(81 days)
This device may be used for the following indications:
- Light activation for bleaching materials for teeth whitening
- Laser-assisted whitening/bleaching of teeth
The exlase™ dental diode laser system is currently used to perform various and The system uses advanced laser technology to dealer with a many and the Samment works of the Mas An Indium Gallium Arsenide Phosphorus solid-state laser diode emits infrared laser energy to the various oral soft tissues targeted during procedure. This energy is transmitted via a flexible fiberoptic cable to the handpiece that emits the energy to the targeted tissue site. A visible light is emitted at the same time to visually pinpoint the treatment location. The power output and pulse width may be adjusted to specific user requirements.
The provided document is a 510(k) summary for the ezlase™ dental diode laser system, seeking to expand its indications for use to include teeth whitening. This type of regulatory submission often focuses on demonstrating substantial equivalence to predicate devices rather than presenting novel clinical study data with detailed acceptance criteria and performance metrics in the way a new, high-risk device might.
Based on the document provided, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define specific performance-based acceptance criteria for teeth whitening (e.g., a certain percentage improvement in shade, or a specific safety profile outcome) that the ezlase™ device was tested against. Instead, the "acceptance criteria" appear to be based on the principle of substantial equivalence to already cleared predicate devices for the same indications.
- Acceptance Criteria (Implied): Substantial equivalence to predicate devices for the indications of "Light activation for bleaching materials for teeth whitening" and "Laser-assisted whitening/bleaching of teeth," demonstrated by similar principles of operation, technology, and intended use as devices already cleared by the FDA for these indications.
- Reported Device Performance: The document states, "The indications requested by this 510(k) are the same as those previously cleared by the FDA for other equivalent devices. Substantial equivalency for the ezlase™ has been determined through comparison to previously cleared devices." This implies that the device's performance for the new indications is considered to be on par with the cleared predicate devices, without providing specific quantifiable performance metrics for the ezlase™ itself for these new indications.
2. Sample size used for the test set and the data provenance
The document does not report any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) because it relies on a substantial equivalence comparison rather than new clinical trials demonstrating performance for the expanded indications. The existing predicate devices' clearance likely involved relevant data, but that data is not presented here as a "test set" for the ezlase™ in this 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or not provided in the document. As no new clinical study data with a specific 'test set' was presented for these expanded indications, there's no mention of experts establishing ground truth for such a set. The "ground truth" for substantial equivalence is based on the regulatory history and scientific understanding of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable or not provided in the document, as no specific test set requiring adjudication of outcomes is presented for the ezlase™ device for the expanded indications.
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
This information is not applicable. An MRMC study is relevant for diagnostic devices often involving human interpretation of images, especially when comparing AI assistance. The ezlase™ is a therapeutic laser device for teeth whitening, not a diagnostic imaging tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant in this context. There is no AI component mentioned in the device description.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The ezlase™ is a physical laser device operated by a human clinician, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" in this 510(k) is primarily centered on regulatory precedent and established safety/efficacy of predicate devices. The "truth" is that the predicate devices have been deemed safe and effective for these indications by the FDA. The submission argues that the ezlase™ is substantially equivalent to these devices, implying its performance will be similar. No new direct "ground truth" measurements (like specific outcomes data for a clinical trial) are presented for the ezlase™ for these expanded indications.
8. The sample size for the training set
This information is not applicable or not provided. Since the submission relies on substantial equivalence and does not describe a machine learning algorithm, there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable or not provided for the same reasons as #8.
§ 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.