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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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Root Canal Hard Tissue Indications (for use on adult and pediatric patients)

• Root canal preparation including enlargement
• Root canal debridement and cleaning

Root Canal Disinfection (for use on adult and pediatric patients) - Laser root canal disinfection after endodontic treatment

EdgePro 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. EdgePro 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.

This 510(k) summary for the Biolase EdgePro laser system does not include a detailed study proving the device meets specific acceptance criteria for its intended clinical use. Instead, it relies on substantial equivalence to a predicate device (Waterlase Express) and non-clinical performance data.

Here's a breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., specific success rates for root canal preparation or disinfection) nor does it report specific clinical performance metrics for the EdgePro. The "performance" described is largely comparative to the predicate device in terms of technical characteristics and safety standards.

However, based on the "Comparison of EdgePro to Waterlase Express" table (Table 1) and the performance data section, we can infer some qualitative "acceptance criteria" through equivalence:

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

• Clinical Test Set: Not applicable. No clinical testing was performed for the EdgePro subject device. The device relies on equivalence to the predicate.
• Bench Testing: The document states "Testing was conducted to evaluate performance between the subject device and predicate device." However, it does not provide any details on the sample size (e.g., how many devices were tested, how many times each parameter was measured) or data provenance for this bench testing.
• Biocompatibility (for Predicate Device): Not specified.

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

Not applicable. No clinical test set with human subject data requiring expert ground truth establishment was conducted for the EdgePro in this submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical test data was collected from human subjects for the EdgePro subject device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "Clinical testing was not performed for the subject device since the indications for use are a subset of the predicate device and the performance characteristics are equivalent."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This device is not an AI/algorithm-only device. It is a laser surgical instrument. The software verification and validation would be considered a form of standalone performance assessment, but it's for the device's operational software, not an AI algorithm performing a diagnostic or prognostic task.

7. The Type of Ground Truth Used

• Biocompatibility: The ground truth would be accepted biological safety standards (e.g., ISO 10993-1) as demonstrated by laboratory tests for cytotoxicity, sensitization, intracutaneous reactivity, and systemic toxicity.
• Electrical Safety & EMC: Ground truth is defined by compliance with recognized international standards (IEC 60601 series).
• Software Verification & Validation: Ground truth is the device's functional specifications and FDA guidance for software in medical devices.
• Bench Testing: Ground truth is defined by the technical specifications of the device and comparative performance to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is a medical laser, not a machine learning model, so there is no "training set" in the context of AI.

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

Not applicable, as there is no training set for an AI/ML model.

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Dental Soft Tissue Indications
Incision, excision, vaporization, ablation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

• · Excisional and incisional biopsies
• · Exposure of unerupted teeth
• Fibroma removal
• · Frenectomy
• · Frenotomy
• · Gingival troughing for crown impressions
• · Gingivectomy
• · Gingivoplasty
• · Gingival incision and excision
• Hemostasis and coagulation
• · Implant recovery
• · Incision and drainage of abscess
• · Leukoplakia
• · Operculectomy
• · Oral papillectomies
• · Pulpotomy
• · Pulpotomy as an adjunct to root canal therapy
• Reduction of gingival hypertrophy
• · Soft-tissue crown lengthening
• · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
• · Vestibuloplasty
• · Tissue retraction for impression
• · Laser soft-tissue curettage
• · Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket

· Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility)

• · Reduction of bacterial level (decontamination) and inflammation
  • Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium

• · Lesion (tumor) removal

• · Removal of hyperplastic tissues

• · Laser assisted flap surgery

• · Removal of granulation tissue

Whitening

• · Light activation for bleaching materials for teeth whitening
• · Laser-assisted whitening/bleaching of teeth

Pain Therapy

· Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

The Epic 980 diode laser is a surgical and therapeutic device designated for a wide variety of oral soft-tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain.

The device uses a solid-state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the treatment site.

