(232 days)
Dental Soft Tissue Indications for: 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 Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakja Operculectomy 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 ulccrs of the oral mucosa. Vestibuloplasty. Laser Periodontal procedures, including: 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, infected, inflamed and necrosed 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 Indications: Laser assisted whitening/bleaching of teeth. Light activation for bleaching materials for teeth whitening.
The LaserSmile™ dental diode laser system may be used to perform several dental applications. LaserSmile™ uses advanced laser technology to incise, excise and ablate intraoral soft tissues and to activate a bleaching material for whitening/bleaching teeth safely and effectively. A Gallium Aluminum Arsenide (GaAlAs) solid state laser diode provides optical energy to oral soft tissues and tooth bleaching compounds. A flexible fiberoptic handpiece delivers the LaserSmile™ laser energy. A visible light emitted from the handpicce distal end pinpoints the area of treatment. The optical power output and pulse may be adjusted to specific user requirements.
The provided text explicitly states that the LaserSmile™ device's substantial equivalence was demonstrated through "Equivalent performance specification", "Equivalent intended use", and a "Feature comparison table". However, it does not include any specific acceptance criteria or details of a study that proves the device meets such criteria in terms of quantitative performance metrics.
Instead, the submission relies on the concept of substantial equivalence to previously cleared devices (BioLase Technology, Inc. Waterlase® and Twilite™). This means that the manufacturer is asserting that their device is as safe and effective as a legally marketed predicate device, and therefore does not require new, extensive clinical performance studies to prove its efficacy.
Based on the provided document, here's what can be extracted:
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A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria with quantitative performance metrics for the LaserSmile™ device. The basis for acceptance is stated as "Equivalent performance specification" to predicate devices, but no specifics are given. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set or clinical study data is provided for the LaserSmile™ device itself. The claim of equivalence is based on the device's technical specifications and intended use being similar to already cleared devices. -
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 test set requiring expert ground truth establishment is described for the LaserSmile™ device. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication process is described. -
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 MRMC study was done. The device described is a dental laser, not an AI-assisted diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a medical device (dental laser), not an algorithm. Performance is demonstrated through equivalence to other devices. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No new clinical study data with ground truth is presented for the LaserSmile™ device to establish its performance. The "ground truth" for its acceptance is implicitly the established safety and efficacy of the predicate devices it claims substantial equivalence to. -
The sample size for the training set:
Not applicable. This is a hardware medical device, not a machine learning algorithm. -
How the ground truth for the training set was established:
Not applicable. This is a hardware medical device, not a machine learning algorithm.
Summary of Acceptance Basis:
The LaserSmile™ device was approved based on substantial equivalence to previously cleared dental laser devices (BioLase Technology, Inc. Waterlase® and Twilite™). The rationale for acceptance rests on:
- Equivalent performance specification: The technical specifications and operational parameters of LaserSmile™ are considered comparable to those of the predicate devices.
- Equivalent intended use: The specific dental soft tissue and tooth whitening indications for LaserSmile™ are identical to indications already cleared for the predicate devices.
- Feature comparison table: Although not provided in the excerpt, a comparison table would have been submitted to FDA to highlight the similarities between LaserSmile™ and the predicate devices.
The document implicitly states that no new clinical performance studies were deemed necessary because the device does not present unique applications, indications, materials, or specifications that differ significantly from its predicates.
§ 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.