In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.
Journal of the Korea Academia-Industrial cooperation Society
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v.11
no.3
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pp.847-852
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2010
Text in natural images has a various and important feature of image. Therefore, to detect text and extraction of text, recognizing it is a studied as an important research area. Lately, many applications of various fields is being developed based on mobile phone camera technology. Detecting edge component form gray-scale image and detect an boundary of text regions by local standard deviation and get an connected components using Euclidean distance of RGB color space. Labeling the detected edges and connected component and get bounding boxes each regions. Candidate of text achieved with heuristic rule of text. Detected candidate text regions was merged for generation for one candidate text region, then text region detected with verifying candidate text region using ectilarity characterization of adjacency and ectilarity between candidate text regions. Experctental results, We improved text region detection rate using completentary of edge and color connected component.
Park, Seongmo;Choi, Byoung Gun;Kang, Taewook;Park, Kyunghwan;Kwon, Youngsu;Kim, Jongbum
ETRI Journal
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v.42
no.4
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pp.518-526
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2020
This paper presents an efficient hardware random-number generator based on a beta source. The proposed generator counts the values of "0" and "1" and provides a method to distinguish between pseudo-random and true random numbers by comparing them using simple cumulative operations. The random-number generator produces labeled data indicating whether the count value is a pseudo- or true random number according to its bit value based on the generated labeling data. The proposed method is verified using a system based on Verilog RTL coding and LabVIEW for hardware implementation. The generated random numbers were tested according to the NIST SP 800-22 and SP 800-90B standards, and they satisfied the test items specified in the standard. Furthermore, the hardware is efficient and can be used for security, artificial intelligence, and Internet of Things applications in real time.
Proceedings of the Korean Society of Postharvest Science and Technology of Agricultural Products Conference
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2003.10a
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pp.26-32
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2003
Rice is one of the most important cereals in the world. Japanese people use about 9 million tons of rice per you. We use rice for cooked rice as staple foods and for processing, such as rice wine (sake), rice crackers and miso fermentation, etc. Palatability, eating quality, of rice is evaluated by the sensory test and various kinds of physicochemical measurements. Japanese National Food Agency started the storage of 1.5 million tones of rice in 1996. We carried out the storage test using high quality rices since 1995 until 1996. As indices for the quality deteriorations of rice grains during the storage, germination ratio, enzyme activities, fat acidity, physical properties of cooked rice were clarified to be useful. We applied colorimetric method for the measurements of fat acidities in the place of titration method. Processing suitabilities of rice differ depending on the products. Low amylose rice is more suitable for soft rice crackers and high amylose rice is preferred more for rice noodle. Pre-cooked rice products, such as frozen cooked rice, retort-pouched rice and aseptic rice, are increasing recently in Japan. In addition to above-mentioned physico-chemical tests, NIR spectroscopy,“Midometer”and“Taste sensor”are novel and useful to evaluate eating quality and processing suitabolities. Recently, rice wholesalers and retailers have been obligated to display the name of cultivar, location of cultivation and the year of production of rice grains which they sell by the Japanese Agricultural Standard Law (JAS). In order to detect the dishonest labeling of rice cultivars, we developed new cultivar identification method based on DNA polymorphism.
Objective : In order to establish the index of degeneration, the authors performed a histochemical study with Safranin-O staining and investigated the occurrence of apoptosis in the human intervertebral disc. Methods : Eighteen intervertebral disc specimens surgically extracted from the patients and two additional specimens from the autopsied cases were stained with Safranin-O for proteoglycan according to a standard protocol. Terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate- biotin nick end labeling[TUNEL] was used to detect the fragmented DNA known to be associated with apoptotic cell death and classification scheme was formulated for categorization of the degree of Safranin-O staining [normal, moderate reduction, faint] by modification of Makin's histological-histochemical grading. The Kruskal-Wallis H test and Chi-square test were used for statistical analysis. Results : The statistical results showed a significant difference in the mean age between "normal" Safranin-O staining group and the others [19.3 versus 55, 43.4, p=0021]. However, there was no statistically significant correlation between Safranin-O staining and MR grading of disc degeneration. Only six of eighteen surgical specimens and none in autopsies showed positive apoptotic cells in TUNEL staining. Conclusion : The determination of the degree of degeneration in surgically obtained disc tissue per se by histochemical staining or by the degree of apoptosis that corresponds to its morphologic change was not feasible.
