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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.

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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.

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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.

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