The laser is comprised of a base console, a wireless footswitch which activates the laser and a detachable delivery system consisting of a fiber optic cable, surgical handpiece and single-use disposable tips designed and optimized for different applications.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Biolase Epic 980 device.

This document describes a 510(k) premarket notification for the Biolase Epic 980, which is primarily a regulatory submission demonstrating substantial equivalence to already cleared predicate devices. As such, it relies heavily on the equivalence of the device's technical characteristics and previously cleared indications for use rather than new, extensive performance studies for the expanded indications.

Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with specific performance metrics is limited. Instead, the "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to the predicate devices, and the "study" is largely a comparison of specifications and previously cleared uses.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission, explicit "acceptance criteria" for the expanded indications are not defined in terms of performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the criterion for acceptance is that the device's technological characteristics and proposed expanded indications for use are substantially equivalent to those of legally marketed predicate devices, and these expanded indications have already been cleared.

The "reported device performance" is essentially that the Epic 980 shares the same core technological characteristics as the predicates and that, where parameters differ (like maximum power output), these differences do not lead to significantly different clinical performance for the specified indications.

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

The document explicitly states: "Since the expanded indications for use have been already cleared for equivalent devices, therefore any additional clinical and/or performance testing was not required."

This indicates that there was no new "test set" or study involving human subjects or specific performance data generated for this submission to prove the expanded indications. The "data provenance" for the original clearances of the predicate devices' expanded indications would be where this information implicitly lies, but it is not provided in this document. This submission relies on the existing clearances of the predicate devices.

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

Given the statement in point 2, there was no new test set and therefore no new "ground truth" established for this specific submission. The reliance is on the regulatory history and clearances of the predicate devices, which would have had their own evidence for their respective indications.

4. Adjudication Method for the Test Set

As there was no new test set for this submission, there was no adjudication method applied.

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 a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study was not applicable and not performed.

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

The Epic 980 is a physical laser device operated by a human. It is not a standalone algorithm. Therefore, no standalone (algorithm only) performance study was conducted.

7. The Type of Ground Truth Used

For this specific 510(k) submission, the "ground truth" for the expanded indications relies on the prior regulatory clearances of the predicate devices for those indications. The FDA deemed those predicate devices safe and effective for those uses based on their own submissions, which may have included clinical data, pre-clinical studies, and expert consensus at the time of their clearance.

8. The Sample Size for the Training Set

This document does not describe the development or training of a software algorithm that would typically require a "training set." While the device has software, it's for control and functionality, not for "learning" or "decision-making" in the sense of AI. Therefore, a "training set" in the context of an AI/machine learning algorithm is not applicable to this submission. Software verification and validation were performed as per IEC 62304:2015.

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

Given that a "training set" in the AI/ML context is not applicable, the method for establishing its "ground truth" is also not applicable. The software's performance was validated against its specifications and intended functions.

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1. Dental Soft Tissue Indications
   Incision, excision, vaporization, ablation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

• · Excisional and incisional biopsies
• · Exposure of unerupted teeth
• · Fibroma removal
• · Frenectomy
• · Frenotomy
• · Gingival troughing for crown impressions
• · Gingivectomy
• · Gingivoplasty
• · Gingival incision and excision
• · Hemostasis and coagulation
• · Implant recovery
• · Incision and drainage of abscess
• · Leukoplakia
• · Operculectomy
• · Oral papillectomies
• · Pulpotomy
• · Pulpotomy as an adjunct to root canal therapy
• · Reduction of gingival hypertrophy
• · Soft-tissue crown lengthening
• · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
• · Vestibuloplasty
• · Tissue retraction for impression
• 2. Laser Periodontal Procedures
• · Laser soft-tissue curettage
• · Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket
  · Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility)
• 3. Whitening
• · Light activation for bleaching materials for teeth whitening
• · Laser-assisted whitening/bleaching of teeth
• 4. Pain Therapy
     · Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

The Epic 980 diode laser is a surgical and therapeutic device designated for a wide variety of oral soft-tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain.
The Epic 980 uses an Indium Gallium Arsenide (InGaAs) solid-state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the treatment site.
A visible light is emitted at the same time to visually identify the treatment location. The laser is comprised of a base console, a wireless footswitch which activates the laser and a detachable delivery system consisting of a fiber optic cable, surgical handpiece and single-use disposable tips designed and optimized for different applications.

