responses was fabricated and validated, which will be further refined for integration with the turbine blade structures.

A UAV Flight Control Algorithm for Improving Flight Safety (무인항공기 비행제어컴퓨터 알고리즘 개발을 통한 비행안전성 향상)

  • Park, Suncheol;Jung, Sungrok;Chung, Myungjin
    • Journal of KIISE
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    • v.44 no.6
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    • pp.559-565
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    • 2017
  • A UAV(unmanned aerial vehicle) requires higher reliability for external effects such as electromagnetic interference because a UAV is operated by pre-designed programs that are not under human control. The design of a small UAV with a complete resistance against the external effects, however, is difficult because of its weight and size limitation. In this circumstance, a conventional small UAV dropped to the ground when an external effect caused the rebooting of the flight-control computer(FCC); therefore, this paper presents a novel algorithm for the improvement of the flight safety of a small UAV. The proposed algorithm consists of three steps. The first step comprises the calibration of the navigation equipment and validation of the calibrated data. The second step is the storage of the calibration data from the UAV take-off. The third step is the restoration of the calibration data when the UAV is in flight and FCC has been rebooted. The experiment results show that the flight-control system can be safely operated upon the rebooting of the FCC.

Detection of Pulmonary Region in Medical Images through Improved Active Control Model

  • Kwon Yong-Jun;Won Chul-Ho;Kim Dong-Hun;Kim Pil-Un;Park Il-Yong;Park Hee-Jun;Lee Jyung-Hyun;Kim Myoung-Nam;Cho Jin-HO
    • Journal of Biomedical Engineering Research
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    • v.26 no.6
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    • pp.357-363
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    • 2005
  • Active contour models have been extensively used to segment, match, and track objects of interest in computer vision and image processing applications, particularly to locate object boundaries. With conventional methods an object boundary can be extracted by controlling the internal energy and external energy based on energy minimization. However, this still leaves a number of problems, such as initialization and poor convergence in concave regions. In particular, a contour is unable to enter a concave region based on the stretching and bending characteristic of the internal energy. Therefore, this study proposes a method that controls the internal energy by moving the local perpendicular bisector point of each control point on the contour, and determines the object boundary by minimizing the energy relative to the external energy. Convergence at a concave region can then be effectively implemented as regards the feature of interest using the internal energy, plus several objects can be detected using a multi-detection method based on the initial contour. The proposed method is compared with other conventional methods through objective validation and subjective consideration. As a result, it is anticipated that the proposed method can be efficiently applied to the detection of the pulmonary parenchyma region in medical images.

Prediction of Intravenous Immunoglobulin Nonresponse Kawasaki Disease in Korea (한국인에서 면역글로불린-저항성 가와사키병 환자의 예측)

  • Choi, Myung Hyun;Park, Chung Soo;Kim, Dong Soo;Kim, Ki Hwan
    • Pediatric Infection and Vaccine
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    • v.21 no.1
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    • pp.29-36
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    • 2014
  • Purpose: The objective of this study was to find the predictors and generate a prediction scoring model of nonresponse to intravenous immunoglobulin in patients with Kawasaki disease. Methods: We examined 573 children diagnosed with KD at the Severance Children's Hospital between January 2009 and december 2012. We retrospectively reviewed their medical records. These patients were divided into 2 groups; the experimental group (N=433) and the validation group (N=140). Each group were divided into 2 groups the intravenous immunoglobulin nonresponders and the responders. Multivariate logistic regression analysis identified predictive factors of intravenous immunoglobulin nonresponders which make predictive scoring model. We practice internal validation and external validation. Results: Multivariate logistic regression analysis identified male, cervical lymphadenopathy, changes of the extremities, platelet, total bilirubin, alkaline phophatase, lactate dehydrogenase, C-reactive protein as significant predictors for nonresponse to intravenous immunoglobulin. We generated prediction score assigning 1 point for (1) male, (2) cervical lymphadenopathy, (3) changes of the extremities, (4) platelet (${\leq}368,000/mm^3$), (5) total bilirubin (${\geq}0.4mg/dL$), (6) alkaline phophatase (${\geq}227IU/L$), (7) lactate dehydrogenase (${\geq}268IU/L$), (8) C-reactive protein (>77.1 mg/dL). Using a cut-off point of 4 and more with this prediction score, we could identify the intravenous immunoglobulin nonresponder group. Sensitivity and specificity were 52.5% and 82.4% in experimental group and 37.8% and 81.8% in validation group, respectively. Conclusion: Our predictive scoring models had high specificity and low sensitivity in Korean patients. Therefore it is useful in predicting nonresponse to intravenous immunoglobulin with Kawasaki disease.