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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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Use of the device is indicated for the incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing. Use of the device is further indicated for the incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision, tissue disection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coadulation may be indicated

The DermaLase ™ laser system consists of two main components: the laser module and the delivery system. The Laser Module contains the laser resonator cavity, power supplies, closed loop internal cooling system and TTCS™ tissue irrigation and cooling module. Microelectronics circuits and system Control Panel are housed inside the laser console as well. The Control Panel provides access to all system controls. Actions are initiated through a touch sensitive membrane keypad. The display screen is back lighted for easy viewing. BioLase currently offers two options for laser energy delivery: a fiber optic based delivery system and an articulated arm based delivery system. The fiber optic system utilizes either a contact or non-contact hand piece. The articulated arm based delivery system utilizes either a contact or non-contact point delivery hand piece.

The provided text is a 510(k) summary for the DermaLase™ laser system, which focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics in the way a clinical trial for a new drug or a novel AI diagnostic device would.

Therefore, the requested information cannot be fully extracted as there is no detailed study described that measures the device's performance against pre-defined acceptance criteria with specific metrics like sensitivity, specificity, or inter-rater reliability. The 510(k) process for this device relies on demonstrating that the DermaLase™ is as safe and effective as other legally marketed devices, primarily the Elmer™ laser system (K952118), and other similar erbium lasers.

Here's a breakdown of what can be inferred or directly stated from the provided document, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. A 510(k) summary for a device like a surgical laser typically focuses on comparing its technical specifications and intended use to predicate devices, rather than establishing numerical performance metrics against acceptance criteria.

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

This information is not applicable/not available. The document does not describe a "test set" in the context of evaluating the device's performance against a gold standard for a specific medical outcome. The submission relies on a comparison of device specifications and indications for use with predicate devices.

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

This information is not applicable/not available. The document does not describe a study involving human readers or experts establishing ground truth for a test set.

4. Adjudication Method:

This information is not applicable/not available. There is no adjudication method described as no study involving human assessment of results is mentioned.

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

This information is not applicable/not available. The document does not describe a MRMC study or any study comparing human readers with and without AI assistance. The DermaLase™ is a surgical laser, not an AI diagnostic device.

6. Standalone Performance:

This information is not applicable/not available in the sense of an algorithm's standalone performance. The document describes the device itself and its equivalence to other lasers. Its "standalone performance" is inherent in its technical specifications (wavelength, power, frequency) which are deemed equivalent to predicate devices.

7. Type of Ground Truth Used:

This information is not applicable/not available in the context of a performance study. For this type of 510(k) submission, the "ground truth" is essentially established by the safety and effectiveness profile of the predicate devices. The claim is that the new device operates similarly and therefore achieves similar clinical outcomes as the predicates.

8. Sample Size for the Training Set:

This information is not applicable/not available. Training sets are relevant for machine learning algorithms. The DermaLase™ is a physical surgical laser, not an AI system that requires a training set.

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

This information is not applicable/not available as there is no training set for this type of device.

Summary derived from the provided text regarding Substantial Equivalence:

The DermaLase™ laser system's acceptance criteria are implicitly defined by its substantial equivalence to existing, legally marketed devices. The study proving this involves a comparison of its technical specifications and intended uses to those predicate devices.

Predicate Devices:

• CB Erbium/2.94 (Continuum Biomedical, Inc.) - K961748
• Trilase 2940™ Erbium laser system (Schwartz Electro-Optics) - K954013
• MCL 29 Dermablate™ (Aesculap-Meditec) - K964128
• Elmer™ (BioLase Technology, Inc.) - K952118 (mentioned as almost identical)

Key Aspects of Comparison (implicitly the "study" for 510(k)):

• Wavelength, Power, and Frequency: The DermaLase™ produces laser light at the exact same wavelength, power, and frequency as the Elmer™ (K952118). This is a primary technical equivalence point.
• Tissue Irrigation and Cooling System: The DermaLase™ includes BioLase's Target Tissue Cooling System™ for tissue cooling and irrigation, which is equivalent to that found in the Elmer™ (K952118).
• Indications for Use: The DermaLase™ is indicated for "incision, excision, ablation, vaporization and hemostasis of soft tissue." The submission states that similar indications for use are shared with predicate devices like those from Schwartz Electro-Optics, Continuum Biomedical, and Aesculap-Meditec. The specific expanded indications listed in the FDA's "Indications For Use" form include dermatologic tissues and general surgical applications (incision, excision, vaporization, coagulation of soft tissue, etc.).
• Safety and Effectiveness: The conclusion drawn is that because the DermaLase™ shares similar performance specifications, design, and indications for use with legally marketed predicate devices, it is considered as safe and effective.

Conclusion:

The provided 510(k) summary does not contain the detailed performance study information with explicit acceptance criteria, sample sizes, and ground truth methodologies typically associated with clinical trials or AI device evaluations. Instead, the "study" is a demonstration of substantial equivalence through a comparison of the DermaLase™'s design, technical specifications, and intended uses to those of predicate devices already cleared for market.

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