The provided text describes the 510(k) premarket notification for the Biolase Epic 980 device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting specific acceptance criteria and detailed performance of the subject device itself. Therefore, many of the requested data points (like sample size for test sets, ground truth establishment, MRMC study results, etc.) are not available in this document.

Here's an analysis based on the information provided:

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

The document does not explicitly define acceptance criteria as numerical targets for performance metrics in the way one might expect for an AI/ML device. Instead, the "acceptance criteria" are implied by the various tests and standards to which the device was found compliant, demonstrating safety and efficacy primarily through establishing equivalence to predicate devices. The "reported device performance" is mainly a statement of equivalency rather than specific numerical outcomes.

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

• Sample size for test set: Not specified for any of the tests.
• Data provenance: Not specified.

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 the document does not describe a study involving expert-established ground truth for a test set. The equivalency was based on objective technical standards and ex-vivo testing.

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

• Not applicable as the document does not describe a study involving adjudication for a test set.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a laser surgical instrument, not an AI diagnostic or assistance tool for human readers.

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

• No, this device is a physical laser instrument. The concept of "standalone algorithm only" is not applicable here. Performance was assessed through technical compliance and comparative ex-vivo testing.

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

• For biocompatibility, the ground truth is established through adherence to ISO 10993-1 biological evaluation methods.
• For electrical safety, EMC, laser safety, dental equipment safety, and usability, the ground truth is established by compliance with the specified IEC standards.
• For the ex-vivo bench testing, the "ground truth" was the performance of the predicate device, against which the subject device was compared for equivalency. The exact metrics for this comparison are not detailed beyond "the results demonstrate equivalency."

8. The sample size for the training set

• Not applicable. This device is a laser hardware system and not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As above, there is no "training set" for this type of device.

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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.

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The Epic Pro 940 with surgical laser operation (Automatic Power Control) used in contact mode, is indicated for dental soft tissue indication, incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingival; examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughening, removal of granulation tissue, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectorny, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

The Epic Pro 940 with surgical laser operation, used in contact mode, is intended for use in general surgery for incision, excision, vaporization, ablation and coagulation of soft tissue.

The Epic Pro 940 with dental laser operation is intended for incision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal gingiva and epithelial lining of free gingiva); examples include: frenectomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, hemostasis of donor site, treatment of aphthous ulcers, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, pulpotomy, as an adjunct to root canal therapy, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), light activation of bleaching materials for teeth whitening.

Epic Pro 940 diode laser system is a surgical device designated for a wide variety of surgical and oral soft-tissue procedures and dental whitening. Epic Pro 940 utilizes a solid-state diode as a semiconductor source for invisible infrared radiation. The energy is delivered to the treatment site via a flexible fiber connected at one end to the laser source and the other end to the handpiece. Various types of single use disposable tips are designed and optimized for different applications. The device is activated by means of a wireless footswitch.

The provided text is a 510(k) Summary for a medical device called "Epic Pro 940 Diode Laser System." It details the device's characteristics, indications for use, and a comparison to a predicate device ("Epic Pro"). The document focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving a new device meets acceptance criteria through a traditional clinical study with a test set, ground truth, and expert evaluation as would be done for an AI/ML-driven device.

