Search Results

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

• 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, 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

• 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 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: 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.

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.

Ask a specific question about this device

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

• 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, 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.

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Waterlase iPlus S is intended for use as a laser surgical instrument in the following medical specialties requiring the incision, excision, vaporization, ablation and coagulation of soft tissue: Dermatology/Plastic Surgery, Ear, Nose and Throat (ENT), Gastroenterology, General Surgery, Genitourinary/Urology, Gynecology, Ophthalmology, Oral/Maxillofacial Surgery, Podiatry, Pulmonary Surgery and Thoracic Surgery. It is indicated for the following expanded Indications for Use:

Dermatology/Plastic Surgery:
The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking of benign tumors, decubitis ulcers, cysts, diagnostic biopsy and skin resurfacing and treatment of wrinkles.

Ear, Nose and Throat (ENT):
The following indications can be used with the Angled or Straight Handpieces:
ENT surgery in soft, mucosal, cartilaginous and bony tissue, including endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectomy) dacryocystorhinostomy (DCR), ethmoidectomy, polypectomy, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangiectasias, septoplasty, lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia.

Gastroenterology:
The following indications can be used with the Angled or Straight Handpieces:
Gastroenterologic surgery of soft tissue, including cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias and telangiectasias of the Osler-Weber-Rendu disease.

General Surgery:
The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.

Genitourinary/Urology:
The following indications are used with the Angled Handpieces:
Genitourinary surgery of soft tissue, including treatment of bladder, urethral and ureteral tumors, superficial urinary bladder tumors, invasive bladder carcinomas, urethral and penile hemangioma, urethral strictures, lesions of the external genitalia, urethra and anus, penis, scrotum, (includes condyloma acuminate, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon, bladder neck obstructions.
The following indications are used with the Straight Handpieces:
Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy.

Gynecology:
The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.

Ophthalmology:
The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: General ophthalmic soft tissue surgical indications such as: Incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit.

Oral/Maxillofacial Surgery:
The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Oral/dental procedures for incision, excision, ablation, vaporization and hemostasis of soft tissue during gingivoplasties, gingivectomies, frenectomies, benign and malignant lesion removal, biopsies, leukoplakia and fibrotomy.

Podiatry:
The following indications can be used with the Angled or Contra-Angled Handpieces: Warts, plantar verrucae, large mosaic verrucae and matrixectomy.

Pulmonary Surgery:
The following indications can be used with the Angled or Straight Handpieces: Open and endoscopic pulmonary surgery.

Thoracic Surgery:
The following indications can be used with the Angled or Straight Handpieces: Surgical incision/excision, vaporization and coagulation of soft tissue during any thoracic surgery.

The Waterlase iPlus S system is an erbium, chromium, yttrium, scandium, garnet (ER,CR:YSGG) solid state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2.78 µm (2780 nm). The laser consists of a cabinet which houses the power supply, the cooling system, micro-controller, laser, foot switch, and fiber optic for delivery of laser energy with the fiber optic handpiece. Various handpiece and tip types are available depending upon the clinician's preference for the different applications. The Waterlase iPlus S system utilizes direct laser energy either with or without water for cooling and hydration to perform soft tissue incision, resection, ablation, vaporization, coagulation and hemostasis.

The provided document is a 510(k) premarket notification for the "Waterlase iPlus S" laser surgical instrument. It details the device's intended use and provides a comparison to predicate devices, but it does not contain acceptance criteria or a study proving device performance in the way typically associated with clinical or standalone performance studies for AI/CAD devices.

The document states:

• "No other performance testing was conducted since the purpose of this 510(k) is to only expand the Indications for Use from the previous 510(k) clearances under 510(k) Nos.: K101658 and K122368."
• "Clinical testing was not conducted on this device."
• The conclusion of substantial equivalence is based on "comparison of the Waterlase iPlus S with the same device, Waterlase iPlus, Profile Multi-Platform System and Laserscope VELA previously cleared by the FDA".

Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence based on expanded indications for use and technical similarity to previously cleared predicate devices, rather than new performance data.

