(142 days)
Dental Soft Tissue Indications Including Pulpal Tissues*: Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectorny, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscesses, Leukoplakia, Operculectormy, Oral papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, and Vestibuloplasty. *For use on adult and pediatric patients. Laser Periodontal Procedures: Laser soft tissue curettage, Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, 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). Tooth Whitening: Laser assisted whitening/bleaching of teeth, Light activation for bleaching materials for teeth whitening.
The Claros Dental Laser System is a portable laser that uses a gallium aluminum arsenide 810 nm diode laser module to provide optical energy via a contact fiber optic delivery system. Claros is used for multiple soft tissue. periodontal, and teeth whitening applications. The Claros Dental Laser System is comprised of the following main components: a light/ laser system console (including software, a display panel and controls); delivery devices: one or more handpieces; key cards for security; and protective eve wear.
The provided text is a 510(k) summary for the Claros® Dental Laser System. It focuses on establishing substantial equivalence to a predicate device by comparing indications for use, principles of operation, and technical capabilities.
Crucially, the document does not contain information about acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), or any studies that would prove the device meets such criteria.
The "Performance Data" section only lists compliance with various electrical and laser safety standards (IEC 60601-1, IEC 60601-2-22, IEC 60825-1, 21 CFR 1040.10 and 1040.11, and the European Medical Device Directive 93/42/EEC). These are general safety and performance standards for laser devices, not clinical efficacy or diagnostic performance metrics.
Therefore, I cannot provide the requested information from the given text.
To answer your specific questions, based solely on the provided text:
- A table of acceptance criteria and the reported device performance: Not available.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available.
- 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 available. This device is a surgical laser, not an AI-powered diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available. This device described is a physical laser system, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.