(931 days)
The KaVo KEY Laser Models 1243+ and 1242 are intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry. This includes the following: Surgery (oral and dental) on soft tissue Aphthae (herpes, decubitus) Incision for drainage of abscesses Frenectomy, incision on frenulum of the cheek Excision of fibromas and flap fibromas Gingivectorny in the case of hyperplasias of the gingiva or excision of hyperplasias Preprosthetic surgery, flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasias, epulides, papillomas, fibromatoses, benign growths Removal of diseased or inflamed tissue in the periodontal pocket (sulcular debridement) Tooth preparation to obtain access to the root canal Pulpotomy Pulp Extirpation Pulpotomy as an adjunct to root canal therapy Root canal debridement and cleaning. The KaVo KEY Laser Models 1243+ and 1242 are intended for ablation and vaporization of hard tissue in dentistry. The uses include: Removal of carious tissue Enamel Etching Cavity preparation Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curretage.
The KaVo KEY Laser 1243+ is an erbium laser which emits its energy at 2.94 microns. The laser consists of a cabinet, foot switch, fiber optic and hand pieces, and a software controlled user/laser interface.
The provided documentation describes the KaVo KEY Laser 1243+ and KaVo KEY Laser 1242, which are erbium lasers intended for various dental procedures, including the removal of subgingival calculus. The acceptance criteria and supporting study are specifically detailed for this indication.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for removal of subgingival calculus) | Reported Device Performance |
|---|---|
| Effectiveness: Produce equivalent or superior results in removing subgingival calculus compared to mechanical removal/planing. | Proven: "The results of a well-controlled clinical study with a 2-year follow-up provided evidence that the Er: YAG, i.e., the KaVo KEY Laser 1242, produced equivalent or superior results when compared to mechanical removal/planing of subgingival calculus from the roots of teeth." "The clinical data demonstrated that the KaVo KEY II laser performed as designed in the clinical study and that the clinical results achieved were equivalent or better than those achieved in the control (mechanical removal of subgingival calculi) group." |
| Safety - Surface Damage: Root surfaces are not unduly damaged by laser energy. | Proven: "SEM examination of surfaces provided assurance that the root surfaces were not unduly damaged by the laser energy." |
| Safety - Cell Adhesion: Fibroblasts would/could adhere to the laser-treated surface in numbers and types comparable or superior to surfaces scaled or planed by other methods. | Proven: "Laboratory tests demonstrated that fibroblasts would/could adhere to the laser-treated surface in numbers and types comparable or superior to surfaces scaled or planed by other methods." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size for the clinical study. It refers to it as a "well-controlled clinical study."
- Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The study was a "well-controlled clinical investigation" with a "2-year follow-up." It can be inferred to be prospective due to the follow-up period and objective criteria measurement at specific intervals.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The study measured "objective criteria" at various time points, suggesting quantitative evaluation rather than subjective expert consensus for the primary outcome.
4. Adjudication Method for the Test Set
- Not specified. The mention of "objective criteria were measured and recorded" suggests quantitative measurement rather than an adjudication process typically used for subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. This study is for a medical laser device, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in a sense. The device (KaVo KEY Laser 1242) itself performs the treatment (removal of subgingival calculus), and its performance was evaluated against a control group (mechanical removal). While a clinician operates the device, the study assesses the device's effectiveness in achieving the therapeutic outcome.
7. The Type of Ground Truth Used
- The ground truth for the clinical study was established through objective criteria measured over a 2-year follow-up period. These criteria were used to compare the laser's performance to mechanical removal for subgingival calculus.
- Additionally, SEM examination provided ground truth for surface damage, and laboratory cell adhesion tests provided ground truth for biocompatibility.
8. The Sample Size for the Training Set
- Not applicable/Not specified. This is a medical device study, not an AI model requiring a distinct "training set." The in vitro, in vivo, and clinical studies serve to validate the device's performance.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See 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.