(14 days)
The Ceralas D10 Laser System that is the subject of this 510(k) notice is intended for the following dental indications on intraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva): frenctomy, frenotomy, biopsy, operculectorny, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy and pulpotomy as an adjunct to root canal therapy.
The Ceralas DlO Diode laser is indicated for the following dental indications on intraoral and extraoral soft tissue (including marginal and interdental gingiva : and epithelial lining of free gingiva); frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor sites, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, and pulpotomy as an adjunct to root canal therapy.
The Cerals D10 Diode Laser operates with a power range of 1-10W in the CW or pulsed mode. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end.
The provided 510(k) submission for the Ceralas D10 Diode Laser System states "None required" for "Performance Data." This indicates that the device's acceptance criteria were not established through a specific performance study in this submission, but rather through a claim of substantial equivalence to a predicate device. Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document.
However, based on the provided text, here's what can be stated:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document explicitly states "Performance Data: None required." The acceptance was based on substantial equivalence to a predicate device, not on specific performance metrics demonstrated in a study for this device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No performance study was conducted.
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. No performance study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No performance study was conducted.
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 diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No performance study requiring ground truth was conducted for this device.
8. The sample size for the training set
Not applicable. No performance study involving a training set was conducted for this device.
9. How the ground truth for the training set was established
Not applicable. No performance study involving a training set was conducted for this device.
Explanation from the document:
The 510(k) submission explicitly states:
- "Performance Data: None required."
- "There are no technological differences between the Ceralas D10 Laser System and the Premier Laser Systems Aurora Diode Laser.. The Ceralas D10 Laser System's principles of operation, function and intended use are similar to Premier Laser System's Aurora Diode Laser System and no new questions of safety or effectiveness are raised."
This indicates that the FDA's acceptance of the Ceralas D10 Diode Laser System was based on its substantial equivalence to the legally marketed Premier Laser System's Aurora Diode Laser, meaning it operates on the same principles and has the same intended use, and therefore, no new performance data or separate clinical studies were deemed necessary for this specific submission.
§ 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.