(126 days)
The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used for dental cleaning and removal of tenacious calculus and plaque using ultrasonic vibration. The last 4.3 mm of the insert tip vibrates ultrasonically to remove the tenacious calculus from the teeth.
The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used to remove tenacious calculus and plaque by ultrasonic vibrations. When place inside the handpiece, the ultrasonic insert is exposed to a varying magnetic field created by a unique pattern of copper wiring wrapping the plug of the handpiece. The varying magnetic field causes the insert "stack" of the metal tips to contract and expand, thus resulting in insert tip vibration in an elliptical motion. The water supply in the insert washes away the debris and cools the insert tip. The distal 4.3 mm portion of the insert tip is affected by the frequency of 25,000 to 30,000 Hz and performs the instrumentation. The tips are offered in two frequencies, six different colors and twenty different tip styles.
The provided text is a 510(k) summary and FDA clearance letter for the Insight Ultrasonic Inserts. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.
The document is a regulatory submission focused on demonstrating substantial equivalence to already cleared devices, rather than presenting a performance study with detailed acceptance criteria and study data as one might find for a novel device requiring more rigorous clinical validation.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance using the provided input, nor can I answer the specific questions about sample sizes, expert qualifications, or study methodologies because this information is not present in the text.
The document indicates that the device is "substantially equivalent" to predicate devices, implying that its performance is expected to be similar to those devices without necessarily undergoing a new performance study against explicit acceptance criteria in this specific submission.
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.