(123 days)
TRAUS SUS10, Piezo Surgery and Implant Engine Unit, is intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation (for ultrasonic surgery), and implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation (for dental implant surgery).
TRAUS SUS10, Piezo Surgery and Implant Engine Unit, combines the function of piezo surgery by using ultrasonic mechanical vibration and the function of dental implant motor surgery into one device. TRAUS SUS10 includes a control box (main unit), foot controller and dental handpieces. The dental handpieces of TRAUS SUS10 are supplied with two types: Piezo handpiece and Dental implant motor handpiece incorporating an implant motor and an angle handpiece. When the AC power is connected to the control box by the power cord, the control box has a program for ultrasonic surgery mode which be able to select options such as power (output intensity) and boost (vibration frequency), and for implant motor surgery mode which be able to select options such as speed, torque and gear ratio, and includes the memory function for input and output settings.
The provided text does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI-powered medical device. Instead, it is a 510(k) premarket notification for a medical device called "TRAUS SUS10 Piezo Surgery and Implant Engine Unit," which is a dental surgery device.
The document discusses:
- The device's intended use and technological characteristics.
- Comparison to predicate devices to establish substantial equivalence.
- Non-clinical test summaries covering electrical safety, EMC, software validation, biocompatibility, sterilization validation, and mechanical performance testing.
- A explicit statement that "No clinical studies were considered necessary and performed."
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them, as the provided text does not describe such a study or and the device is a piece of surgical equipment, not an AI or software-only device.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.