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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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The OpusDuo EC Dental Laser System is intended to aid during dental procedures performed either in hard or soft oral tissue.
The Er: YAG laser component is indicated for caries removal, cavity preparation, enamel etching and the, incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacia! surgery and dentistry. These include the following:
Soft tissue and periodontal indications: Excisional and incisional biopsies; Exposure of unerupted teeth; Incision and drainage of abscesses; Gingival incision and excision; Gingivoplasties; Gingivectomies, Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias; Gingival troughing for crown impressions; Hemostasis; Implant recovery; Frenectomies and frenotomies; Fibromatosis (fibroma removal); Benign and malignant lesion removal; Operculectomy; Oral papillectomies; Reduction of gingival hypertrophy; Soft tissue crown lengthening; Preprosthetic surgery; flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasias, epulides, papilomas, fibromatoses, benign growths; Vestibuloplasty; Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
Endodontal Applications: Tooth preparation to obtain access to root canal; Pulpotomy; Pulp extirpation; Pul potomy as an adjunct to root canal therapy; Root canal debridement and cleaning; Root canal preparation including enlargement
The CO2 laser component is indicated for periodontal procedures such as removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement) and vaporization, excision coagulation and ablation of oral soft tissue in procedures such as gingivectorny; frenum release; removal of soft tissue, cysts and tumors.

The OpusDuo EC is a model of the Opus 20 Dental Laser System, which is intended to aid during dental procedures performed either in hard or soft oral tissue. This is a dual laser system incorporating an Er:YAG laser and a CO2 laser. The system is operating at a wavelength of 2.94 microns and 10.6 microns respectively. The Er: YAG laser delivers to the tissue pulses with energies up to 1 joule per pulse and power up to 12 Watts. The CO2 laser delivers to the tissue power in continuous mode (CW) up to 10 Watts and pulses (SP) up to 6 Watts.

The provided text is a 510(k) Summary for the OpusDuo EC Dental Laser System, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics. As such, it does not contain the information required to populate a table of acceptance criteria and reported device performance directly from a study.

The document primarily relies on comparing the device's technical characteristics, intended use, and indications for use to previously cleared devices. It states that "The OpusDuo EC intended use and indications for use were previously cleared by FDA for the predicate devices" and that the "technical characteristics... are basically the same as those of the cleared..." predicate devices. It also mentions that "Laser output values of the OpusDuo EC are well within previous cleared values of the predicate devices as described."

The closest the document comes to mentioning performance criteria and validation is:

• Performance Standards: The device complies with U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products, and voluntary standards EN 60601-1, EN 60601-1-2, EN-601-2-22, EN-60825-1, CISPR 11: 1997, class B and IEC 61000-4-2/3/4/5: 1995, EMI -EN55011 :1991, IEC 801:1991. These standards cover aspects like electrical safety, electromagnetic compatibility, and laser safety features (interlock protective housing, laser emission indicators, etc.).
• Validation Testing: "Validation testing has confirmed that the design of the additional accessories, which are required for the new applications, satisfies their technical specification." This indicates accessory validation, not necessarily the clinical or diagnostic performance of the laser system itself for its stated indications.

Given this context, I cannot generate the requested table and detailed study information as it is not present in the provided text. The document's purpose is to establish substantial equivalence for market clearance, not to detail a clinical performance study with acceptance criteria, ground truth, and expert adjudication.

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