(451 days)
Waterlase iPlus with the fractional handpiece is indicated for use in dermatology for skin resurfacing.
Waterlase iPlus when used with the non-fractional handpieces is indicated for use in the following oral hard and soft tissue dental applications:
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:
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Excisional and incisional biopsies
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Exposure of unerupted teeth
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Fibroma removal
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Flap preparation incision of soft tissue to prepare a flap and expose the bone
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Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
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Frenectomy and frenotomy
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Gingival troughing for crown impressions
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Gingivectomy
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Gingivoplasty
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Gingival incision and excision
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Hemostasis
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Implant recovery
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Incision and drainage of abscesses
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Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
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Leukoplakia
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Operculectomy
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Oral papillectomies
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Pulpotomy
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Pulp extirpation
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Pulpotomy as an adjunct to root canal therapy
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Root canal debridement and cleaning
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Reduction of gingival hypertrophy
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Soft tissue crown lengthening
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Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
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Vestibuloplasty
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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.
Laser Periodontal Procedures
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Full thickness flap
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Partial thickness flap
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Split thickness flap
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Laser soft tissue curettage
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Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
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Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium
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Removal of granulation tissue from bony defects
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Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility)
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Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
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Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
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Osseous crown lengthening
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Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
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Waterlase Er.Cr: Y SGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.
Waterlase iPlus utilizes an Er, Cr YSGG (2780nm) solid-state laser and water atomization technology for hard and soft tissue incision, excision, ablation, vaporization and coagulation of soft and hard tissue.
The laser consists of a console the houses the laser head, power supply, cooling system, micro-processor and electronics, a footswitch which activates the laser, and a fiber optic cable for delivery of laser energy through a handpiece to the treatment site. A fine water spray is also emitted from the handpiece to cool and hydrate the issue. The laser is controlled through a touch screen display which serves as the User Interface.
This document describes the Waterlase iPlus Laser System with a Fractional Handpiece, indicated for dermatological skin resurfacing.
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format with specific performance metrics. Instead, it describes performance testing conducted to ensure safety and effectiveness in comparison to predicate devices. The "reported device performance" is qualitative and indicates successful completion of these tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility in accordance with ISO 10993-1 | Biocompatibility evaluation conducted; cytotoxicity testing completed on patient-contacting disposable accessory applicator. |
| Software performs according to specifications and functions as intended, conforming to IEC 62304. | Software verification and validation conducted; results demonstrate performance according to specifications and functions intended; conforms with IEC 62304. |
| Compliance with electrical safety and EMC standards (IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 80601-2-60, IEC 60601-1-2). | Electrical safety and EMC testing conducted; device complies with current revisions of recognized standards. |
| Bench performance of the Fractional Handpiece and trunk fiber designs verified for peak performance settings and accessory requirements. | Verification of Fractional Handpiece and trunk fiber designs completed; accessory passed all requirement criteria. |
| Animal tissue testing demonstrates micro-ablation depths and widths within the range of predicate fractional laser devices for skin resurfacing. | Ex-vivo and in-vivo animal tissue testing conducted; results support that the device produces fractional beam micro-ablation depths and widths within the range of other cleared fractional laser devices for dermatological skin resurfacing. |
2. Sample Size Used for the Test Set and Data Provenance:
- Biocompatibility Testing: Cytotoxicity testing was completed on "the only patient contacting disposable accessory applicator." This refers to the component itself, not a sample size of patients or data.
- Software Verification and Validation: No sample size of patients or data is provided. This typically involves testing the software against its functional and non-functional requirements.
- Electrical Safety and EMC: No sample size of patients or data is provided. This involves testing the physical device according to electrical and electromagnetic standards.
- Performance Testing - Bench: No specific numerical sample size is given for the bench tests. It states "A verification of the Fractional Handpiece and trunk fiber designs was completed" and "the accessory passed all requirement criteria."
- Performance Testing - Animal: No specific numerical sample size is given for ex-vivo and in-vivo animal tissue testing. It mentions "Ex-vivo and in-vivo animal tissue testing was conducted."
The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, beyond "ex-vivo and in-vivo animal tissue testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of human experts to establish ground truth in the context of the described performance studies (biocompatibility, software, electrical safety, bench testing, animal testing). The "ground truth" for these types of studies typically relies on objective measurements, established engineering principles, and animal tissue responses.
4. Adjudication Method for the Test Set:
Not applicable, as the tests described (biocompatibility, software, electrical safety, bench, animal) do not involve human interpretation or subjective assessments that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to predicate devices through technical and performance testing, not on comparing reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The Waterlase iPlus Laser System is a physical medical device, not an AI algorithm. Its performance is evaluated through direct physical and biological testing, not through standalone algorithm performance.
7. The Type of Ground Truth Used:
- Biocompatibility: Established standards (ISO 10993-1) for biological response.
- Software Verification and Validation: Software specifications and functional requirements as defined by the manufacturer and compliance with IEC 62304.
- Electrical Safety and EMC: Recognized electrical safety and electromagnetic compatibility standards (e.g., IEC 60601 series).
- Performance Testing - Bench: Technical specifications and engineering requirements for the device components.
- Performance Testing - Animal: Objective measurements of "depth and width of penetration" in animal tissue, compared to established ranges for predicate devices. This is a form of biophysical ground truth based on tissue response.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.