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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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