LEADER 00962nam0 22002531i 450 001 UON00149057 005 20231205102914.185 100 $a20020107d1874 |0itac50 ba 101 $ager 102 $aDE 105 $a|||| 1|||| 200 1 $aAbhandlungen zur geschichte des Orients im alterthum$fHeinr. Brandes 210 $aHalle$cLippert'sche Buchhandlungen$d1874 215 $a150 p.$d25 cm 620 $dHalle$3UONL000424 686 $aVOA IV$cVICINO ORIENTE ANTICO - STORIA$2A 700 1$aBRANDES$bHeinr.$3UONV089221$0672639 712 $aLippert$3UONV264354$4650 801 $aIT$bSOL$c20240220$gRICA 899 $aSIBA - SISTEMA BIBLIOTECARIO DI ATENEO$2UONSI 912 $aUON00149057 950 $aSIBA - SISTEMA BIBLIOTECARIO DI ATENEO$dSI RARI VOA IV 004 $eSI MR 28239 7 004 996 $aAbhandlungen zur geschichte des Orients im alterthum$91276234 997 $aUNIOR LEADER 04392nam 22005895 450 001 9910717423803321 005 20251008163716.0 010 $a9783031261398$b(electronic bk.) 010 $z9783031261381 024 7 $a10.1007/978-3-031-26139-8 035 $a(MiAaPQ)EBC7240878 035 $a(Au-PeEL)EBL7240878 035 $a(DE-He213)978-3-031-26139-8 035 $a(OCoLC)1377818210 035 $a(PPN)269660461 035 $a(CKB)26516386600041 035 $a(EXLCZ)9926516386600041 100 $a20230424d2023 u| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aStatistical Methods and Analyses for Medical Devices /$fby Scott A. Pardo 205 $a1st ed. 2023. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2023. 215 $a1 online resource (384 pages) 311 08$aPrint version: Pardo, Scott A. Statistical Methods and Analyses for Medical Devices Cham : Springer International Publishing AG,c2023 9783031261381 320 $aIncludes bibliographical references and index. 327 $a1. Some Fundamentals ? Probability -- 2. Some Fundamentals ? Estimation and Inference -- 3. Confidence -- 4. Power and Hypothesis Testing -- 5. Least Squares: Regression and ANOVA -- 6. Product Design ? Factorial Experiments -- 7. Process Control -- 8. Inspection and Acceptance Sampling -- 9. Shelf Life, Stability, Reliability, Time-to-Event -- 10. Diagnostics: Sensitivity and Specificity -- 11. Equivalence and Noninferiority -- 12. Nonparametrics -- 13. Bayesian Methods -- 14. Prediction, Classification, Non-Linear Modeling -- 15. Variance Components and Precision -- 16. Time Series and Dynamic Systems -- 17. Odds, Odds Ratios, and Comparing Proportions -- 18. Afterword. 330 $aThis book provides a reference for people working in the design, development, and manufacturing of medical devices. While there are no statistical methods specifically intended for medical devices, there are methods that are commonly applied to various problems in the design, manufacturing, and quality control of medical devices. The aim of this book is not to turn everyone working in the medical device industries into mathematical statisticians; rather, the goal is to provide some help in thinking statistically, and knowing where to go to answer some fundamental questions, such as justifying a method used to qualify/validate equipment, or what information is necessary to support the choice of sample sizes. There are no statistical methods specifically designed for analysis of medical device data. However, there are some methods that seem to appear regularly in relation to medical devices. For example, the assessment of receiver operating characteristic curves is fundamental to development of diagnostic tests, and accelerated life testing is often critical for assessing the shelf life of medical device products. Another example is sensitivity/specificity computations are necessary for in-vitro diagnostics, and Taguchi methods can be very useful for designing devices. Even notions of equivalence and noninferiority have different interpretations in the medical device field compared to pharmacokinetics. It contains topics such as dynamic modeling, machine learning methods, equivalence testing, and experimental design, for example. This book is for those with no statistical experience, as well as those with statistical knowledgeable?with the hope to provide some insight into what methods are likely to help provide rationale for choices relating to data gathering and analysis activities for medical devices. 606 $aStatistics 606 $aBiometry 606 $aMathematical statistics$xData processing 606 $aStatistics 606 $aBiostatistics 606 $aStatistics and Computing 615 0$aStatistics. 615 0$aBiometry. 615 0$aMathematical statistics$xData processing. 615 14$aStatistics. 615 24$aBiostatistics. 615 24$aStatistics and Computing. 676 $a780 676 $a610.284 700 $aPardo$b Scott A.$0755901 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 912 $a9910717423803321 996 $aStatistical Methods and Analyses for Medical Devices$93355588 997 $aUNINA