• Title/Summary/Keyword: Medical device industry

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Study on Developing Assessment Guideline for Safety and Performance of Electric Cupping Apparatus (전동식 부항기에 대한 안전성 및 성능평가 가이드라인 개발연구)

  • Yi, Seung-Ho;Kim, Eun-Jung;Shin, Kyung-Hoon;Nam, Dong-Woo;Kang, Jung-Won;Lee, Seung-Deok;Lee, Hye-Jung;Lee, Jae-Dong;Kim, Kap-Sung
    • Journal of Acupuncture Research
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    • v.26 no.6
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    • pp.101-110
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    • 2009
  • Objectives : We developed and proposed a guideline for safety and performance assessment of electric cupping apparatus(Class 2 medical device). Methods : We drafted the guideline for safety and performance assessment of electric cupping apparatus by referring the existing standards and guideline, based on online questionnaire for Korean medical doctors and measurement data from commercially available products. Physical dimension of cups and inner vacuum pressure were acquired for the measurement in order to achieve the purposes. Results : This guideline only can be applied to electric cupping apparatus for enhancing blood circulation by employing negative pressure generated by electricity. Seven items of appearance and label, operation test of pump, variation test of input electricity, vacuum level test, vacuum sustain test, cup-size dependent test, noise level test are suggested for evaluation subjects and methods required for electric cupping devices. Requirements for the design and development of electric cupping devices are suggested: vacuum level indicator, vacuum generation rate, pressure control, valve detachment stability, cup comparability, safety measure, surge protection, user friendliness, instruction for use (IFU). Conclusions : We proposed a guideline for safety and performance assessment of electric cupping apparatus to improve the quality of relating products and aid the commercialization of them, by aiming higher industrial competitiveness of the medical device sectors in Korea. Discussion with related institutes such as industry, academy and government is further required. Public hearings also need to be held prior to the establishment of a final guideline and standard.

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Study on Developing Assessment Guideline for Safety and Performance of Electric Moxibustion Apparatus (전기식 온구기에 대한 안전성 및 성능 평가 가이드라인 개발 연구)

  • Yi, Seung-Ho;Kang, Jung-Won;Nam, Dong-Woo;Kim, Eun-Jung;Lee, Hye-Jung;Kim, Kap-Sung;Lee, Jae-Dong
    • Journal of Acupuncture Research
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    • v.27 no.1
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    • pp.75-86
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    • 2010
  • Objectives : We developed and proposed a guideline for safety and performance assessment of electric moxibustion apparatus (class II medical device). Methods : We drafted the guideline for safety and performance assessment of electric moxibustion apparatus by referring the existing standards, guidelines and measurement data from commercially available products. Temperature characteristics such as maximum temperature and ramp time, and physical characteristics such as weight, noise and diameter were measured. User friendliness was also evaluated for commercial devices. Results : This guideline only can be applied to the electric moxibustion apparatus where moxa is being heated by electricity for medical proposes. Maximum temperature of higher than $50^{\circ}C$ can be achieved mostly. Ramp rate of temperature seems to be reliable. Control of temperature is needed to be improved. Moxa and its derivative products seem to be regulated for reliable temperature performance for clinical application. Requirements for design and development of electric moxibustion apparatus are suggested : temperature indicator, temperature control and its accuracy, safety measure, surge protection, user friendliness and instruction for use (IFU). Design recommendation of the reduction of noise level and energy loss are suggested for better products. Conclusions : We proposed a guideline for safety and performance assessment of electric moxibustion apparatus to improve the quality of relating products and aid their commercialization by aiming higher industrial competitiveness of the medical device sectors in Korea. Discussion with related institutes such as industry, academy and government is further required. Public hearings also need to be held prior to the establishment of a final guideline and standard.