Therefore, the following information regarding acceptance criteria, study design, and performance metrics for AI/ML devices is not available in this document:

• A table of acceptance criteria and reported device performance for an algorithm.
• Sample size used for a test set or data provenance for an algorithm.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone (algorithm-only) performance results.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Explanation Based on the Provided Document:

This 510(k) submission for the Epic Pro 940 Diode Laser System relies on demonstrating substantial equivalence to a predicate device (Epic Pro, K163128). The key change in the new device is the replacement of a 980nm diode laser module with a 940nm diode.

The document states:
"Epic Pro 940 is a modified version of Epic Pro (K163128). The change involved is limited to the replacement of the existing 980nm diode laser module, used in Epic Pro, with a 940nm diode in Epic Pro 940. Epic Pro 940 operates the same as the predicate device and the modification does not impact the intended use and indications for use."

Acceptance Criteria and Device Performance (in the context of substantial equivalence):

Instead of traditional "acceptance criteria" for a novel AI/ML algorithm's performance, the acceptance here is based on the new device performing as well as the legally marketed predicate device, and demonstrating that the change (wavelength) does not introduce new safety or efficacy concerns.

The "performance data" provided to support this claim focuses on:

• Biocompatibility Testing: Conducted according to ISO 10993-1. (Results "demonstrate biocompatibility").
• Electrical Safety and Electromagnetic Compatibility (EMC): Tested according to recognized standards (IEC 60601-1-2, IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 80601-2-60, IEC 62366-1, IEC 60601-1-6). The device "passed the required testing and is in full compliance with the standards."
• Software Verification and Validation: Performed according to IEC 62304 and FDA guidance.
• Bench Testing: "Ex-vivo animal tissue testing was performed to evaluate performance between the subject device and its predicate. The results demonstrate that Epic Pro 940 performs as well as the predicate device, Epic Pro."
• Clinical Testing: "Clinical testing was not performed for the subject device since the indications for use are the same as for the predicate device and the performance characteristics are equivalent."

Summary Table (Applying the prompt's structure to the available information):

In conclusion, this document is a 510(k) submission focused on demonstrating substantial equivalence of a modified laser device, not an AI/ML device that requires performance criteria based on a clinical test set with human expert consensus ground truth.

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The Epic Pro with surgical laser operation (Automatic Power Control) used in contact mode, is indicated for dental soft tissue indications incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva); examples include: frenectomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughening, removal of granulation tissue, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectorny, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

The Epic Pro with surgical laser operation, used in contact or non-contact mode, is intended for use in general surgery for incision, excision, vaporization, ablation and coagulation of soft tissue.

The Epic Pro with dental laser operation is intended for incision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal gingiva and epithelial lining of free gingiva); examples include: frenectomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, hemostasis of donor site, treatment of aphthous ulcers, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, pulpotomy, as an adjunct to root canal therapy, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), light activation of bleaching materials for teeth whitening.

Epic Pro diode laser system is a surgical device designed for a wide variety of surgical and oral soft tissue procedures and dental whitening.

Epic Pro utilizes a solid state diode as a semiconductor source for invisible infrared radiation. The energy is delivered to the treatment site via a flexible fiber connected at one end to the laser source and at the other end to the handpiece. Various types of single use disposable tips are designed and optimized for different applications. The device is activated by means of a wireless footswitch.

The provided text is a 510(k) Summary for the Biolase Epic Pro diode laser system. It outlines the device's technical specifications, its comparison to a predicate device (stLase, K111689), and the performance data submitted to support its substantial equivalence.

Here's an analysis to extract the requested information, noting that some details related to a "study proving acceptance criteria" (especially for AI/ML devices) are not applicable as this document describes a laser surgical instrument, not an AI/ML diagnostic tool.

1. Table of Acceptance Criteria and Reported Device Performance

For this device (a laser surgical instrument), "acceptance criteria" and "device performance" are typically related to meeting established safety and performance standards for medical devices, rather than accuracy metrics for an AI algorithm.

