Search Results

The Sonendo GentleWave(R) System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave Molar Handpiece, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo Gentle Wave Anterior Premolar Handpiece, the System is indicated for anterior and premolar teeth.

The Sonendo GentleWave® System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo GentleWave® System is comprised of a Console, and a disposable single-use Handpiece. The Handpiece is offered in two versions: a Molar Handpiece which is intended to be used on 1st and 2nd molar teeth and an Anterior/Premolar Handpiece which is intended to be used on anterior and pre-molar teeth.

The provided text is a 510(k) summary for the Sonendo GentleWave System, seeking to demonstrate substantial equivalence to a previously cleared predicate device (K160905). This document does not describe an artificial intelligence (AI) or machine learning (ML) device, nor does it detail a study involving human experts validating AI performance.

Therefore, I cannot extract the information required to answer your prompt, as the prompt's assumptions (acceptance criteria for AI, ground truth establishment by experts for AI, MRMC studies for AI, standalone AI performance) are not applicable to the content of this document.

The document discusses performance data related to:

• Root Canal Cleaning Efficacy
• Apical Pressure
• Sterilization (Sterility Assurance)

These tests are for the physical device's function, not for an AI algorithm's diagnostic or analytical performance.

Ask a specific question about this device