(239 days)
Waterlase Laser System Family is intended for use in oral hard and soft tissue dental applications. The Indications for Use are as follows:
Waterlase laser removal of porcelain and ceramic crowns and veneers
General Hard Tissue Indications (for use on adult and pediatric patients)
- 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 ●
Root Canal Hard Tissue Indications
- Tooth preparation to obtain access to root canal
- Root canal preparation including enlargement ●
- Root canal debridement and cleaning ●
Root Canal Disinfection
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Laser root canal disinfection after endodontic treatment
Endodontic Surgery (Root Amputation) Indications -
Flap preparation incision of soft tissue to prepare a flap and expose the bone ●
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. Cutting bone to prepare a window access to the apex (apices) of the root(s)
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Apicoectomy - amputation of the root end
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Root end preparation for retrofill amalgam or composite ●
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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
Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patient) 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
- Gingivoplastv .
- 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
- Soft tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- Vestibuloplasty
- 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.
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 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
- Removal of subgingival calculi in periodontal pockets with periodontitis by closed ● or open curettage
- Waterlase Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.
Waterlase Laser System Family utilizes an Er, Cr:YSGG (2780mm) solid-state laser and water atomization technology to safely and effectively cut, shave, contour, roughen, etch and resect oral hard-tissue and direct laser energy to perform oral soft tissue removal, incision, excision, ablation and coagulation. It is also used for specific endodontic and periodontal applications.
A single laser console houses the laser head, power supply, cooling system, micro-processor. The laser is controlled through a display which serves as the User Interface. A flexible fiber optic cable, connected to the laser, delivers laser energy to the treatment site through a laser tip attached to a handpiece. A visible light emitted from the handpiece head illuminates the area. A fine water spray is also emitted from the handpiece head to cool and hydrate the issue. A variety of laser tips are available for different clinical applications. The laser is activated by a footswitch.
The provided text describes a 510(k) submission for the "Waterlase Laser System Family" to the FDA. The submission focuses on establishing substantial equivalence to predicate devices and expanding indications for use, particularly for the removal of porcelain and ceramic crowns and veneers.
Here's an analysis of the acceptance criteria and study that proves the device meets the criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various performance evaluations and their successful outcomes as part of demonstrating substantial equivalence and supporting the expanded indications for use.
| Acceptance Criteria Category (Derived) | Reported Device Performance |
|---|---|
| Biocompatibility | The device's patient-contacting components demonstrated biocompatibility in accordance with ISO 10993-1. Testing included cytotoxicity, sensitization, intracutaneous reactivity, and systemic toxicity. |
| Electrical Safety & EMC | The device complies with current revisions of recognized standards, including IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 80601-2-60, and IEC 60601-1-2. |
| Software Verification & Validation | The software performs according to specifications and functions as intended. Documentation was provided per FDA guidance. The software design complies with IEC 62304. |
| Thermal Safety (Expanded Indication) | Bench testing demonstrated that laser irradiation at maximum power does not increase pulpal temperature to an unsafe level during the removal of various ceramic materials from natural teeth. This indicates thermal safety for the expanded indications. |
| Effectiveness (Expanded Indication) | Bench testing demonstrated the effectiveness of the device at the lowest settings for the removal of various ceramic materials from natural teeth. Clinical data from published and unpublished literature, further supported by bench testing, demonstrates its ability to quickly and safely remove porcelain and ceramic restorations without damaging underlying tooth structure or overheating surrounding tissue. |
| Substantial Equivalence | The Waterlase Laser System Family has the same intended use, technology, and design characteristics (energy source, wavelength, laser medium, beam delivery, controls, operating principle, mechanism of action) as the predicate devices (Waterlase Express K161669 and Waterlase MD Turbo Plus K101658). This overall comparison forms a key acceptance criterion for 510(k) clearance. Clinical and non-clinical data support the safety and efficacy of the device for the additional indication for Waterlase laser removal of porcelain and ceramic crowns and veneers, thus meeting the criteria for expanded indications. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "bench testing" for thermal effects and effectiveness related to the expanded indications (removal of porcelain and ceramic crowns/veneers). It states:
- "Performance bench testing has been completed to determine safety and efficacy when using a laser to remove various ceramic materials from natural teeth."
- "Thermal effects of the laser irradiation on the dentin surfaces and pulpal tissue have been evaluated."
However, the specific sample size (number of teeth/materials tested) for these bench tests is not provided in the document.
Regarding data provenance:
- The bench testing was likely prospective as it was conducted specifically for this submission.
- The origin of the materials (ceramic materials, natural teeth) for bench testing is not specified (e.g., in-vitro, ex-vivo, specific geographic origin).
- The document also references "Clinical data from published and unpublished scientific literature," which could be from various countries and be retrospective or prospective depending on the individual studies cited.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not specify the number of experts or their qualifications involved in establishing the "ground truth" for the bench testing. The evaluation of thermal effects and effectiveness would typically involve scientific measurement and analysis rather than expert consensus on subjective interpretations.
For the "clinical data from published and unpublished scientific literature," experts (e.g., dentists, researchers) would have conducted those studies, but their specific involvement in "establishing ground truth for this test set" (referring to the bench tests for this specific submission) is not detailed.
4. Adjudication Method for the Test Set:
Given that the primary evidence for the expanded indication relies on bench testing, there was likely no adjudication method (like 2+1 or 3+1 consensus) in the traditional sense, as this is typically applied to human interpretation of medical images or clinical outcomes. The "ground truth" for thermal safety and material efficacy in bench tests would be based on objective physical measurements and established scientific principles.
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. The Waterlase Laser System is a physical laser device, not an AI-assisted diagnostic or imaging tool involving "human readers" or "AI assistance" in the context of interpretation. Therefore, an MRMC study comparing human performance with and without AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. As the Waterlase Laser System is a surgical instrument, the concept of "standalone algorithm performance" without human-in-the-loop is not relevant. The device requires a trained human operator (dentist) for its use. The "bench testing" can be considered a form of standalone device performance evaluation in a controlled environment, demonstrating its physical capabilities.
7. The Type of Ground Truth Used:
For the bench testing, the ground truth was based on:
- Objective Measurements: Such as temperature readings (for pulpal temperature increase) and observational/analytical assessment of the material removal process and its impact on surrounding tooth structure (for efficacy).
- Established Scientific Principles: Adherence to safe temperature thresholds for pulpal health and effective material removal without damage.
For the support from "clinical data from published and unpublished scientific literature," the ground truth would have been derived from clinical outcomes (e.g., successful restoration removal, lack of post-operative complications, histological analysis if biopsies were included).
8. The Sample Size for the Training Set:
The document mentions "bench testing" and "clinical data from published and unpublished scientific literature" as supporting evidence. These are test/validation sets rather than "training sets" in the context of machine learning.
No training set is explicitly mentioned because the device is a physical laser system, not an AI/machine learning algorithm that requires a training set. The development of the device itself would have involved engineering design, prototyping, and internal testing, which might conceptually be seen as an iterative "training" process for the device design, but not in the data-driven sense of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" in the context of AI/machine learning for this physical device, this question is not applicable.
§ 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.