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).

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria	Reported Device Performance
Not explicitly stated and quantified in this document. The overarching criterion is "substantially equivalent in terms of safety and efficacy" to predicate dental handpieces.	Not explicitly reported in quantifiable metrics against specific acceptance criteria in this document.

Additional Study Information:

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.
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.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided in the document.
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.
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.
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.).
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.
How the ground truth for the training set was established:
- Not applicable / Not provided in the document. As per point 7.

Summary

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FEB 1 2 2002

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

K013908

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REGULATORY Safe Medical Devices Act of 1990, 21 CFR 807.92 AUTHORITY: COMPANY: BioLase Technology, Inc. 981 Calle Amanecer San Clemente, California 92673 Ms. Ioana M. Rizoiu CONTACT: BioLase Technology, Inc. 981 Calle Amanecer San Clemente, California 92673 (949) 361-0204 Fax (949) 361-1200 TRADE NAME: Waterlase Millennium COMMON NAME: Hydrokinetic tissue cutting system CLASSIFICATION NAME: Hydrokinetic device 79 MXF CLASSIFICATION CODE: EQUIVALENT DEVICES: Dental handpiece Dentsply Dental handpiece Star Dental

DEVICE DESCRIPTION:

Dental handpiece

Siemens

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

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013908 4/2

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.

INDICATIONS FOR USE:

Class I. II. III. IV and V cavity preparations

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)

CAUTIONS AND CONTRAINDICATIONS:

All clinical procedures performed with Waterlase™ Millennium® must be subjected to the same clinical judgment 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:

The clinical results reported in this Premarket Notification and Feature Comparison Table demonstrate that Waterlase Millennium is substantially equivalent to the Dental handpiece in terms of safety and efficacy.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2002

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

Re: K013908

Trade Name: Waterlase® Millennium™ Regulation Number: 872.4120 Regulation Name: Bone cutting instrument & accessories Regulatory Class: II Product Code: MXF; DZI Dated: November 21, 2001 Received: November 26, 2001

Dear Ms. Rizoiu:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your boouse resired the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to Indications for use stated in the ensical Device Amendments, or to devices that have May 20, 1970, the chaounten cause of the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, (Act) that do not require upper to the general controls provisions of the Act. The general therefore, marker the devices to excepted to expective to annual registration, listing of devices, Controls provisions of the receiner, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device 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 be found in the Oous cereents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Driversion that your device complies with other requirements of the Act that I DF nas Inade a actor regulations administered by other Federal agencies. You must or any I caelar suatures and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT an 0077, idoling (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quanty byeveline (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 5 10(k) I his retter will anow you to begin manieting your maneling of your device to a legally premarket nothleadon: "The PDF miding of casification 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 article for your acvitoo diagnostic devices), please contact the Office of additionally 21 CFK Patt 807.10 for mi viac c.d.p.m. c.c.p.m.p.m.promotion and advertising of Compliance at (301) 594-4057. Additionally (6) 404-4639. Also, please note the your device, picase comate and of interest to premarket notification™ (21CFR Part 807.97). It general information on your responsibilities under the Act may be obtained from the Other general information on your 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,

iriam C. Provost

for 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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510(k) Number (if known): K O / 3 90 J

Device Name:

Waterlase®Millennium™

Indications for Use:

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).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use

Muriam C. Provost

(Division Sign-Off) Division of General Restorative and Neurological Devices

510(k) Number K013908

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.