In this paper, the purpose is to create a standard of AI training dataset type for commercial space design. As the market size of the field of space design continues to increase and the time spent increases indoors after COVID-19, interest in space is expanding throughout society. In addition, more and more consumers are getting used to the digital environment. Therefore, If you identify trends and preemptively propose the atmosphere and specifications that customers require quickly and easily, you can increase customer trust and conduct effective sales. As for the data set type, commercial districts were divided into a total of 8 categories, and images that could be processed were derived by refining 4,009,30MB JPG format images collected through web crawling. Then, by performing bounding and labeling operations, we developed a 'Dataset for AI Training' of 3,356 commercial space image data in CSV format with a size of 2.08MB. Through this study, elements of spatial images such as place type, space classification, and furniture can be extracted and used when developing AI algorithms, and it is expected that images requested by clients can be easily and quickly collected through spatial image input information.
Omission of noun phrases for obligatory cases is a common phenomenon in sentences of Korean and Japanese, which is not observed in English. When an argument of a predicate can be filled with a noun phrase co-referential with the title, the argument is more easily omitted in Encyclopedia texts. The omitted noun phrase is called a zero anaphor or zero pronoun. Encyclopedias like Wikipedia are major source for information extraction by intelligent application systems such as information retrieval and question answering systems. However, omission of noun phrases makes the quality of information extraction poor. This paper deals with the problem of developing a system that can restore omitted noun phrases in encyclopedia documents. The problem that our system deals with is almost similar to zero anaphora resolution which is one of the important problems in natural language processing. A noun phrase existing in the text that can be used for restoration is called an antecedent. An antecedent must be co-referential with the zero anaphor. While the candidates for the antecedent are only noun phrases in the same text in case of zero anaphora resolution, the title is also a candidate in our problem. In our system, the first stage is in charge of detecting the zero anaphor. In the second stage, antecedent search is carried out by considering the candidates. If antecedent search fails, an attempt made, in the third stage, to use the title as the antecedent. The main characteristic of our system is to make use of a structural SVM for finding the antecedent. The noun phrases in the text that appear before the position of zero anaphor comprise the search space. The main technique used in the methods proposed in previous research works is to perform binary classification for all the noun phrases in the search space. The noun phrase classified to be an antecedent with highest confidence is selected as the antecedent. However, we propose in this paper that antecedent search is viewed as the problem of assigning the antecedent indicator labels to a sequence of noun phrases. In other words, sequence labeling is employed in antecedent search in the text. We are the first to suggest this idea. To perform sequence labeling, we suggest to use a structural SVM which receives a sequence of noun phrases as input and returns the sequence of labels as output. An output label takes one of two values: one indicating that the corresponding noun phrase is the antecedent and the other indicating that it is not. The structural SVM we used is based on the modified Pegasos algorithm which exploits a subgradient descent methodology used for optimization problems. To train and test our system we selected a set of Wikipedia texts and constructed the annotated corpus in which gold-standard answers are provided such as zero anaphors and their possible antecedents. Training examples are prepared using the annotated corpus and used to train the SVMs and test the system. For zero anaphor detection, sentences are parsed by a syntactic analyzer and subject or object cases omitted are identified. Thus performance of our system is dependent on that of the syntactic analyzer, which is a limitation of our system. When an antecedent is not found in the text, our system tries to use the title to restore the zero anaphor. This is based on binary classification using the regular SVM. The experiment showed that our system's performance is F1 = 68.58%. This means that state-of-the-art system can be developed with our technique. It is expected that future work that enables the system to utilize semantic information can lead to a significant performance improvement.