Ask a specific question about this device

The Orthopedic iPlus Soft Tissue Loser is intended for use as a laser surgical instrument in orthopedic and podiatric surgery. It is indicated for the following Indications for Use, including the previously cleared dental indications, for completeness:

DENTAL INDICATIONS FOR USE

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

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*
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 patient

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 bacterial perpetration 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 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 MD Er,Cr:YSSG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)

ORTHOPEDIC INDICATIONS FOR USE
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an arthroscope, in contact and non-contact with tissue, in orthopedic and podiatric surgery, including:

• Soft and cartilaginous tissue in small and large joints (e.g., knee meniscectomy, debridement of inflamed synovial tissue)

The Orthopedic iPlus Soft Tissue Laser is an erbium, yttrium, scandium, gallium garnet (Er, Cr:YSGG) solid state laser that provides optical energy to the user controlled distribution of atomized water droplets at 2.78 μm (2780 nm). The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and fiber optic for delivery of laser energy with fiber optic handpiece setup. The Orthopedic iPlus Soft Tissue Loser utilizes direct laser energy either with or without water for cooling and hydration to perform soft tissue incision, resection, ablation, vaporization, coagulation and hemostasis.

The provided text is a 510(k) summary for the Orthopedic iPlus Soft Tissue Laser. It details the device's description, indications for use, and a claim of substantial equivalence to predicate devices, but it does not include acceptance criteria or the results of a study designed to prove the device meets specific performance criteria.

510(k) submissions typically demonstrate substantial equivalence to legally marketed predicate devices, rather than conducting new performance studies with specific acceptance criteria as might be seen with a PMA or a more rigorous de novo submission. The document explicitly states:

"Comparison of this device with the previously cleared devices provided in this 510(k) submission demonstrates the safety and effectiveness of this device for the above indications, and supports substantial equivalence to the legally-marketed predicate devices."

Therefore, based on the provided text, I cannot complete the requested tables and information. The document focuses on demonstrating similarity to existing devices and expanding indications, not on presenting novel performance data against defined acceptance criteria.

To answer your request, here's what the document does provide in relation to what you asked for, and what it does not provide:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be provided. The document does not define specific acceptance criteria (e.g., accuracy, sensitivity, specificity, or surgical outcome metrics) for the Orthopedic iPlus Soft Tissue Laser. Instead, it relies on substantial equivalence to predicate devices. There are no reported performance metrics for the device against such criteria.

All other points (2-9) are not applicable or cannot be answered based on the provided 510(k) summary. This type of submission relies on the established safety and effectiveness of predicate devices. It typically does not involve new clinical studies for performance metrics or ground truth establishment in the way a de novo or PMA submission might.

Summary of missing information and reasons:

• Sample size and data provenance (test set): Not applicable, as no new performance study with a test set is described.
• Number of experts and qualifications (ground truth): Not applicable, as no new ground truth establishment process for a performance study is described.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not conducted or reported in this document. The focus is on substantial equivalence.
• Standalone performance study: Not conducted or reported. Substantial equivalence relies on the predicate devices' established performance.
• Type of ground truth: Not applicable, as no new ground truth was established for a performance study.
• Sample size for training set: Not applicable, as this is not an AI/ML device and no training set is mentioned.
• How ground truth for training set was established: Not applicable.

Ask a specific question about this device

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

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*:
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
• 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 patient

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 MD Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)

The Waterlase MD Turbo Plus is a dental laser device indicated for incision, excision, removal, and specific dental therapies, such as root canal therapy and periodontal therapy. All indications for use submitted for the Waterlase® MD Turbo Plus have been previously cleared by the FDA and there are no new indications included for this device.

This K101658 510(k) submission for the Waterlase MD Turbo Plus does not contain specific acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria. Instead, it relies on substantial equivalence to previously cleared predicate devices.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or report device performance in a formal table with metrics like sensitivity, specificity, accuracy, etc. The "performance" described is largely qualitative and comparative to predicate devices.

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

• Test Set Sample Size: Not explicitly stated. For the higher energy per pulse, it mentions "comparison of class II cavity preparations prepared at 600 mJ per pulse." For the new frequencies, it mentions "Gingivoplasties performed at the two new frequencies on pig jaw gingiva." No specific numbers of preparations or gingivoplasties are provided.
• Data Provenance: The document does not specify the country of origin. The test for gingivoplasty was performed on "pig jaw gingiva," indicating an in vitro or ex vivo animal model rather than human clinical data. The comparison of Class II cavity preparations suggests an in vitro or ex vivo setting as well, given the lack of clinical study details. The data is likely retrospective in the sense that it's a comparison to established performance of predicate devices, or bench/laboratory for the specific tests mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not performed. The submission explicitly states: "No clinical performance data is required for this submission." The equivalency is established through comparison to predicate devices and limited performance data (Class II cavity preparations and gingivoplasties on pig jaw gingiva), not through human reader studies.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

The Waterlase MD Turbo Plus is a physical dental laser device, not an algorithm. Therefore, a "standalone algorithm performance" study is not applicable. The performance data mentioned (cavity preparations, gingivoplasties) represents the device's direct physical interaction with tissue.