2023 Survey on User Experience of Artificial Intelligence Software in Radiology by the Korean Society of Radiology

  • Eui Jin Hwang;Ji Eun Park;Kyoung Doo Song;Dong Hyun Yang;Kyung Won Kim;June-Goo Lee;Jung Hyun Yoon;Kyunghwa Han;Dong Hyun Kim;Hwiyoung Kim;Chang Min Park;Radiology Imaging Network of Korea for Clinical Research (RINK-CR)
    • Korean Journal of Radiology
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    • v.25 no.7
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    • pp.613-622
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    • 2024
  • Objective: In Korea, radiology has been positioned towards the early adoption of artificial intelligence-based software as medical devices (AI-SaMDs); however, little is known about the current usage, implementation, and future needs of AI-SaMDs. We surveyed the current trends and expectations for AI-SaMDs among members of the Korean Society of Radiology (KSR). Materials and Methods: An anonymous and voluntary online survey was open to all KSR members between April 17 and May 15, 2023. The survey was focused on the experiences of using AI-SaMDs, patterns of usage, levels of satisfaction, and expectations regarding the use of AI-SaMDs, including the roles of the industry, government, and KSR regarding the clinical use of AI-SaMDs. Results: Among the 370 respondents (response rate: 7.7% [370/4792]; 340 board-certified radiologists; 210 from academic institutions), 60.3% (223/370) had experience using AI-SaMDs. The two most common use-case of AI-SaMDs among the respondents were lesion detection (82.1%, 183/223), lesion diagnosis/classification (55.2%, 123/223), with the target imaging modalities being plain radiography (62.3%, 139/223), CT (42.6%, 95/223), mammography (29.1%, 65/223), and MRI (28.7%, 64/223). Most users were satisfied with AI-SaMDs (67.6% [115/170, for improvement of patient management] to 85.1% [189/222, for performance]). Regarding the expansion of clinical applications, most respondents expressed a preference for AI-SaMDs to assist in detection/diagnosis (77.0%, 285/370) and to perform automated measurement/quantification (63.5%, 235/370). Most respondents indicated that future development of AI-SaMDs should focus on improving practice efficiency (81.9%, 303/370) and quality (71.4%, 264/370). Overall, 91.9% of the respondents (340/370) agreed that there is a need for education or guidelines driven by the KSR regarding the use of AI-SaMDs. Conclusion: The penetration rate of AI-SaMDs in clinical practice and the corresponding satisfaction levels were high among members of the KSR. Most AI-SaMDs have been used for lesion detection, diagnosis, and classification. Most respondents requested KSR-driven education or guidelines on the use of AI-SaMDs.

Inter-device Mutual authentication and Formal Verification in M2M Environment (M2M 환경에서 장치간 상호 인증 및 정형검증)

  • Bae, WooSik
    • Journal of Digital Convergence
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    • v.12 no.9
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    • pp.219-223
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    • 2014
  • In line with the advanced wireless communication technology, M2M (Machine-to-Machine) communication has drawn attention in industry. M2M communication features are installed and operated in the fields where human accessibility is highly limited such as disaster, safety, construction, health and welfare, climate, environment, logistics, culture, defense, medical care, agriculture and stockbreeding. In M2M communication, machine replaces people for automatic communication and countermeasures as part of unmanned information management and machine operation. Wireless M2M inter-device communication is likely to be exposed to intruders' attacks, causing security issues, which warrants proper security measures including cross-authentication of whether devices are legitimate. Therefore, research on multiple security protocols has been conducted. The present study applied SessionKey, HashFunction and Nonce to address security issues in M2M communication and proposed a safe protocol with reinforced security properties. Notably, unlike most previous studies arguing for the security of certain protocols based on mathematical theorem proving, the present study used the formal verification with Casper/FDR to prove the safety of the proposed protocol. In short, the proposed protocol was found to be safe and secure.

Design of BLDC Motor Control Circuit for Electric Driver using UC3625 Controller IC (UC3625 Controller IC를 이용한 전동 Driver용 BLDC 전동기 제어회로 설계)

  • Jeong, Sungin
    • The Journal of the Institute of Internet, Broadcasting and Communication
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    • v.21 no.4
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    • pp.129-134
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    • 2021
  • A power tool is a tool used to manufacture and process various structures using a motor that is a power source. Using a motor that uses electricity as a power source, a reduction device, power transmission and conversion device functions are built-in to make the tool rotate, reciprocate, and vibrate. It is a work tool designed to assist the user's movement skills. In the case of Korea, the power tool industry has a short history and is lagging behind advanced countries such as Germany, the United States, and Japan in terms of technology level, market share, and recognition. In addition, electric drivers used in Korea are foreign products from the US and European countries, and the domestic market also prefers 100% foreign companies, and multinational companies are investing a lot in the domestic market. Therefore, technological development must follow in order to develop domestic technology and secure a consistently high market share. The purpose of this thesis is to design a motor driver with high output performance of motor performance, miniaturization, and high speed in accordance with the basic performance requirements of power tools, and finally research developments that can be applied to industrial and medical applications.

Deep Learning-Based Companion Animal Abnormal Behavior Detection Service Using Image and Sensor Data

  • Lee, JI-Hoon;Shin, Min-Chan;Park, Jun-Hee;Moon, Nam-Mee
    • Journal of the Korea Society of Computer and Information
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    • v.27 no.10
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    • pp.1-9
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    • 2022
  • In this paper, we propose the Deep Learning-Based Companion Animal Abnormal Behavior Detection Service, which using video and sensor data. Due to the recent increase in households with companion animals, the pet tech industry with artificial intelligence is growing in the existing food and medical-oriented companion animal market. In this study, companion animal behavior was classified and abnormal behavior was detected based on a deep learning model using various data for health management of companion animals through artificial intelligence. Video data and sensor data of companion animals are collected using CCTV and the manufactured pet wearable device, and used as input data for the model. Image data was processed by combining the YOLO(You Only Look Once) model and DeepLabCut for extracting joint coordinates to detect companion animal objects for behavior classification. Also, in order to process sensor data, GAT(Graph Attention Network), which can identify the correlation and characteristics of each sensor, was used.