Hwang, Keum Hee;Choi, Won Hee;Hu, Soo Jung;Lee, Hye young;Hwang, Kyung Mi
Journal of Food Hygiene and Safety
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v.36
no.1
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pp.34-41
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2021
The purpose of this research is to improve analysis methods of determining the contents of fatty acids in infant formulas and follow-up formulas. A gas chromatography (GC) method was performed on a GC system coupled to flame ionization detector, with a fused silica capillary column (SP2560, 100 m×0.25 mm, 0.20 ㎛). The method was validated using standard reference material (SRM, NIST 1849a). Performance parameters for method validation such as specificity, linearity, limits of detection (LOD) and quantification (LOQ), accuracy and precision were examined. The linearity of standard solution with correlation coefficient was higher than 0.999 in the range of 0.1-5 mg/mL. The LOD and LOQ were 0.01-0.06 mg/mL and 0.03-0.2 mg/mL, respectively. The recovery using standard reference material was confirmed and the precision was found to be between 0.8% and 2.9% relative standard deviation (RSD). Optimized methods were applied in sample analysis to verify the reliability. All the tested products had acceptable contents of fatty acids compared with component specification for nutrition labeling. The result of this research will provide efficient experimental information and strengthen the management of nutrients in infant formula and follow-up formula.
Nutrition label (NL) on the package of processed food provides consumers with a reliable and consistent source of information . It has been considered as a useful aid for food selection and a potent educational tool for nutrition in daily life. Since current nutrition labeling regulation in Korea does not define a format for presenting nutrition information a wide variety of NL format exists in the markers created by individual manufacturers. Development of standard NL format and its registration remain to be the work for the professionals and government officials. However the acceptance and evaluation of NL by the consumers is a very important and necessary process in the development of NL formats. In this study four different formats A, B, C, D were formulated based on currently circulating labels and new U.S.NL. Subjects used for evaluation of these formats were middle -aged highly educated housewives, who and the potential users of NL. Major parameters observed through the questionnare were their nutritional knowledge of RDA, ability of IC(Information Comparison) and CA (Comprehension and Application of informed nutrient contents), as well as their preference to the different formats. The results are summarized as follows. 1) Of the 178 subjects , 89.9% of the middleaged housewives were college graduates. Their nutrition knowledge of RDA were relatively satisfactory showing over 80% correlation on the basic concepts and unit while for numerical value less than 50% correct answer. 2) IC test scores were significantly different among the formats showing the highest values for format A and B which are presented as absolute value and % RDA, respectively. Format C presented as serving size(number of products) showed the lowest score. CA scores were also significantly different, though the increased load of information did not facilitate to increase the consumers comprehension. 3) RDA knowledge test scores and the scores of IA and CA were correlated in format A and D but not in format B and C suggesting % RDA presentation would be more acceptable to the less educated group. 4) For the preference in the aspects of easiness and time-saving format A was the best one then format D supporting the result of IC and CA test. The results of the present study indicate the most useful and preferred format is the simplest format presented as absolute value without RDA, . The secondly preferred format is the new NL format of the US with much information .
In Video Software Dealers Association v. Arnold Schwarzenegger, the federal 9th Circuit Court decided that a California law imposing restrictions and a labeling requirement on the sale or rental of violent video games to minors (the "Act") violated rights guaranteed by the First and Fourteenth Amendments to the United States Constitution because: (1) the state introduced insufficient evidence to support a compelling interest that video games created psychological or neurological harm, (2) the Act was not the least-restrictive alternative to negate the harm, and (3) the lower, rational basis standard applicable to commercial speech did not apply to the Act's labeling requirements because the required label did not convey factual information. On the contrary, Korean Constitutional Court decided that "Harmful Medium to Youth" and "Preliminary Rate Classification" would be constitutional. However, under the least-restrictive method rule of the U. S. Court and Korean Court, overlap application of "Harmful Medium to Youth" and "Preliminary Rate Classification" could be a problem and it would be possible that stronger regulation among these would be found as unconstitutional.
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