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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.
Cutting, shaving, contouring and resection of oral osseous tissues (bone).

The Waterlase™ Millennium® hydrokinetic tissue cutting system is a diverse instrument for performing several dental applications. Waterlase™ Millennium® utilizes advanced laser and water atomization technologies to incise, excise and ablate intraoral soft and hard tissues safely and effectively. An erbium, chromium, yttrium, scandium, gallium garnet (Er, Cr.YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result. The hydrokinetic process refers to the removal of tissues with laser energized water particles. Strong absorption of laser energy by atomized water droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, yielding quick and clean mechanical tissue removal. A flexible fiberoptic handpiece delivers the Waterlase™ Millennium's® unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.

The provided FDA 510(k) summary for the BioLase Waterlase Millennium focuses on demonstrating substantial equivalence to predicate devices, primarily traditional dental handpieces. As such, it does not contain the typical information one would expect for a study proving a device meets specific acceptance criteria using quantitative metrics like sensitivity, specificity, or accuracy.

The summary references "clinical results reported in this Premarket Notification," but it does not detail these clinical studies in a granular way that would allow for the extraction of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, or expert adjudication.

Therefore, for almost all of the requested categories, the answer is "Not provided in the document."

Here is the breakdown based on the provided text:

Acceptance Criteria and Device Performance Study (Not Provided in Detail)

The document asserts "Waterlase Millennium is substantially equivalent to the Dental handpiece in terms of safety and efficacy," based on "clinical results reported in this Premarket Notification and Feature Comparison Table." However, specific quantitative acceptance criteria (e.g., minimum percentage of successful cavity preparations, a defined tissue removal rate, or reduction in patient discomfort scores) are not explicitly stated. Likewise, the "reported device performance" against such criteria is also not detailed.

Additional Study Information:

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

   • Not provided in the document. The document mentions "clinical results reported in this Premarket Notification" but does not detail the size or nature of the test set, nor its provenance.

2. 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 provided in the document. The means by which any clinical study data was evaluated or ground truth established (if applicable to the study type) are not described.

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

   • Not provided in the document.

4. 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 surgical instrument (hydrokinetic tissue cutting system) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to readers improving with AI assistance would not be relevant.

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

   • Not applicable. This is a medical device for direct clinical use, not an algorithm.

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

   • Not provided in the document. The clinical results mentioned are not detailed enough to ascertain the type of ground truth (e.g., direct observation of tissue removal, patient outcomes, success of cavity preparations, etc.).

7. The sample size for the training set:

   • Not applicable / Not provided in the document. As this is not an AI/machine learning device, there wouldn't typically be a "training set" in the sense of data used to train an algorithm. If "training set" refers to data used for initial development or pilot studies, it is not described.

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

   • Not applicable / Not provided in the document. As per point 7.

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Tooth preparation to obtain access to the root canal Pulpotomy Pulp extirpation Pulpotomy as an adjunct to root canal therapy Root canal debridement and cleaning Root canal preparation including enlargement

The Waterlase Millennium dental laser system may be used to perform several dental applications. For hard tissue procedures the Waterlase Millennium utilizes the Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet (Er,Cr:YSGG) laser in combination with advanced water atomization technology to cut, remove, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er,Cr.YSGG laser energy is applied to incise, excise or ablate the tissues. In soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues clean. A flexible fiberoptic handpiece delivers the Waterlase Millennium laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. In both hard and soft tissue applications the power output, pulse energy, repetition rate and air and water flow rates are adjustable to specific user requirements.

The provided text is a 510(k) Summary for the Waterlase Millennium dental laser system. This type of submission focuses on demonstrating "substantial equivalence" to predicate devices already on the market, rather than conducting new clinical trials to establish acceptance criteria for novel device performance. As such, the document does not contain the detailed study information typically associated with acceptance criteria and clinical performance studies for AI/ML-based devices.

Here's an analysis based on the information provided, highlighting why many aspects of your request cannot be fulfilled:

Acceptance Criteria and Reported Device Performance

The document states:
"Evidence of equivalence has been demonstrated through:

• Equivalent performance specifications
• Promotional materials for equivalent systems
• Equivalent intended uses"

This indicates that the "acceptance criteria" are based on matching the performance of predicate devices, rather than defining new, quantifiable performance metrics for this specific device in a standalone study. The document does not provide a table of specific acceptance criteria or reported device performance metrics in the way one would expect for an AI/ML device (e.g., sensitivity, specificity, AUC).

Instead, the "performance" demonstrated is the ability to achieve the same results as existing tools.

