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For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.
Examples:
Excisional and incisional biopsies
Exposure of unerupted teeth
Fibroma removal
Frenectomy and frenotomy
Gingival troughing for crown impressions
Gingivectomy
Gingivoplasty
Gingival incision and excision
Hemostasis
Implant recovery
Incision and drainage of abscess
Leukoplakia
Operculectomy
Oral papillectomies
Pulpotomy
Pulpotomy as an adjunct to root canal therapy
Reduction of gingival hypertrophy
Soft tissue crown lengthening
Sucular 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)
Treatment of aphthous ulcers
Vestibuloplasty
Biopsy incision and excision
Lesion (tumor) removal

For light activation for bleaching materials for teeth whitening For laser-assisted bleaching/whitening for teeth.

Not Found

The provided text is a 510(k) Summary for the DioDent II Dental Laser System. It explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None."

Therefore, based on the provided input:

1. A table of acceptance criteria and the reported device performance:
There are no acceptance criteria or reported device performance data provided in the document.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No sample size, test set, or data provenance information is provided as no clinical performance data was submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no clinical performance data was submitted, and therefore no ground truth establishment was described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical performance data was submitted.

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 dental laser system, not an AI-assisted diagnostic tool. No comparative effectiveness study of this nature was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a dental laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no clinical performance data was submitted.

8. The sample size for the training set:
Not applicable, as no clinical performance data was submitted and this device is not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established:
Not applicable, as no clinical performance data was submitted and this device is not an AI/ML algorithm.

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