7. Type of Ground Truth Used:

• For the Class II cavity preparations, the "ground truth" implicitly refers to the established effectiveness and safety of the predicate device (Waterlase® MD Turbo) for this application. The new device's performance is compared to this established benchmark.
• For the gingivoplasties on pig jaw gingiva, the "ground truth" would be the observed clinical effect (e.g., successful tissue removal, absence of adverse effects) as assessed by technical or dental experts, compared to the expected outcome from predicate devices for a similar indication. This is a technical assessment rather than a diagnostic "ground truth" like pathology or clinical outcomes in a human patient.

8. Sample Size for the Training Set:

This is irrelevant as the Waterlase MD Turbo Plus is a physical device and not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This is irrelevant as the Waterlase MD Turbo Plus is a physical device and not an AI/ML algorithm.

Ask a specific question about this device

Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage.

The Waterlase MD dental laser system is a device used to perform a variety of dental soft and hard tissue indications. For hard tissue procedures the Waterlase MD uses the Erbium,Chromium:Yttrium,Scandium,Gallium Garnet (Er,Cr.YSGG) laser in combination with advanced water atomization spray technology to cut, remove, shave, contour, roughen and etch tissues. Soft tissue procedures are performed using two different modes of operation. H and S. where direct Er.Cr. YSGG laser energy is applied to incise, excise or ablate these tissues. For soft tissue procedures the water spray is applied for hydration. cooling or to keep tissues and the field of view clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping tissues and field of view clean.

A flexible fiber optic terminated into the handpiece delivers the Waterlase®MD laser energy to the end fiber tip and target. A visible aiming light emitted from the handpiece's distal end pinpoints the area of treatment. Three fiber optic ports provide illumination from the handpiece to the tissue site in addition to the center beam emitting source. In both hard and soft tissue applications the power output, pulse duration, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. The spot size and spot geometry can also be varied by changing tips which include different diameters and end configurations.

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is primarily a regulatory filing for an expanded indication for use of the Waterlase MD dental laser system, establishing its substantial equivalency to previously cleared devices.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, study design, sample sizes, expert involvement, or ground truth.

The document discusses the device description, indications for use, contraindications, and regulatory information, but it does not include data from a clinical trial or performance study that would typically involve acceptance criteria. The basis for clearance is "Substantial Equivalence" to another device, meaning it's assumed to perform similarly to an already approved device without necessarily requiring new performance studies against specific acceptance criteria.

Ask a specific question about this device

Waterlase MD Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).

The Waterlase MD is a dental laser device previously cleared by the FDA (K031140) for hard and soft tissue dental indications, including periodontal procedures such as: 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, infected, 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, full thickness flap, partial thickness flap, and split thickness flap. The Waterlase MD is capable of soft tissue incision, excision, vaporization, ablation and coagulation. In the periodontal pocket, the Waterlase MD is an effective laser for removing diseased/inflamed tissue, and the diseased epithelium lining from underlying connective tissues. A flexible fiber optic terminated into the handpiece delivers the Waterlase MD laser energy to the end fiber tip and target. A visible aiming light emitted from the handpiece's distal end pinpoints the area of treatment. Three fiber optic ports provide illumination from the handpiece to the tissue site in addition to the center beam emitting source. In both hard and soft tissue applications the power output, pulse duration, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. The spot size and spot geometry can also be varied by changing tips which include different diameters and end configurations.

This document is a 510(k) Summary of Safety and Effectiveness for the Waterlase® MD dental laser, seeking expanded indications for use. It primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria.

Therefore, many of the requested sections (e.g., specific acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) cannot be fully populated as they are not explicitly detailed in this type of regulatory submission. The document confirms the device's substantial equivalence based on the same indication as previously cleared devices, implying that the established safety and effectiveness of those predicates extend to the Waterlase® MD for this expanded indication.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria and reported device performance for a study. The submission for a 510(k) is about demonstrating substantial equivalence to a predicate device, not necessarily showcasing new performance data against pre-defined acceptance criteria for a novel functionality. The key "performance" here is that the device can perform the expanded indication in a manner similar to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This 510(k) submission does not describe a new clinical study with a test set. It relies on the established safety and efficacy of predicate devices for the specified indication.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No new test set or ground truth establishment by experts is detailed in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new test set with adjudication is detailed.