Study Information (as requested for AI/ML devices)

Many of the requests for study information are not applicable or cannot be answered from this 510(k) summary, as it is a submission for a physical medical device (laser system) and not an AI/ML diagnostic or prognostic tool.

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

   • Acceptance Criteria: Not explicitly stated as quantifiable metrics. The overarching criterion is "substantial equivalence" to predicate devices in performance specifications and intended uses.
   • Reported Device Performance: Not reported in terms of specific clinical metrics (e.g., success rates, complication rates) from a dedicated study for the Waterlase Millennium. The document implies performance is equivalent to predicate devices.

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

   • Not applicable / Not provided. The 510(k) summary does not describe a test set or data provenance from a prospective or retrospective study to validate performance against specific criteria. It relies on the established performance of predicate devices.

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 / Not provided. No ground truth establishment is described for a test set, as this is not a study aiming to establish the accuracy of a diagnostic or prognostic output.

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

   • Not applicable / Not provided. No adjudication method is described, as there is no test set for diagnostic accuracy assessment.

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 system for dental procedures, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant and not performed.

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

   • Not applicable. This is a physical device that requires direct human operation; it is not an algorithm.

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

   • Not applicable. No ground truth in this context is described, as the submission relies on substantial equivalence rather than primary clinical data collection and comparison against a ground truth.

8. The sample size for the training set:

   • Not applicable / Not provided. This is not an AI/ML device that undergoes training with a dataset.

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

   • Not applicable / Not provided. This is not an AI/ML device that requires ground truth for training.

Summary of How the Device Meets Acceptance Criteria

The Waterlase Millennium dental laser system meets its "acceptance criteria" by demonstrating "substantial equivalence" to legally marketed predicate devices through:

• Equivalent Performance Specifications: This implies that the technical specifications (e.g., laser wavelength, power output, pulse energy, repetition rate, and air/water flow rates) of the Waterlase Millennium are comparable to those of the predicate devices for the same intended uses.
• Equivalent Intended Uses: The indications for use for the Waterlase Millennium (e.g., tooth preparation, pulpotomy, root canal debridement and cleaning, root canal preparation including enlargement) are the same as those cleared for the predicate devices.
• Promotional materials for equivalent systems: While not a "study" in the traditional sense, this likely refers to referencing existing marketing claims and clinical literature (not provided in this summary) that support the predicate devices' efficacy for the stated indications.

Conclusion: The provided text is a 510(k) summary for a physical medical device (dental laser), not a software or AI/ML device. Therefore, the questions related to AI/ML device study design (e.g., test sets, training sets, ground truth establishment by experts, MRMC studies) are not applicable to this document. The device meets its "acceptance criteria" by demonstrating substantial equivalence to pre-existing, legally marketed predicate devices based on comparable performance specifications and intended uses, rather than through a dedicated clinical study with defined performance metrics and ground truth.

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For use on adult and pediatric patients for the following:

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

The Millennium™ hydrokinetic tissue cutting system is a diverse instrument for performing several dental applications. Millennium™ utilizes advanced laser and water atomization technologies to incise, excise and ablate intraoral soft and hard tissues safely and effectively. An erbium, chromium, yttrium, scandium, gallium garnet (Er, Cr:YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result.

The hydrokinetic process refers to the removal of tissues with high speed, atomized water particles. Strong absorption of laser energy by atomized water droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, vielding quick and clean mechanical tissue removal.

A flexible fiberoptic handpiece delivers the Millennium™s unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.

This document describes the BioLase Technology, Inc. Millennium™ hydrokinetic tissue cutting system, intended for various dental applications.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative "acceptance criteria" for the Millennium™ device in terms of specific performance metrics (e.g., specific percentages for accuracy, sensitivity, or specificity). Instead, substantial equivalence to existing predicate devices (dental handpieces, microetchers) is demonstrated through a feature comparison table and qualitative statements regarding safety and efficacy.

The basis for acceptance is stated as "substantially equivalent" to predicate devices, which implies that the device performs with comparable safety and efficacy for its intended use.

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

The document states: "reported results from multi-phase in-vitro and in-vivo clinical trials and Feature Comparison Table demonstrate that Millennium™ is substantially equivalent..." and "Safety and efficacy have been demonstrated through in-vitro, in-vivo and clinical trials on animals and humans."

• Test Set Sample Size: The specific sample sizes for the in-vivo human clinical trials are not provided in the summary.
• Data Provenance: The document does not specify the country of origin for the data. The studies performed include both in-vitro and in-vivo (on animals and humans), indicating a mix of pre-clinical bench testing and prospective clinical investigation. The term "reported results" suggests the studies were already completed at the time of submission (retrospective for the submission itself, though the trials were prospective).