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

• Test Set Description: The "test set" in this context refers to samples used for bench testing of physical device performance, as clinical testing was not performed due to substantial equivalence claims.
• Sample Size: Not specified quantitatively. The document states "In-vitro testing was conducted on soft tissue." The number of samples of soft tissue is not provided.
• Data Provenance: Not explicitly stated, but "In-vitro testing" implies lab-based testing. It's not human patient data, so country of origin is less relevant than for clinical trials. It is retrospective in the sense that it's testing a completed device against a predicate.

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

• Not Applicable. As a laser surgical instrument, the assessment relies on engineering and biological testing against established standards and comparison to a predicate device, not on expert consensus for interpreting diagnostic images or clinical outcomes in the way an AI/ML diagnostic tool would.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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

• Not Applicable. This is not an AI/ML diagnostic device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

• Not Applicable. This is a physical medical device, not an algorithm, so the concept of "standalone performance" in this context is not relevant. The device operates as a tool used by a human practitioner.

7. Type of Ground Truth Used

• For Biocompatibility: Standardized biological assays according to ISO 10993-1.
• For Electrical Safety/EMC: Compliance with parameters defined in the listed IEC standards.
• For Software: Verification against software specifications and intended functions.
• For Bench Testing: Comparison of functional performance on in-vitro soft tissue against the performance of a predicate device (stLase) on similar materials. This represents a "functional ground truth" based on established laser principles and predicate device performance.

8. Sample Size for the Training Set

• Not Applicable. As this is a non-AI/ML device, there is no "training set" in the context of machine learning. The device is designed and tested through traditional engineering and material science methods.

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

• Not Applicable. See point 8.

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The Waterlase Express indications for use are as follows:

General Hard Tissue Indications (for use on adult and pediatric patients)

• · Class I, II, III, IV and V cavity preparation
• · Caries removal
• · Hard tissue surface roughening or etching
• · Enameloplasty, excavation of pits and fissures for placement of sealants

Root Canal Hard Tissue Indications

• · Tooth preparation to obtain access to root canal
• · Root canal preparation including enlargement
• · Root canal debridement and cleaning

Root Canal Disinfection

• · Laser root canal disinfection after endodontic treatment
  Endodontic Surgery (Root Amputation) Indications
• · Flap preparation incision of soft tissue to prepare a flap and expose the bone
• · Cutting bone to prepare a window access to the apex (apices) of the root(s)
• Apicoectomy amputation of the root end
• · Root end preparation for retrofill amalgam or composite
• · Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic

tissues (i.e., granulation tissue) from around the apex

NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.

Bone Surgical Indications

• · Cutting, shaving, contouring and resection of oral osseous tissues (bone)
• · Osteotomy

Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patient) Incision, vaporization, ablation and coagulation of oral soft tissues including:

• · Excisional and incisional biopsies
• · Exposure of unerupted teeth
• · Fibroma removal
• · Flap preparation incision of soft tissue to prepare a flap and expose the bone
• · Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth

(hard and soft tissue impactions)

• · Frenectomy and frenotomy
• · Gingival troughing for crown impressions
• Gingivectomy
• · Gingivoplasty
• · Gingival incision and excision
• · Hemostasis
• Implant recovery
• · Incision and drainage of abscesses
• · Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area

during apical surgery

• · Leukoplakia
• · Operculectomy
• · Oral papillectomies
• Pulpotomy
• · Pulp extirpation
• Pulpotomy as an adjunct to root canal therapy
• · Root canal debridement and cleaning
• · Reduction of gingival hypertrophy
• · Soft tissue crown lengthening
• · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
• · Vestibuloplasty
• · Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic

tissues (i.e., granulation tissue) from around the apex

NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.

Laser Periodontal Procedures

• · Full thickness flap
• · Partial thickness flap
• · Split thickness flap
• · Laser soft tissue curettage
• · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
• · Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium
• · Removal of granulation tissue from bony defects
• · Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
• · Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
• Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
• · Osseous crown lengthening
• · Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
• · Waterlase Er.Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.