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

Not applicable. This is not an AI device, and no MRMC study is mentioned.

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

Not applicable. This is a medical device (laser), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" implicitly used for this 510(k) submission is the established clinical effectiveness and safety of predicate devices for the indication of "cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium". This is based on historical clinical evidence and regulatory clearances for those predicates. No new ground truth data is generated for this submission.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is not a machine learning or AI device.

Summary of Device Acceptance and Study:

Acceptance Criteria & Reported Performance:

1. Have the same intended use as a legally marketed predicate device.
2. Have the same technological characteristics as the predicate device; OR
3. Have different technological characteristics than the predicate device BUT
   a. The new device does not raise different questions of safety and effectiveness; AND
   b. The new device is as safe and effective as the legally marketed predicate device. | The Waterlase® MD is substantially equivalent because:
4. Intended Use: The expanded indication ("Waterlase MD Er, Cr. YSG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)") is the same as an indication previously cleared by the FDA for other dental laser devices.
5. Technological Characteristics: The document describes the Waterlase MD's existing capabilities (soft tissue incision, excision, vaporization, ablation, coagulation, specified energy delivery, adjustable parameters) for periodontal procedures, which are presumably similar to the predicate devices for this specific indication. The core technology (Er,Cr:YSGG laser) and delivery mechanism are established. |

The "Study" Proving Acceptance:

The "study" in this context is the 510(k) substantial equivalence determination process itself, rather than a specific clinical trial conducted for this submission.

• Study Type: Substantial Equivalence Review based on comparison to predicate devices.
• Methodology: The sponsor (Biolase Technology, Inc.) submitted documentation demonstrating that the Waterlase® MD, when used for the expanded indication of "cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium," meets the criteria for substantial equivalence to existing, legally marketed dental laser devices with the same indication. This generally involves:
  • Identification of Predicate Devices: The document lists several equivalent devices: Millennium Dental Technologies, Inc. Periolase Fidelis III Laser System Family; Fotona d.d. Smart CO2; Cynosure, Inc.
  • Comparison of Indications for Use: The key point made directly in the "Conclusion" section is: "The indication included herein is the same as the indication that has been previously cleared by the FDA for other dental laser devices."
  • Comparison of Technological Characteristics: The document describes the Waterlase MD's existing features relevant to performing the procedure (e.g., soft tissue incision, excision, vaporization, ablation, coagulation, flexible fiber optic delivery, adjustable parameters like power output, pulse duration, repetition rate, air/water flow, spot size). The implication is that these characteristics are comparable to the predicate devices for achieving the intended clinical outcome.
  • Safety and Effectiveness Argument: By demonstrating identical intended use and comparable technological characteristics to cleared devices, the submission implicitly argues that the Waterlase® MD raises no new questions of safety or effectiveness for this expanded indication and is as safe and effective as its predicates.
• Outcome: The FDA reviewed the submission (K083927) and determined that the Waterlase® MD is "substantially equivalent" for the stated expanded indication, as evidenced by the FDA's clearance letter dated October 1, 2009.

Ask a specific question about this device

This device may be used for the following indications (previously cleared under submissions K030523, K071363, and K081589):

General Indications *

• r 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

• 이 Tooth preparation to obtain access to root canal
• Root canal preparation including enlargement 트
• l Root canal debridement and cleaning Root Canal Disinfection
• 트 Laser root canal disinfection after endodontic instrumentation Endodontic Surgery (Root Amputation) Indications
• Flap preparation incision of soft tissue to prepare a flap and expose the bone. 트
• Cutting bone to prepare a window access to the apex (apices) of the root(s). l
• Apicoectomy amputation of the root end. 트
• Root end preparation for retrofill amalgam or composite. 트
• Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic 트 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*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:

