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

Device Description

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.

AI/ML Overview

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.

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.
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.
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.
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.
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.
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.
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.
The sample size for the training set:
- Not applicable / Not provided. This is not an AI/ML device that undergoes training with a dataset.
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.

Summary

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510(k) Summary of Safety and Effectiveness Information

RegulatoryAuthority:	Safe Medical Devices Act of 1990,21 CFR 807.92
Company:	BioLase Technology, Inc.
	981 Calle Amanecer
	San Clemente, CA 92673
Contact:	Ms. Ioana M. Rizoiu
	BioLase Technology, Inc.
	981 Calle Amanecer
	San Clemente, CA 92673
	(949) 361-1200	(949) 361-0204 Fax
Trade Name:	Waterlase Millennium ®
Common Name:	Er,Cr:YSGG laser
Classification Name:	Surgical laser instrument
Classification Code:	79 GEX
Equivalent Devices:
BioLase Technology, Inc.		Twilite™Millennium ®
Premier Laser Systems		Aurora™
Tycom Dental		Quantec Series 2000 Files
Tulsa Dental		Tri Auto ZX

Device Description:

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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.

Please refer to the User Manual, section 8 Applications', for detailed instructions on how to use the Waterlase Millennium device.

Indications for Use:

Cautions and Contraindications:

All clinical procedures performed with Waterlase Millennium must be subjected to the same clinical judgement and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment. Exercise caution for general medical conditions that might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, lung disease, bleeding disorders, sleep apnea or an immune system deficiency. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.

Substantial Equivalence:

There are no unique applications, indications, materials or specifications presented herein. For all the soft tissue indications for use, Waterlase Millennium is substantially equivalent to several erbium laser systems and diode laser systems cleared by the FDA. Equivalent devices include: BioLase, Twilite (K991994, for oral soft tissues including pulpotomy and pulpotomy as an adjunct to root canal therapy): Premier, Aurora (K981379, for pulpotomy and pulpotomy as an adjunct to root canal therapy); BioLase, Millennium (K980585 and K990219 for hard tissue applications); Tycom Dental, Quantec Series 2000 Endodontic Files (K962031 for root canal

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preparation) and Tulsa Dental Products, Tri Auto ZX (K970339 for endodontic treatment to enlarge root canals).

Conclusion:

Waterlase Millennium is substantially equivalent to several available, established dental laser products and endodontic files driven by rotary handpieces. Waterlase Millennium performs the same indications for use through the same cutting modalities as other laser devices and endodontic files.

· Evidence of equivalence has been demonstrated through:

· Equivalent performance specifications
Promotional materials for equivalent systems
· Equivalent intended uses

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Image /page/3/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an emblem featuring a stylized depiction of an eagle or bird with three wing-like shapes, which is a common symbol associated with the HHS.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2002

BioLase Technology, Inc. Iona Rizoiu Vice President Clinical Research and Development 981 Calle Amanecer San Clemente, California 92673

Re: K012511

Trade Name: Waterlase Millennium@ Regulation Number: 807.92 Regulation Name: Surgical Laser Instrument Regulatory Class: II Product Code: MXF; GEX Dated: November 12, 2001 Received: November 15, 2001

Dear Ms. Rizoiu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Ioana Rizoiu

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will anow you to ough finding of substantial equivalence of your device to a legally premarket notication. The PDF misting of cation for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice to: you invitro diagnostic devices), please contact the Office of additionally 21 CF F Fart 007.10 for minutes for questions on the promotion and advertising of Compliance at (301) 594-1097 Office of Compliance at (301) 594-4639. Also, please note the your device, prodo of thereading by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oincl general information on Jour respectional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Mellema

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):

WaterLase Millennium® Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
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Over-The-Counter-Use

Mark A Millhum

(Division Sign-Off)

Division of General, Restorative and Neurological Devices તે કે

5 %) Number

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.