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Root Canal Disinfection

• Laser root canal disinfection after endodontic instrumentation

The Waterlase® !Waterlase® MD dental laser system is a device used to perform a variety of dental soft and hard tissue indications. For hard tissue procedures the Waterlase® Waterlase MD uses the Erbium, Chromium: Yttrium, Scandium, Gallium Garnet (Er,Cr.YSGG) laser in combination with advanced water atomization spray technology to cut, remove, shave, contour, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er, Cr. YSGG laser energy is applied to incise, excise or ablate these tissues. For soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues and the field of view clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping tissues and field of view clean.
A flexible fiberoptic terminated into the handpiece delivers the Waterlase Waterlase MD laser energy to the end fiber tip and target. As visible aiming light emitted from the handpiece's distal end pinpoints the area of treatment.
Three fiber optic ports provide illumination from the handpiece to the tissue site in addition to the center beam emitting source. In both hard and soft tissue applications the power output, pulse duration, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. The spot size and spot geometry can also be varied by changing tips which include different diameters and end configurations.

The provided text describes a 510(k) summary for the Waterlase® and Waterlase® MD dental laser systems, seeking to expand their indications for use to include root canal disinfection. However, the document does not contain specific acceptance criteria, reported device performance metrics in a defined study, or the details typically associated with such studies as requested in the prompt.

Instead, it refers to "performance data, including in-vitro evaluation of anti-microbial efficacy of the Er,Cr:YSGG (Waterlase®) and the evaluation of the temperature rise which related to the safety of these devices during root canal disinfection." It states that "Copies of the study reports are included under section 8, titled Performance Data." This section ("Performance Data") is not provided in the given text extract.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor the detailed study information using only the provided text.

Based on the available text, I can extract the following limited information:

• Study Types Mentioned (but not detailed):
  • In-vitro evaluation of anti-microbial efficacy of the Er,Cr:YSGG (Waterlase®)
  • Evaluation of temperature rise related to safety during root canal disinfection.
• Purpose of the Studies: To substantiate equivalency for the expanded indication of root canal disinfection.
• Ground Truth for these studies (implied based on stated purpose):
  • For anti-microbial efficacy: Likely microbiological assays measuring bacterial reduction.
  • For temperature rise: Likely direct temperature measurements in a simulated root canal environment.

All other requested information (acceptance criteria, specific performance metrics, sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided 510(k) summary.

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