(343 days)
The Piezosurgery White is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:
• Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;
• Scaling applications, including:
– Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;
– Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning;
– Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and retrograde preparation;
– Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
The Piezosurgery White uses ultrasonic energy to generate mechanical micro-vibration of the available insert tips designed with different morphologies/shapes to perform the dental procedures defined in its intended use.
The Piezosurgery White consists of a table-top unit (console) containing the irrigation delivery system, the internal electric power supply, the ultrasonic generator, and the control keyboard.
The provided text is a 510(k) summary for a medical device called "Piezosurgery White." It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop system.
The device in question ("Piezosurgery White") is a surgical instrument that uses ultrasonic energy for bone cutting and other dental procedures. It is not an AI-powered diagnostic or assistive device that would typically involve acceptance criteria related to accuracy metrics (e.g., sensitivity, specificity, AUC), human reader performance, ground truth establishment by experts, or MRMC studies that are common for AI/ML medical devices.
The "Performance Data" section states:
"A features comparison and risk analysis of the modified devices was performed. The results demonstrate that the modifications do not alter the operating principle or mechanism of action of the inserts. The tuning frequency and vibration amplitude of each insert was evaluated via performance bench testing. The results demonstrated that the W1-W6 met the stipulated acceptance criteria and so are substantially equivalent to the predicate inserts."
This indicates that a bench test was performed to ensure the new inserts (W1-W6) met specific performance criteria (tuning frequency and vibration amplitude) to demonstrate substantial equivalence to existing inserts for a physical surgical device.
Therefore, I cannot extract the requested information from the provided text because the device and the nature of its evaluation are different from what the prompt is asking about (which seems to be tailored towards AI/ML device performance studies).
§ 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.