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

This information is not provided in the document. The summary broadly refers to "clinical evaluation in randomized, double-blinded trials" but does not detail the process or experts involved in establishing ground truth for the clinical outcomes.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

An MRMC study is not applicable to this type of device (a dental cutting system). The device itself performs a physical action, not an interpretative task requiring human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

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

This is not applicable as the Millennium™ is a physical surgical device, not an AI algorithm. Its performance is always a "human-in-the-loop" scenario, as a dentist or dental professional operates it.

7. Type of Ground Truth Used

The ground truth for the performance of the Millennium™ device appears to be based on:

• Clinical Evaluation: Outcomes from "randomized, double-blinded trials" on humans, assessed by clinicians to determine safety and efficacy (e.g., caries removal, cavity preparation success, patient comfort, extent of tissue removal).
• Pulp Temperature Studies: Objective physiological measurements to ensure safety (e.g., avoiding thermal damage).
• Scanning Electron and Optical Microscopy: Objective imaging to assess the quality of tissue cutting and surface preparation, and potentially to corroborate efficacy.
• Equivalent Performance Specifications: Comparison to established predicate devices based on their known performance.

8. Sample Size for the Training Set

This is not applicable as the Millennium™ is a physical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable as the Millennium™ is a physical device, not an AI/ML algorithm.

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Class I - V cavity preparation
Caries removal
Hard tissue surface roughening or etching

The Millennium™ hydrokinetic tissuc cutting system is a diverse instrument for Pine Millennium - Hydrokins. Millennium™ utilizes advanced laser and performing coverer. comologies to incise, excise and ablate intraoral soft and hard water alonitation totatively. An erbium, chromium, yttrium, scandium, gallium gamet (Er, Cr.YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result.

The hydrokinetic process refers to the removal of tissues with high speed, atomized water particles. Strong absorption of laser energy by atomized water droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, yielding quick and clean mechanical tissue removal.

A flexible fiberoptic handpiece delivers the Millennium™s unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.

Based on the provided text, the document describes a 510(k) submission for the Millennium™ hydrokinetic tissue cutting system, where the primary objective is to demonstrate substantial equivalence to existing dental devices, rather than establishing specific acceptance criteria for a new, unique performance metric. Therefore, the "acceptance criteria" discussed are largely qualitative and based on equivalence to predicate devices, and the "study" is a collection of various tests and comparisons to support this equivalence.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text for certain categories:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria in the form of thresholds for specific performance metrics (e.g., "device must achieve X accuracy"). Instead, the "acceptance criteria" are implied through the concept of "substantial equivalence" to predicate devices for aspects like safety, efficacy, indications for use, materials, and mechanical cutting mode.

Study Details

The provided text describes a submission for substantial equivalence. It does not detail a single, self-contained study with a specific "test set" or "training set" in the context of an AI/algorithm-driven device as your questions imply. Instead, it refers to various forms of evaluation.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a single numerical value. The document refers to "multi-phase in-vitro and in-vivo clinical trials on animals and humans," but no specific sample sizes for these trials are provided.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The trials mentioned are "clinical trials," implying human (and animal) subjects, but the location is not specified. They are "retrospective or prospective" for efficacy, but the document does state "Clinical evaluation in randomized, double-blinded trials" which typically implies prospective and controlled studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The document refers to "clinical evaluation" and "clinical judgment and care," implying dentists/clinicians, but no specific number or detailed qualifications of experts establishing ground truth for the test set are given.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated.

4. 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 physical hydrokinetic tissue cutting system, not an AI or imaging diagnostic tool that would involve "human readers" or "AI assistance" in the sense of a diagnostic interpretation task.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The Millennium™ is a medical device used by a human operator (clinician). The concept of "standalone algorithm performance" does not apply here.

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

   • For the "clinical trials," the ground truth would likely involve clinical assessment of treatment efficacy (e.g., success of caries removal, cavity preparation, tissue excision) and safety outcomes (e.g., pulp temperature, patient comfort/healing). These assessments would be performed by clinicians, potentially with supporting diagnostic information (e.g., imaging, clinical observation).
   • For "pulp temperature studies," the ground truth is objective temperature measurement.
   • For "Scanning Electron and Optical Microscopy," the ground truth is the observable structural changes in tissue.

7. The sample size for the training set: Not applicable. This is not an AI/machine learning device with a distinct "training set." The development would have involved iterative design and testing, but not a formally defined machine learning training set.

8. How the ground truth for the training set was established: Not applicable, as there's no "training set" in the context of AI/machine learning. For the development of the device, engineering and clinical validation would be based on established scientific principles and clinical observations.

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