(77 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, Operculectomy, Oral papillectornies, 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. 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 nano Dental Laser System is a variant of the Claros Dental Laser System. It 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 nano is used for multiple soft tissue, periodontal, and teeth whitening applications. The Claros nano 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; and protective eye wear.
The provided text covers a 510(k) summary for the Claros nano Dental Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria for the device itself in terms of clinical effectiveness metrics.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, training set size and ground truth) are not available in the provided text.
Here's a summary of what can be extracted or inferred from the text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as performance metrics tied to specific values. Instead, the primary "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to existing legally marketed devices.
- Reported Device Performance: The device is stated to comply with several international and US standards related to medical electrical equipment safety, laser safety, and radiation control.
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance (Compliance) |
|---|---|
| Substantial Equivalence to Predicate Devices | - Shares same/similar indications for use |
| - Shares same/similar principles of operation | |
| - Shares same/similar overall technical and functional capabilities | |
| - Does not raise new safety or effectiveness issues | |
| Compliance with relevant standards | - IEC 60601-1:1988+A1:1991+A2:1995 |
| - IEC 60601-2-22:1995 | |
| - IEC 60825-1:1993+A1:1997+A2:2001 | |
| - 21 CFR 1040.10 and 1040.11 |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable / Not Provided. The submission is focused on technical specifications and substantial equivalence, not a clinical trial with a defined test set for performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Provided. There is no mention of a test set with ground truth established by experts.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided.
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
- No. This is a hardware device (laser system), not an AI-powered diagnostic or assistance tool. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant and not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. As noted above, this is a laser and not an algorithm.
7. The Type of Ground Truth Used
- Not Applicable / Not Provided. There is no mention of ground truth in the context of device performance in the provided text.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. This is a hardware device submission, not a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established
- Not Applicable / Not Provided. This is a hardware device submission, not a machine learning algorithm.
§ 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.