(176 days)
The Diolase 980 D Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.
The Diolase 980 D Diode Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingival) using a contact fiber optic delivery system.
This document is a 510(k) Summary for the DioLase 980 D Diode Laser System and primarily focuses on establishing substantial equivalence to a predicate device rather than detailing studies with acceptance criteria for device performance in the way clinical diagnostic devices do.
Therefore, the requested information elements related to clinical studies, ground truth, expert adjudication, and effect size for AI models are not directly applicable or available in this type of submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a dental laser system), "acceptance criteria" and "reported device performance" are primarily based on technical specifications and intended use matching or being substantially equivalent to a legally marketed predicate device.
| Specifications | Acceptance Criteria (Predicate: BioLitec Smilepro 980) | Reported Device Performance (ADT Diolase 980 D) | Meets Criteria? |
|---|---|---|---|
| Intended Use | Same as predicate | Same as predicate | Yes |
| Wavelength | 980 nm | 980 nm | Yes |
| Output Power | 15W | 15W | Yes |
| Power Range | 1-15W | .2-15W | Yes |
| Increments | 1W | .2W - 1W | Yes |
| Operating Modes | Pulsed or Continuous | Pulsed or Continuous | Yes |
| Pulse Duration ON | .01 to 99.9 Sec. | .01 to 99.9 Sec. | Yes |
| Pulse Duration OFF | .01 to 99.9 Sec. | .01 to 99.9 Sec. | Yes |
| Aiming Beam | 635 nm; 4mW; Red | 635 nm; 4mW; Red | Yes |
| Cooling | Air Cooled | Air Cooled | Yes |
| Weight | 15 lbs. (9 kg) | 11 lbs. (5 kg) | (Better) |
| Dimensions | 14" x 9" x 7" | 14" x 9" x 3" | (Better) |
| Power Requirements | 110/220 V | 110/220 V | Yes |
The "study that proves the device meets the acceptance criteria" in this context is the 510(k) Premarket Notification process, which demonstrates substantial equivalence to a predicate device. The comparison table above is the core of that "study." The FDA review concludes that the device "is substantially equivalent... to legally marketed predicate devices."
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a "test set" in the context of clinical data or AI model evaluation. The "test" here involves comparing the technical specifications and intended uses of the new device against a predicate device. No patient data or clinical study data is detailed for this comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No "ground truth" based on expert consensus for a test set is described. The "ground truth" for substantial equivalence is the existing regulatory approval and performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. There is no test set or adjudication process described for clinical or AI performance. The regulatory review process itself involves expert review by the FDA.
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 is a medical device (laser system) and not an AI/imaging algorithm that would typically involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate device (BioLitec Smilepro 980 nm Diode Laser) and the demonstration that the DioLase 980 D Diode Laser System, through its technical specifications and intended use, is sufficiently similar to the predicate device to warrant regulatory approval without new clinical trials.
8. The Sample Size for the Training Set
Not applicable. This document pertains to a physical medical device and its substantial equivalence to a predicate, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See #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.