(454 days)
Hard Tissue
General Indications*
- Class I, II, III, IV and V cavity preparation
- Caries removal
- Hard tissue surface roughening or etching
- Enameloplasty, excavation of pits and fissures for placement of sealants .
- For use on adult and pediatric patients
Root Canal Hard Tissue Indications
- Tooth preparation to obtain access to root canal
- Root canal preparation including enlargement .
- Root canal debridement and cleaning
Endodontic Surgery (Root Amputation) Indications
- Flap preparation incision of soft tissue to prepare a flap and expose the bone, .
- Cutting bone to prepare a window access to the apex (apices) of the root(s).
- Apicoectomy amputation of the root end. .
- Root end preparation for retrofill amalgam or composite.
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
Bone Surgical Indications
- Cutting, shaving, contouring and resection of oral osseous tissues (bone) .
- Osteotomy
Laser Periodontal Procedures
- Full thickness flap
- Partial thickness flap
- Split thickness flap
- Laser soft tissue curettage
- Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
- Removal of granulation tissue from bony defects
- Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
- Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours )
- Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
- Osseous crown lengthening
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
- Excisional and incisional biopsies
- Exposure of unerupted teeth
- Fibroma removal
- Flap preparation incision of soft tissue to prepare a flap and expose the bone. .
- Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
- Frenectomy and frenotomy .
- Gingival troughing for crown impressions
- Gingivectomy ●
- Gingivoplasty
- Gingival incision and excision
- Hemostasis
- Implant recovery
- Incision and drainage of abscesses
- Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
- Leukoplakia
- Operculectomy
- Oral papillectomies
- Pulpotomy ◆
- Pulp extirpation
- Pulpotomy as an adjunct to root canal therapy
- Root canal debridement and cleaning
- Reduction of gingival hypertrophy
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. - Soft tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- Vestibuloplasty
- For use on adult and pediatric patients
The Waterlase hydrokinetic dental laser system is a diverse device utilized to perform a variety of dental applications. For hard tissue procedures the Waterlase uses the Erbium, Chromium: Yttrium, Scandium, Gallium Gamet (Er,Cr. YSGG) laser in combination with advanced water atomization technology to cut, remove, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er.Cr.YSGG laser energy is applied to incise, excise or ablate these tissues. In soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping the tissues clean.
A flexible fiberoptic handpiece delivers the Waterlase laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. In both hard and soft tissue applications the power output, pulse energy, repetition rate and air and water flow rates are adjustable to specific user requirements.
This 510(k) premarket notification for the Waterlase® Er,Cr:YSGG laser and Hydrokinetic System provides information on its indications for use and states its substantial equivalence to previously cleared devices. However, it does not contain the specific details required to answer your request about acceptance criteria and a study demonstrating the device meets those criteria.
Here's why and what information is missing:
- Acceptance Criteria and Device Performance: The document does not explicitly list any acceptance criteria (e.g., performance metrics, thresholds, or clinical endpoints) that a study would be designed to meet. Consequently, it also does not report the device's performance against such criteria.
- Study Details: There is no mention of an actual study conducted to prove the device meets any specific criteria. The document relies on the concept of "substantial equivalence" to previously cleared devices. This means that instead of conducting new clinical trials or performance studies against defined criteria for this specific submission, the manufacturer asserts that the Waterlase® device is as safe and effective as other legally marketed predicate devices.
Therefore, for your specific questions, the answers are largely "not applicable" or "not provided in the given document."
Here's a breakdown of the requested information based on the provided text, highlighting the missing elements:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., specific clinical outcomes, precision, accuracy) | Reported Device Performance |
|---|---|
| Not specified in the document. | Not reported in the document. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not applicable, as no specific performance study or test set is described.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable, as no specific study data is presented.
3. Number of Experts and Their Qualifications for Ground Truth
- Not applicable, as no study involving expert-established ground truth for a test set is described.
4. Adjudication Method for the Test Set
- Not applicable, as no test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as this device is a laser system, not an AI-assisted diagnostic tool, and no MRMC study was conducted.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a physical laser system, not an algorithm, and no standalone performance study is described.
7. Type of Ground Truth Used
- Not applicable, as no specific study utilizing ground truth is described. The approval is based on substantial equivalence.
8. Sample Size for the Training Set
- Not applicable, as this is a medical device (laser system) and not an AI/machine learning algorithm requiring a training set.
9. How Ground Truth for the Training Set Was Established
- Not applicable, as this is a medical device (laser system) and not an AI/machine learning algorithm requiring a training set with established ground truth.
Summary of the Document's Approach:
The provided 510(k) summary (K031140) for the Waterlase® device demonstrates its "substantial equivalence" to existing, legally marketed devices. This regulatory pathway typically involves comparing the new device's technological characteristics and intended uses to a predicate device, rather than requiring new, full-scale clinical trials or explicit performance studies against specific acceptance criteria. The document lists the device description and an extensive range of indications for use, but it does not detail any studies designed to prove performance against quantitative metrics.
§ 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.