• 트 Excisional and incisional biopsies
• I Exposure of unerupted teeth
• I 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)
• I Frenectomy and frenotomy
• Gingival troughing for crown impressions I
• 미 Gingivectomy
• I Gingivoplasty
• I Gingival incision and excision
• 트 Hemostasis
• I Implant recovery
• .. Incision and drainage of abscesses
• Laser soft tissue curettage of the post-extraction tooth sockets and the periapical 프 area during apical surgery
• 트 Leukoplakia
• Operculectomy 바
• 트 Oral papillectomies
• l Operculectomy
• Oral papillectomies 트
• 트 Pulpotomy
• Pulp extirpation ■
• 트 Pulpotomy as an adjunct to root canal therapy
• Root canal debridement and cleaning 트
• 트 Reduction of gingival hypertrophy
• Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic 트 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 B
• 트 Vestibuloplasty
• • For use on adult and pediatric patient Laser Periodontal Procedures
• s Full thickness flap
• l Partial thickness flap
• 트 Split thickness flap
• 트 Laser soft tissue curettage
• 트 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 I 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 프 grafting, etc.)
• . Osseous crown lengthening

The Waterlase C100 dental laser system is a diverse device utilized to perform a variety of dental applications. For hard tissue procedures the Waterlase® C100 uses the Erbium, Chromium, Yttrium, Scandium, Gallium Gamet (Er,Cr.YSGG) laser in combination with advanced water atomization spray 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 tissues clean.

A flexible fiberoptic handpiece delivers the Waterlase® C100 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 (frequency) and air and water flow rates are adjustable to specific user requirements.

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them.

The document is a 510(k) Special Summary for the Waterlase C100, which focuses on demonstrating substantial equivalence to previously cleared predicate devices. It lists the device description, indications for use, and confirms that these indications are the same as those previously cleared. The FDA's letter also confirms substantial equivalence.

This type of submission typically does not include detailed study data, acceptance criteria, or performance metrics in the same way a de novo or PMA submission would. It relies on the prior clearance of the predicate devices for performance validation.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory clearance based on equivalence, not a scientific study report demonstrating novel performance against defined criteria.

Ask a specific question about this device

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. 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. Bone Surgical Indications: Cutting, shaving, contouring and resection of oral osseous tissues (bone); Osteotomy. 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; Soft tissue crown lengthening; Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa; Vestibuloplasty. 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.

The Waterlase MD is a dental laser device previously cleared by the FDA for hard and soft tissue dental indications (K031140, K071363). The only changes from the previously cleared device are the addition of the Turbo handpiece, which combines minor software and graphics changes that will be added to the Waterlase MD laser system. This software does not change the operational software, but adds a "Select" icon on the control panel, and unassigned pre-sets fields for use by the dentist to store preferred setting selections. There are no other hardware or software changes to the Waterlase MD device pending herein when compared to the device cleared under K031140 and K071363. Materials used for the Turbo handpiece are the same as those for the MD Gold handpiece. Biocompatibility testing of these materials was conducted in compliance with 21 CFR Part 820, Quality System Regulation, Subpart C, Sec. 820.30 - Design Controls, and ISO 13485-2003, Section 7.3 - Design and Development; documented results (on file) confirmed there is no biocompatibility risk presented by these materials.

This document describes a Special 510(k) submission for the KOGOLFI Waterlase® MD with a new Turbo Handpiece accessory submitted by Biolase Technology, Inc. The core of this submission is to demonstrate substantial equivalence to previously cleared devices (K031140, K071363) by showing that the new accessory does not introduce new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain specific acceptance criteria for performance metrics in the traditional sense of a study with quantitative results. Instead, the "acceptance criteria" for this Special 510(k) is the demonstration of substantial equivalence to predicate devices. This means that:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No separate "test set" or clinical study data (in terms of patient samples) is referenced for this Special 510(k). This type of submission relies on the existing safety and effectiveness data of the predicate devices. The changes applied (Turbo Handpiece, minor software/graphics) are considered "minor" enough not to necessitate new clinical testing on human subjects for performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. As no clinical test set was used for performance evaluation, there were no experts establishing ground truth in this context. The "ground truth" for this submission are the established safety and effectiveness profiles of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical test set was used.

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:

Not applicable. This device is a dental laser system, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.

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

Not applicable. This device is a physical laser system requiring human operation, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices (Waterlase® MD, K031140, K071363), which were cleared by the FDA based on their own submissions likely involving a combination of performance testing, bench testing, biocompatibility testing, electrical safety testing, and potentially clinical data or reliance on existing scientific literature for similar devices. For this Special 510(k), the "ground truth" is that the modifications do not alter these established profiles.

8. The sample size for the training set:

Not applicable. There is no AI model or "training set" mentioned or implied by the nature of this submission. The "software" changes are described as minor graphical and preset additions, not a learning algorithm.

9. How the ground truth for the training set was established:

Not applicable, as no training set was used.

Ask a specific question about this device