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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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The OpuDuo 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, and enamel etching.

The CO2 laser component is indicated for vaporization, excision and coagulation of oral soft tissue in procedures such as gingivectomy; frenum release; removal of soft tissue, cysts and tumors.

The Opus Spectrum c is a model of the Opus 20 Dental Laser System which is intended to aid during dental procedure performed either in hard or soft oral tissue. This is a dual laser system incorporating an Er: Y AG 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.

This document is a 510(k) summary for the Opus Spectrum dental laser system. It states that the Opus Spectrum is an improved model of the Opus 20 dental laser system and is substantially equivalent to the Opus 20. However, this document does not contain information about acceptance criteria or specific studies proving the device meets those criteria.

The "Design Control Activities Summary" section mentions that "identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied are presented in Sections 6 and 8 of this submission." However, Sections 6 and 8 are not included in the provided text.

Therefore, I cannot provide the requested information.

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The Opus 10TM Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening.

The Indications for Use of the Opus 10™ Dental Diode Laser System include:

Cosmetic Dentistry

• Light activation for bleaching materials for teeth whitening
• Laser-assisted bleaching/whitening of the teeth

Endodontology

• Pulpotomy
• Pulpotomy as an adjunct to root canal therapy

Periodontology

• Sulcular debridement (removal of diseased or inflamed soft tissue in the periodental pocket)
  Oral Soft Tissue Surgery
• Biopsy
• Operculectomy
• Gingivectomy
• Gingivoplasty
• Papillectomy
• Lesion (tumor) removal
• Leukoplakia
• Treatment of aphthous ulcers
• Fibroma removal
• Frenectomies and frenotomies
• Tissue retraction for impressions
• Incising and draining of abscesses
• Exposure of unerupted teeth

The Opus 10TM Dental Diode Laser is designed to perform several medical procedures in the oral soft tissue and to perform laser assisted aesthetic tooth whitening procedures.

A Gallium Aluminum Arsenide (GaAIAs) solid state laser diode provides optical energy to oral soft tissues.

A fiber optic held by an handpiece delivers the Opus 10™ laser energy. A visible light emitted from the handpiece's distal end targets the area of treatment. The optical power output and pulse may be adjusted to specific use requirements.

The provided text is a 510(k) Summary for the Opus 10TM Dental Diode Laser System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with specific acceptance criteria as you would find for a de novo submission or a PMA.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, or comparative effectiveness studies in the way you've outlined. The device is not an AI/ML device, and thus those types of studies would not be applicable.

However, I can extract the relevant information regarding how the device's performance and safety were demonstrated for its substantial equivalence claim, aligning with the spirit of your request as much as possible for this type of document.

Here's a breakdown of what the document does provide:

1. Acceptance Criteria and Reported Device Performance:
   • This document doesn't list specific quantitative acceptance criteria (e.g., ≥ X% sensitivity) or reported performance metrics (e.g., "The device achieved Y% sensitivity").
   • Instead, the "acceptance criteria" are implied by compliance with regulatory and voluntary standards, and by demonstrating substantial equivalence to predicate devices in terms of technological characteristics, performance, intended use, and indications for use.
   • "Reported Device Performance" in this context refers to its ability to meet the general performance expectations of the predicate devices and comply with relevant standards.

2. Sample size used for the test set and the data provenance: Not applicable. This 510(k) summary does not describe a clinical study with a "test set" in the context of an FDA clearance for an AI/ML device. The "testing" referred to is against engineering and safety standards, and comparative analysis to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no "test set" or ground truth established in the sense of an AI/ML algorithm evaluation. The document states that the predicate devices have "proven safety and effectiveness," implying prior regulatory review.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser system, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For the purposes of this 510(k), the "ground truth" for proving substantial equivalence lies in the established performance and safety of the predicate devices and compliance with recognized standards. There isn't a "ground truth" in the diagnostic sense (e.g., pathology, outcomes data).

8. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set in that context.

9. How the ground truth for the training set was established: Not applicable.

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