(37 days)
Intended for light activation of bleaching materials for teeth whitening. Note: This is an additional indication to the already cleared indications for use.
The Ceralas D Laser System that is the subject of this 510(k) notice is identical to the Ceralas D Laser System, which has already been cleared by FDA. The cleared Ceralas D Laser System is a complete self-contained compact surgical laser that utilizes gallium aluminum arsenide (GaALAs) semiconductor diodes to generate near-infrared laser radiation. The laser employs a modular design comprised of: (1) a laser diode: (2) a cooling module containing the laser diode, thermoelectric coolers, heat sink fins and fans; (3) an optics module containing a beamsplitter for control of optical power; (4) front control and display panel; and (5) RFIshielded, transformer power supply and control electronics. Interchangeable fiber optic delivery systems are coupled to the laser via an SMA 905 connector to deliver laser radiation to the target tissues. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module. The wavelength for the Ceralas D Laser System is 980 ± 30nm, and its laser aiming beam wavelength is 635mm+10mm. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end. The optical fiber is composed of quartz fiber core with a coaxially mounted protective sheath.
The provided text describes a 510(k) submission for the Ceralas Diode Laser System, seeking to add an indication for light activation of bleaching materials for tooth whitening. The submission focuses on demonstrating substantial equivalence to a predicate device for this specific intended use.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance for light activation of bleaching materials for teeth whitening (implicitly, similar effectiveness to predicate device). | Bench studies demonstrated that the Ceralas D 980nm Laser System performed similarly to the PAC light for light activation of bleaching materials for teeth whitening. Substantial equivalence was claimed based on this similar effect. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for the "bench studies."
- Data Provenance: The document does not specify the country of origin. It indicates the studies were "bench studies," which are laboratory-based, not clinical, and thus do not typically involve human subjects or retrospective/prospective data collection in the clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. Bench studies typically rely on physical measurements and established protocols rather than expert consensus on images or clinical outcomes.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided. Bench studies for physical devices primarily involve direct measurement and quantification of performance characteristics against a standard or predicate, not adjudication of interpretations as seen in diagnostic imaging.
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 and not provided. This device is a laser system for tooth whitening, not an AI-powered diagnostic tool requiring human reader interpretation or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not directly applicable in the context of an AI algorithm. However, the "bench studies" assess the laser system's direct performance (its ability to activate bleaching materials) in a standalone manner, without human intervention in the mechanism of activation. The system itself is the "standalone" entity being evaluated for its physical function.
7. The Type of Ground Truth Used
- The ground truth for the bench studies would be based on physical measurements and established scientific principles related to the activation of bleaching materials. This would likely involve quantifiable metrics of bleaching effectiveness or energy transfer, compared against the predicate device's known performance. It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
- This information is not applicable and not provided. The Ceralas Diode Laser System is a physical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable and not provided for the same reason as point 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.