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The Waterlase Express indications for use are as follows:

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

• · 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
• · 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

Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patient) Incision, 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
• · 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 Express is an erbium, chromium: yttrium, scandium, gallium garnet (Er,Cr.YSGG) solid-state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2780 nm. The laser system consists of a top-table console which houses the laser head, power supply, cooling system, micro-processor and a removable tablet PC as a control panel. A flexible fiber cable, connected to the laser console, 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. The laser is activated by means of a wireless footswitch. Various laser tips are available for different clinical applications. Waterlase Express utilizes advanced laser and water atomization technologies to cut. shave, contour, roughen, etch and resect oral hard tissues, and direct laser energy, with or without water for cooling and hydration, to perform oral soft tissue removal, incision, excision, ablation and coagulation as well as specific endodontic and periodontal applications.

Note: The provided document is a 510(k) summary for a medical device (Waterlase Express). This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and studies in the same way one might for a novel AI/ML diagnostic. Therefore, some of the requested information (e.g., sample sizes for training sets, number of experts for ground truth in AI/ML studies, MRMC studies) is not applicable or not present in this regulatory document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable form often seen in AI/ML device submissions. Instead, the substantial equivalence is demonstrated by showing that the new device (Waterlase Express) performs "as well as" or "equivalent to" the predicate device (Waterlase MD Turbo Plus) based on various performance data. For a direct comparison, the table below will summarize the technological characteristics and the performance statements made.

2. Sample Size Used for the Test Set and the Data Provenance

• Test Set Sample Size:
  • For biocompatibility testing, electrical safety, EMC, and software V&V, the "sample size" refers to the device units tested or the software code, not patient data. The document does not specify the number of devices or software modules tested.
  • For bench testing, the document states "In-vitro testing was conducted on soft and hard tissue." No specific number of tissue samples (i.e., test set sample size) is provided.
  • Clinical testing was not performed for this device as the indications for use are the same as the predicate and performance characteristics are deemed equivalent based on bench testing. Thus, there is no human "test set" in the context of clinical performance.
• Data Provenance: Not applicable for a device that relies on bench testing and substantial equivalence. The "data" comes from laboratory and engineering tests of the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• This is not applicable. Since no clinical testing or AI/ML components requiring human expert ground truth for classification/diagnosis are detailed, no experts were used in this manner. The "ground truth" for the device's functionality and safety is established by adherence to recognized standards and comparative bench testing against a well-established predicate.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• This is not applicable. There was no clinical study with human readers/interpreters that would require an adjudication method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This is not applicable. The Waterlase Express is a surgical laser device, not an AI/ML diagnostic or assistive tool that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• This is not applicable. The Waterlase Express is a medical device, not an algorithm, and it is used by a human operator (dentist/surgeon).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the technical and performance aspects:
  • Biocompatibility: Ground truth is established by adherence to ISO 10993-1.
  • Electrical Safety & EMC: Ground truth is established by adherence to recognized IEC standards.
  • Software V&V: Ground truth is established by the device's specifications and FDA guidance.
  • Bench Testing: The "ground truth" for performance is the demonstrated performance of the predicate device (Waterlase MD Turbo Plus) when tested under comparable in-vitro conditions. The studies aim to show the subject device performs effectively in the same way the predicate device does on hard and soft tissues.

8. The Sample Size for the Training Set

• This is not applicable. This device is not an AI/ML system, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

• This is not applicable. As there is no AI/ML component or "training set," no ground truth was established for this purpose.

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