(88 days)
The Piezotome™ device is a bone cutting instrument intended for use in oral surgery.
The Piezotome™ is a bone cutting instrument intended for use in oral surgery.
The Piezotome™ device uses piezoelectric ultrasound technology to generate mechanical microvibrations for bone cutting, with minimal trauma to soft tissue, The device is supplied with bone surgery, sinus lift, and ligament cutting tips for use in dental surgery, including osteotomy, osteoplasty, periodontal surgery, and implantology.
This device is fitted with two handpiece cord connectors. Depending on the application, the practitioner may connect two handpieces at the same time.
The Piezotome™ function offers four utilization modes at pre-set ultrasound power settings.
The user regulates the flow rate of the irrigation fluid,
The practitioner controls the device using a keyboard and a multi-function footswitch.
The irrigation fluid flow rate and the ultrasound power are monitored on a screen. For enhanced efficacy, the last settings are memorized by the machine.
The provided text is a 510(k) Summary for a medical device called the Piezotome™. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain acceptance criteria, a study proving the device meets those criteria, or any of the detailed study information regarding sample sizes, ground truth establishment, or expert involvement that you've requested.
The FDA's 510(k) clearance process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials that define and meet specific performance acceptance criteria like those often seen for novel devices or PMAs.
Therefore, I cannot fulfill your request with the provided input because the necessary information is not present in the document. The document confirms that the device is substantially equivalent to a predicate, meaning its safety and effectiveness are considered to be at least as good as the predicate device, but it doesn't detail a specific study with acceptance criteria.
§ 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.