(128 days)
For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.
Examples:
Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Reduction of bacterial level (decontamination) and inflammation Soft tissue crown lengthening 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)
Treatment of aphthous ulcers Vestibuloplasty Biopsy incision and excision Lesion (tumor) removal
For light activation for bleaching materials for teeth whitening For laser-assisted bleaching/whitening for teeth.
The laser source of the DioDent Micro 810/980 is a solid-state Gallium Aluminum Arsenide (GaAlAs) semiconductor diode. It produces invisible laser energy at the 810-nanometer or 980nm wavelength. The delivery system consists of an autoclavable flexible treatment fiber threaded through a lightweight, autoclavable hand piece. Activation occurs when the operator enables the laser and presses the footswitch. Releasing the footswitch suspends laser treatment. The footswitch can function as an on/off switch. A color touch-screen display panel allows the operator to adjust or set laser output level with minimal effort. The laser can operate in continuous wave or pulse mode.
The provided text is a 510(k) summary for the HOYA ConBio DioDent Micro 810/980 Dental Laser System. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this document.
Here's an analysis of the provided text in response to your questions:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or reported device performance based on a dedicated study designed to meet specific metrics. The 510(k) pathway relies on demonstrating substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
There is no mention of a test set sample size or data provenance because no clinical or non-clinical performance study against specific acceptance criteria was conducted or necessary for this 510(k) submission. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None".
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, as no test set or ground truth establishment process is described for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no test set requiring adjudication is described.
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 dental laser, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental laser, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no ground truth for performance evaluation was established in the context of this 510(k) summary. The submission relies on the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable, as this device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
Summary of Device Rationale from the Provided Text:
The basis for market clearance for the DioDent Micro 810/980 Dental Laser System is the demonstration of substantial equivalence to legally marketed predicate devices:
- SIROLaser by Sirona Dental Systems (K053161)
- DioDent II Dental Laser System by HOYA ConBio (K050274)
- Twilight Diode Laser System by BioLase Technologies (K991994)
The submission states that the DioDent Micro 810/980 is "equivalent in operating parameters, physical characteristics, and intended uses" to these predicate devices. The only noted difference among the equivalent devices is that the DioDent II (one of the predicates) is explicitly cleared for teeth whitening. The DioDent Micro 810/980's intended use also includes teeth whitening, implying it also aligns with the specified predicate for that particular indication.
Therefore, the "acceptance criteria" in this context are primarily regulatory – meeting the criteria for substantial equivalence under 21 CFR 878.4810 for a Class II medical device, which does not require new clinical performance studies if equivalence to a predicate device is adequately demonstrated.
§ 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.