How to confirm that the effectiveness of the test device is equivalent to that of the control device

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

Probability of making the right decision to reject the null hypothesis if the alternative hypothesis is true

How to confirm that the effectiveness of the test device is not inferior to the control device.

How to check the superiority of test equipment over control equipment.

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.

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.

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.

The presence or absence of a disease to be diagnosed or predicted or the result of diagnosis of a specific condition.

Method of assigning subjects to different treatment groups (2 groups or 3 or more groups ) Divided into test group and control group.

Data used in machine learning to diagnose, manage, or predict disease.

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.

Criteria that accurately represent the purpose of the clinical trial.

Biometric information measured from medical records or medical devices, medical images , genetics Various information used to diagnose, manage, or predict a disease.

Provides virtualized information technology (IT) resources as a service using Internet technology Computing.

The presence or absence of a disease to be diagnosed or predicted or the result of diagnosis of a specific condition.

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.