An Embedded FPGA Implementation for a Cameralink Interface (카메라링크 접속을 위한 임베디드 FPGA의 구현)

  • Lee, Chang-Su
    • Journal of IKEEE
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    • v.15 no.2
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    • pp.122-128
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    • 2011
  • Although conventional analog linescan cameras are used widely, high-speed, high-resolution Cameralink standard will lead the area of frame grabber industry such as factory automation. In this paper, we are developing embedded frame grabber testbed without PC which will give an another solution to image processing applications. Therefore, we designed hardware schematics and programmed FPGA device with VHDL in order to interface Cameralink standard linescan CCD camera. In the future, our embedded on-chip controller could be applied to various image processing systems such as medical imaging, especially optical coherence tomography, machine vision and industrial electronics.

A Study on the Emoticon Extraction based on Facial Expression Recognition using Deep Learning Technique (딥 러닝 기술 이용한 얼굴 표정 인식에 따른 이모티콘 추출 연구)

  • Jeong, Bong-Jae;Zhang, Fan
    • Korean Journal of Artificial Intelligence
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    • v.5 no.2
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    • pp.43-53
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    • 2017
  • In this paper, the pattern of extracting the same expression is proposed by using the Android intelligent device to identify the facial expression. The understanding and expression of expression are very important to human computer interaction, and the technology to identify human expressions is very popular. Instead of searching for the emoticons that users often use, you can identify facial expressions with acamera, which is a useful technique that can be used now. This thesis puts forward the technology of the third data is available on the website of the set, use the content to improve the infrastructure of the facial expression recognition accuracy, in order to improve the synthesis of neural network algorithm, making the facial expression recognition model, the user's facial expressions and similar e xpressions, reached 66%.It doesn't need to search for emoticons. If you use the camera to recognize the expression, itwill appear emoticons immediately. So this service is the emoticons used when people send messages to others, and it can feel a lot of convenience. In countless emoticons, there is no need to find emoticons, which is an increasing trend in deep learning. So we need to use more suitable algorithm for expression recognition, and then improve accuracy.

A Design of Air Compressor Remote Control System Using USN Technology (USN 기술을 이용한 공기압축기 원격관리 시스템 설계)

  • Hwang, Moon-Young
    • Korean Journal of Artificial Intelligence
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    • v.6 no.1
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    • pp.1-10
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    • 2018
  • Compressed Air is an important energy source used in most factories nowadays. The automation trend using air compressor has been gradually increasing with the interest of the 4th industry in recent years. With the air compressor system, it is possible to construct the device at low cost and easily achieve automation and energy saving. In addition, With trend of FA, miniaturation and light weight manufacturing trend expand their use in the electronics, medical, and food sectors. Research method is to design the technology for the remote control of the following information as USN base. Development of flexible sensing module from real time observation module for fusion of IT technology in compressed air systems, design and manufacture of flexible sensing module, and realiability assessment. Design of real-time integrated management system for observation data of compressed air system - Ability to process observation data measured in real time into pre-processing and analysis data. This study expects unconventionally decreasing effect of energy cost that takes up 60~70% of air compressor layout and operation and maintenance management cost through USN(Ubiquitous Sensor Network) technology by using optimum operational condition from real time observation module. In addition, by preventing maintenance cost from malfunction of air compressor beforehand, maintenance cost is anticipated to cut back.

Study on the Development of Photoelastic Experiment of Orthotropic Material (I) (직교 이방성의 광탄성 실험법 개발에 관한 연구 I)

  • 최선호;황재석
    • Transactions of the Korean Society of Mechanical Engineers
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    • v.12 no.1
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    • pp.8-18
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    • 1988
  • In the composite structures or the concrete structures, to analyze stress concentration factor, stress distributions and fracture mechanics of them under forces by photoelastic experiment, it is natural that to develope photoelastic model material for them is surely necessary. Thus, the orthotropic photoelastic model material for the transparent type photoelastic device was developed in the paper, it is called Copper Fiber Epoxy Composite and abbreviated as E.F.E.C. It was found that C.F.E.C. developed in this paper was satisfied with the properties of photoelastic model material that the photoelastic model material should have and that C.F.E.C. had completely properties of composite material. It is thought that C.F.E.C. can be applied to both medical engineering for modeling biological tissue and to the aerospace industry as orthotropic photoelastic material.