• Journal of the Korea Safety Management & Science
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• v.17 no.4
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• pp.223-229
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• 2015

In this study, We designed and implemented a assistant device for the standing X-ray views which is the one of the clinical X-ray imaging position. To evaluate the usability of the proposed assistant device, We choose 11 clinical patient postures that are used frequently and applied the postures to 5 volunteers. 11 images was taken from a volunteer for the patient postures. And we conducted a survey on safety and clinical usefulness, the 5 volunteers responded to the safety and 5 experts responded to the clinical usefulness. The survey results show that the volunteers feel more safe and the obtained images are very clear and clinically useful. The result for the image quality is 4.69 of 5(best) and safety is 2.84 of 3(best). It will be very profitable to both patients and hospitals by using the proposed assistant device.

• Korean Journal of Radiology
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• v.22 no.3
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• pp.442-453
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• 2021

Artificial intelligence (AI) will likely affect various fields of medicine. This article aims to explain the fundamental principles of clinical validation, device approval, and insurance coverage decisions of AI algorithms for medical diagnosis and prediction. Discrimination accuracy of AI algorithms is often evaluated with the Dice similarity coefficient, sensitivity, specificity, and traditional or free-response receiver operating characteristic curves. Calibration accuracy should also be assessed, especially for algorithms that provide probabilities to users. As current AI algorithms have limited generalizability to real-world practice, clinical validation of AI should put it to proper external testing and assisting roles. External testing could adopt diagnostic case-control or diagnostic cohort designs. A diagnostic case-control study evaluates the technical validity/accuracy of AI while the latter tests the clinical validity/accuracy of AI in samples representing target patients in real-world clinical scenarios. Ultimate clinical validation of AI requires evaluations of its impact on patient outcomes, referred to as clinical utility, and for which randomized clinical trials are ideal. Device approval of AI is typically granted with proof of technical validity/accuracy and thus does not intend to directly indicate if AI is beneficial for patient care or if it improves patient outcomes. Neither can it categorically address the issue of limited generalizability of AI. After achieving device approval, it is up to medical professionals to determine if the approved AI algorithms are beneficial for real-world patient care. Insurance coverage decisions generally require a demonstration of clinical utility that the use of AI has improved patient outcomes.

• Journal of Veterinary Clinics
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• v.37 no.6
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• pp.331-335
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• 2020

A 13-year-old female Poodle presented with gallbladder rupture caused by a mucocele and hypoperfusion. The animal had a thermal burn injury caused by a forced-air warming device used for hypothermia during surgery. This could be attributed to two causes. First, the forced-air warming device was used with direct hosing, without attachment to an air blanket, and the heat was concentrated in a single area. Second, perioperative peripheral hypoperfusion hampered heat dissipation and increased the susceptibility to a burn injury. These findings suggest that an air blanket should be used with a forced-air warming device according to the manufacturer's instructions. Furthermore, patients with peripheral hypoperfusion are at a higher risk of burn injuries and require close monitoring.

• Journal of Dental Anesthesia and Pain Medicine
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• v.18 no.4
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• pp.197-204
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• 2018

Pain control by means of local anesthesia is an intrinsic part of clinical practice in dentistry. Several studies evaluated intraligamental anesthesia using a computer-controlled anesthetic device in children. There is a need to provide a clinical guide for the use of computerized intraligamental anesthesia in children. Intraligamental anesthesia using a computer-controlled anesthetic device was found to cause significantly lower pain perception scores and lower pain-related behavior than traditional techniques. This device proven to be effective in restorative and pulp treatment in children; however, its effectiveness in primary teeth extraction is controversial. It is important to withdraw recommendations necessity of future studies concerning the side effects of computerized intraligamental anesthesia in children. The present study aims to review different clinical aspects of computerized intraligamental anesthesia in children along with the side-effects, type of local anesthesia and postoperative pain of this technique. This study provides dentists with a clinical guide for the use of computerized intraligamental anesthesia.

• The Journal of Internal Korean Medicine
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• v.39 no.4
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• pp.612-623
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• 2018

Objective: The aim of this research was to investigate the current status and limitations of the clinical use of a pulse tonometry device (PTD). Methods: We searched online medical databases, including Oriental Medicine Advanced Searching Integrated System (OASIS), Research Information Sharing Service (RISS), DataBase Periodical Information Academic (DBpia) and PubMed, for clinical studies of metabolic diseases that used PTD. We selected articles on the clinical application of the PTD but excluded duplicate articles, clinical studies without the PTD, and non-clinical studies. In the first screening, 551 articles were selected. Ultimately, we found 10 articles and classified the articles according to the following diseases: hyperlipidemia, diabetes, overweight and obesity, hypertension, and metabolic disease. Results: Of the 10 selected articles, 4 were focused on hypertension. Two articles were focused on overweight or obesity and two articles were focused on the metabolic disease. Conclusions: This study was the first attempt to conduct a systematic review on clinical studies of metabolic disease using the PTD as a primary outcome. We suggest that the standard of pulse wave parameters and operating procedures for the PTD should be further developed. The results of this study are expected to be used as basic information for the planning and progression of clinical studies of metabolic syndrome using PTD.

