Effect and Safety of Smart Bra (PUMCH)

This study is a randomized, open, multicenter clinical study. It will be conducted in Peking Union Medical College Hospital, Shanxi Provincial People's Hospital, Beijing Third Hospital, Zhalantun ZhongMeng hospital, Chongqing Medical University affiliated university town hospital, Shenzhen People's Hospital and other national hospitals. A total of 2000 subjects are expected to participate. The patients in the group wore the device for about 3 minutes, and took photos of 5 breast sites. After that, the artificial intelligence learning was carried out on the photos of the training group. For the photos of the verification group, the algorithm obtained by the training group was compared with the existing artificial intelligence algorithms of ultrasound and molybdenum target. During the follow-up, the safety of the product was evaluated. According to the basic principles of safety and performance of who international general GHTF (sg1-n020r5) medical devices.

Inclusion criteria

• Patients who are going to receive breast ultrasound and molybdenum target in breast surgery clinic;
• Female patients (18-80 years old);
• Signed written informed consent approved by the relevant institutional review board (IRB) or independent ethics committee (IEC)

Exclusion criteria

• The subjects were pregnant or lactating;
• Patients with nipple discharge;
• Known allergy to bra materials;
• The patients who had received breast surgery or breast puncture within half a year;
• Patients with skin diseases.