Crossover design
A method of applying both the test device and the control device to one subject. In the case of the test equipment priority application group, use the test equipment first and How to use the control device after passing everything.
Equivalence test
How to confirm that the effectiveness of the test device is equivalent to that of the control device
Randomization
Subjects to each treatment group according to the principle of probability to reduce selection bias. Assignment process Bar . Non-inferiority test How to confirm that the effectiveness of the test device is not inferior to the control device Page 9 – 4 – Four . Superiority test How to check the superiority of test equipment over control equipment
Power
Probability of making the right decision to reject the null hypothesis if the alternative hypothesis is true
Non-inferiority test
How to confirm that the effectiveness of the test device is not inferior to the control device.
Superiority test
How to check the superiority of test equipment over control equipment.
Artificial Intelligence (AI)
Some or all of human intellectual ability ( intelligence ) such as cognition and learning Technology implemented through machine learning, etc. Now, Medical devices with big data and artificial intelligence technology applied Analyze medical big data with artificial intelligence technology to diagnose or manage diseases Medical devices that predict and assist medical personnel.
Clinical Trials Review Committee (Institutional Review Board, IRB)
Sample Data
Subject’s medical data acquired through previous treatment or clinical trials ( Medical imaging, biological signals , pathology , the genetic information and the like ) in a clinical trial to Subject replacing the subject.
Prospective clinical trial
After setting the factors to be studied in advance, changes are tracked over a period of time. A clinical trial that observes changes caused by risk factors with a research method.
Reference standard
The presence or absence of a disease to be diagnosed or predicted or the result of diagnosis of a specific condition.
Parallel design
Method of assigning subjects to different treatment groups (2 groups or 3 or more groups ) Divided into test group and control group.
Training Data
Data used in machine learning to diagnose, manage, or predict disease.
Retrospective clinical trial
Research conducted without direct contact with the subject Of subjects acquired through previous treatment or clinical trials instead of recruiting subjects Medical data (medical records , medical images , biological signals , pathology tests , genetic information, etc.) Sample data ) to verify the safety and effectiveness of medical devices.
Primary efficacy criteria
Criteria that accurately represent the purpose of the clinical trial.
Medical Big Data
Biometric information measured from medical records or medical devices, medical images , genetics Various information used to diagnose, manage, or predict a disease.
Cloud computing
Provides virtualized information technology (IT) resources as a service using Internet technology Computing.
Reference Standard
The presence or absence of a disease to be diagnosed or predicted or the result of diagnosis of a specific condition.
Machine Learning
Machine learning-based big data and medical devices with artificial intelligence technology. Medical software used to analyze and detect existing medical images or assist diagnosis. Unlike the diagnosis, the user or manufacturer can reflect the learning data. Algorithm can be changed in real time, and cloud computing technology is applied to the medical institution itself or an external cloud server through the network. Data can be stored or used.
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