A Single-Center, Randomized, Crossover, Prospective, Open-Label, Non-Inferiority Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of an AI- and Ultrasound-Based Medical Device That Assists Venipuncture, Compared With Manual Venipuncture

Inclusion Criteria

Inclusion Criteria: * Male or female adults aged 19 years or older at the time of study enrollment. * Subjects who are able to undergo venipuncture in the antecubital area of both arms, without restriction of elbow joint movement, and who can maintain the arm in a stable extended position during venipuncture. * Subjects who have received a full explanation of the clinical trial, fully understand the contents, voluntarily decide to participate, and provide written informed consent prior to screening procedures. Exclusion Criteria: * Pregnant or breastfeeding women. * Subjects with an implanted defibrillator or pacemaker. * Subjects at increased risk of bleeding due to underlying conditions such as anticoagulant use, hemophilia, thrombocytopenia, preeclampsia, or other coagulation disorders. * Subjects with abnormal vascular anatomy in the antecubital area due to vascular malformations, vascular disease, or prior creation of an arteriovenous shunt. * Subjects with significant abnormal skin lesions (e.g., infection, dermatologic disease, trauma, or wounds) in the antecubital area. * Subjects whose arm condition is unsuitable for venipuncture due to transfusion, intravenous fluid therapy, or similar procedures. * Subjects with immunodeficiency or immunosuppression (e.g., steroid or immunosuppressant therapy, severe infection) and therefore vulnerable to infection. * Subjects with a prior history of severe vasovagal reaction during venipuncture. * Subjects whose upper arm circumference exceeds 44 cm, preventing application of the tourniquet inside the device. * Subjects with a conflict of interest, such as employees of competing companies. * Subjects considered by the investigator to be otherwise unsuitable for participation in this clinical trial.