• Nuclear Medicine and Molecular Imaging
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• v.41 no.1
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• pp.68-69
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• 2007

A 44-year-old female underwent three-phase bone scintigraphy for an evaluation of right hip joint pain. The blood-flow and blood-pool images show a pelvic blush with a photopenic center (doughnut) prior to bladder filling. On the three hour delayed image, the pelvic uptake disappeared. The scintigraphic findings indicated the possibility of an early pregnancy. However, plain radiography demonstrated an intrauterine device. A uterine doughnut developed as a result of photon attenuation of intrauterine device.

• Korean Journal of Digital Imaging in Medicine
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• v.10 no.2
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• pp.33-37
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• 2008

To keep the online medical records available to anyone without constraint of time and space, introducing EMR (Electronic medical record), which is a clinical support management system. The purpose of this study is to develop interface standard of clinical test device. Integration and sharing of medical information is faced with enormous obstacles because medical organizations and associated companies are separately developing the interface. I hope that multi-function management system with workstation concept is operated to efficiently transmit clinical device result data based on this study. Transfer of precise medical result data available for decision making will improve quality of health care service.

• Journal of Biomedical Engineering Research
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• v.40 no.6
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• pp.250-259
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• 2019

Ophthalmic Laser System is widely used in Selective Laser Trabeculoplasty of Open Angle Glaucoma and Ocular Hypertension. Versatile ophthalmic laser system is a medical device with technology that checks the condition of the treatment area by irradiating a continuous laser pulse on the treatment area, and monitoring the microbubble reaction caused by the temperature increase of the melanosome through the ultrasonic signal and the optical signal sensor. It performs selective laser treatment without damaging the photoreceptor by controlling the wavelength of the laser when microbubbles are detected. This study aims to suggest a guideline for evaluating safety, performance and clinical effectiveness of Versatile Ophthalmic Laser System in accordance with the growing technology. International Standards, Regulations, and Clinical Trial Protocols were investigated and analyzed for this study. As a result of this study, the safety, performance and clinical effectiveness test guideline for Versatile Ophthalmic Laser System were proposed. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of technology development by supporting a clinical trial plan.

• Korea Journal of Hospital Management
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• v.23 no.4
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• pp.15-25
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• 2018

Purposes: The objectives of this study present the direction of the criteria for the separately reimbursement of therapeutic medical device. Methodology: We summarized experts' opinion using Delphi survey and Analytic Hierarchy Process(AHP). 48 experts were gathered from Medical Insurance Review Nurses Association, medical device industry, academy and association, Medical Device Expert Evaluation Committee. Descriptive statistics, consistency index, content validity ratio were analyzed. Findings: Clinical utility, patient safety, infection control, cost-homogeneity, cost-effectiveness showed high feasibility and importance, but market contribution and functional utility showed low feasibility and importance in a relative sense. The results of functional utility differed between clinical and non-clinical experts. Measurability was low across the whole area. Among the criteria for the separately reimbursement of therapeutic medical device. Patient safety/infection control and clinical utility showed the highest relative importance values, analyzed using AHP. Practical Implications: Patient safety and infection control are needed to be considered as one of Value Assessment Criteria. It is important to find out how to improve the measurability of therapeutic medical device.

• Journal of Korean Neurosurgical Society
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• v.58 no.4
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• pp.316-320
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• 2015

Objective : The main concern during transfemoral carotid artery stenting (CAS) is preventing cerebral embolus dislodgement. We compared clinical outcomes and intraprocedural embolization rates of CAS using a distal filter protection device or proximal balloon occlusion device. Methods : From January 2011 to March 2015, a series of 58 patients with symptomatic or asymptomatic internal carotid artery stenosis ${\geq}70%$ were treated with CAS with embolic protection device in single center. All patients underwent post-CAS diffusion-weighted magnetic resonance imaging (DW-MRI) to detect new ischemic lesions. We compared clinical outcomes and postprocedural embolization rates. Results : CAS was performed in all 61 patients. Distal filter protection success rate was 96.6% (28/29), whose mean age was 70.9 years, and mean stenosis was 81%. Their preprocedural infarction rate was 39% (11/28). Subsequent DW-MRI revealed 96 new ischemic lesions in 71% (20/28) patients. In contrast, the proximal balloon occlusion device success rate was 93.8% (30/32), whose mean age was 68.8 years and mean stenosis was 86%. Preprocedure infarction rate was 47% (14/30). DW-MRI revealed 45 new ischemic lesions in 57% (17/30) patients. Compared with distal filter protection device, proximal balloon occlusion device resulted in fewer ischemic lesions per patient (p=0.028). In each group, type of stent during CAS had no significant effect on number of periprocedural embolisms. Only 2 neurologic events occurred in the successfully treated patients (one from each group). Conclusion : Transfemoral CAS with proximal balloon occlusion device achieves good results. Compared with distal filter protection, proximal balloon occlusion might be more effective in reducing cerebral embolism during CAS.