(140 days)
The Dio-Dent 10 Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening. The Indications for Use of the Dio-Dent 10 Dental Diode Laser System include: Cosmetic Dentistry - Light activation for bleaching materials for teeth whitening, Laser-assisted bleaching/whitening of the teeth; Endodontology - Pulpotomy, Pulpotomy as an adjunct to root canal therapv; Periodontology - Sulcular debridement (removal of diseased or inflamed soft tissue in the periodental pocket); Oral Soft Tissue Surgery - Biopsy, Operculectomy, Gingivectomy, Gingivoplasty, Oral papillectomy, Leukoplakia, Treatment of aphthous ulcers, Fibroma removal, Frenectomy, Frenotomy, Tissue retraction for impressions. Incising and draining of abscesses, Draining fistulas, Exposure of unerupted partially erupted teeth, Lesion (tumor) removal, Implant recovery, Implant uncovering, Gingival troughing, Crown lengthening, Hemostasis of donor site, Coagulation and decontamination of extraction sites, Removal of granulation tissue, Degranulation of infrabony defects, Laser assisted flap surgery, Vestibuloplasty, Removal of hyperplastic tissues, Debridement of diseased epithelial lining
The Dio-Dent 10 Dental Diode Laser is designed to perform several medical procedures in the oral soft tissue and to perform laser assisted aesthetic tooth whitening procedures. A Gallium Aluminum Arsenide (GaAlAs) solid state laser diode provides optical energy to oral soft tissues. A fiber optic held by a handpiece delivers up to 10Watts laser energy. A visible light emitted from the handpiece's distal end targets the area of treatment. The optical power output and pulse may be adjusted to specific use requirements.
The provided text describes a 510(k) premarket notification for the Dio-Dent 10 Dental Diode Laser System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as typically found for novel devices or software.
Therefore, many of the requested categories for a rigorous study proving device performance against acceptance criteria cannot be answered directly from this type of regulatory submission. The information provided primarily pertains to compliance with safety standards and equivalence to existing devices.
Here's an analysis based on the provided text, highlighting what is (and isn't) present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table of acceptance criteria with numerical targets for performance and corresponding results from a dedicated study. Instead, it asserts compliance with general safety and performance standards, and substantial equivalence to predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety Standards | Complies with: |
| U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for class IV Laser Products. | Complies |
| European Medical Directive 93/42/EEC (Annex II) | Complies |
| IEC 60601-1 | Complies |
| IEC 60601-1-2 | Complies |
| IEC-60825-1 | Complies |
| IEC 601-2-22 | Complies |
| Technical Characteristics | Similar to cleared Ceralas™ and Opus 10™ predicate devices. |
| Laser Output Values | Well within previously cleared values of predicate dental diode laser systems. |
| Intended Use/Indications for Use | Previously cleared by FDA for predicate devices. |
| Safety and Effectiveness | Predicate devices and other previously cleared lasers with similar energy output have proven safety and effectiveness in the claimed indications. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical test set with a specific sample size. The "study" here is a demonstration of equivalence, relying on the established safety and effectiveness of predicate devices and compliance with recognized standards. There is no mention of a particular cohort of patients or data collected for this specific device's performance validation in a clinical setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The submission is not based on a study with a ground truth established by experts for performance evaluation. It relies on regulatory compliance and equivalence to predicate devices which have already undergone such assessments.
4. Adjudication Method for the Test Set:
Not applicable, as no specific test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. The device is a laser system, not an AI or imaging diagnostic tool that would typically undergo such a study.
6. Standalone (Algorithm Only) Performance:
Not applicable. The device is a physical laser system, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this submission is primarily:
- Compliance with international and national performance standards (e.g., 21 CFR 1040.10, 21 CFR 1040.11, IEC standards).
- Established safety and effectiveness of the predicate devices.
- Technical characteristics and output values that fall within the range of already cleared devices.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that involves a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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.