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

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

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The Sample Size for the Training Set

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

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

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

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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 Epic 10 is intended for use as a laser surgical instrument requiring the incision, excision, vaporization, ablation and hemostasis, or coagulation of soft tissue. It is indicated for the following expanded Indications for Use: General Surgery, Dermatology, Plastic Surgery and Podiatry - Debridement of wounds.

The EPIC 10 system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The EPIC 10 laser is comprised of a base console, a detachable delivery system, tips, and a wireless footswitch. Various types of the single use tips are included for different applications and the device is activated by means of a wireless footswitch. The Epic 10 delivery system consists of the following: Fiber Optic Assembly, Surgical Handpiece, and Single-use tips.

The provided document is a 510(k) premarket notification for the Biolase Epic 10 laser surgical instrument, seeking to expand its Indications for Use to include "Debridement of wounds."

Here's an analysis of the acceptance criteria and study information, based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) submission process for a device that is substantially equivalent to a predicate device generally focuses on demonstrating that the new device is as safe and effective as the predicate. In this specific case, the submission is about expanding the Indications for Use for an already cleared device (Epic 10, cleared under K130465). Therefore, the "acceptance criteria" here are to demonstrate substantial equivalence to predicate devices that already have the "Debridement of wounds" indication.

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

• Sample Size: Not applicable. The submission explicitly states, "Clinical testing was not conducted on this device." Instead, substantial equivalence is claimed based on a comparison to predicate devices that already have the "Debridement of wounds" indication.
• Data Provenance: Not applicable, as no new clinical or non-clinical studies were performed for this specific 510(k) submission. The data provenance implicitly refers to the prior FDA clearances of the predicate devices (K100558, K072779, K060114), which would have involved their own testing.

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

• Not applicable. No new test set (clinical or otherwise) was generated for this expanded indication submission. The "ground truth" for the predicate devices' indications would have been established during their original clearance processes.

4. Adjudication Method for the Test Set

• Not applicable, as no new 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 laser surgical instrument, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a surgical instrument operated by a human, not an algorithm.

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

• Not applicable for this specific submission as no new testing was performed. The basis for clearance relies on the established "ground truth" and safety/effectiveness demonstrations of the predicate devices for the "Debridement of wounds" indication. For a surgical device, ground truth in design would typically involve engineering specifications, biocompatibility, electrical safety, and performance characteristics (e.g., power output, beam quality), validated against regulatory standards and possibly preclinical models. Clinical ground truth for efficacy would come from clinical trials or established medical practice.

8. The Sample Size for the Training Set

• Not applicable. The device is a surgical laser, not an AI model, so there is no "training set."

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

• Not applicable, as there is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria for this specific 510(k):

The "study" in this context is a comparison to legally marketed predicate devices that already carry the expanded indication. Biolase demonstrated that its Epic 10 device is "substantially equivalent" to these predicates for the indication "Debridement of wounds" by showing that:

• Predicate Devices: QUANTA Diode Laser Family (K100558), Ceralas D980 Diode Laser (K072779), and Vectra Laser System and Accessories (K060114) all include "Debridement of wounds" in their Indications for Use.
• Technological Characteristics: The Epic 10 shares similar fundamental technological characteristics (laser type, power delivery, general operating principles) with these predicate devices. The document includes a table comparing these characteristics, highlighting that while there might be differences in specific parameters (e.g., maximum power output), these are not considered to raise new questions of safety or effectiveness regarding the expanded indication when compared to the range and functionality of the predicate devices.
• Lack of New Testing: The submission explicitly states that "Non-clinical testing was not performed on this device since the purpose of this 510(k) is to only expand the Indications for Use from the previous 510(k) clearance... The indication included in this 510(k) has already been cleared by the FDA for equivalent medical devices..." and "Clinical testing was not conducted on this device."

Therefore, the "proof" is the argument of substantial equivalence based on the established safety and effectiveness of the identified predicate devices for the specified expanded indication.

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