The exlase™ dental diode laser system is currently used to perform various and The system uses advanced laser technology to dealer with a many and the Samment works of the Mas An Indium Gallium Arsenide Phosphorus solid-state laser diode emits infrared laser energy to the various oral soft tissues targeted during procedure. This energy is transmitted via a flexible fiberoptic cable to the handpiece that emits the energy to the targeted tissue site. A visible light is emitted at the same time to visually pinpoint the treatment location. The power output and pulse width may be adjusted to specific user requirements.

AI/ML Overview

The provided document is a 510(k) summary for the ezlase™ dental diode laser system, seeking to expand its indications for use to include teeth whitening. This type of regulatory submission often focuses on demonstrating substantial equivalence to predicate devices rather than presenting novel clinical study data with detailed acceptance criteria and performance metrics in the way a new, high-risk device might.

Based on the document provided, here's an analysis of the requested information:

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

The document does not explicitly define specific performance-based acceptance criteria for teeth whitening (e.g., a certain percentage improvement in shade, or a specific safety profile outcome) that the ezlase™ device was tested against. Instead, the "acceptance criteria" appear to be based on the principle of substantial equivalence to already cleared predicate devices for the same indications.

Acceptance Criteria (Implied): Substantial equivalence to predicate devices for the indications of "Light activation for bleaching materials for teeth whitening" and "Laser-assisted whitening/bleaching of teeth," demonstrated by similar principles of operation, technology, and intended use as devices already cleared by the FDA for these indications.
Reported Device Performance: The document states, "The indications requested by this 510(k) are the same as those previously cleared by the FDA for other equivalent devices. Substantial equivalency for the ezlase™ has been determined through comparison to previously cleared devices." This implies that the device's performance for the new indications is considered to be on par with the cleared predicate devices, without providing specific quantifiable performance metrics for the ezlase™ itself for these new indications.

2. Sample size used for the test set and the data provenance

The document does not report any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) because it relies on a substantial equivalence comparison rather than new clinical trials demonstrating performance for the expanded indications. The existing predicate devices' clearance likely involved relevant data, but that data is not presented here as a "test set" for the ezlase™ in this 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable or not provided in the document. As no new clinical study data with a specific 'test set' was presented for these expanded indications, there's no mention of experts establishing ground truth for such a set. The "ground truth" for substantial equivalence is based on the regulatory history and scientific understanding of the predicate devices.

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

This information is not applicable or not provided in the document, as no specific test set requiring adjudication of outcomes is presented for the ezlase™ device for the expanded indications.

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 information is not applicable. An MRMC study is relevant for diagnostic devices often involving human interpretation of images, especially when comparing AI assistance. The ezlase™ is a therapeutic laser device for teeth whitening, not a diagnostic imaging tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant in this context. There is no AI component mentioned in the device description.

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

This information is not applicable. The ezlase™ is a physical laser device operated by a human clinician, not a standalone algorithm.

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

The concept of "ground truth" in this 510(k) is primarily centered on regulatory precedent and established safety/efficacy of predicate devices. The "truth" is that the predicate devices have been deemed safe and effective for these indications by the FDA. The submission argues that the ezlase™ is substantially equivalent to these devices, implying its performance will be similar. No new direct "ground truth" measurements (like specific outcomes data for a clinical trial) are presented for the ezlase™ for these expanded indications.

8. The sample size for the training set

This information is not applicable or not provided. Since the submission relies on substantial equivalence and does not describe a machine learning algorithm, there is no "training set."

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

This information is not applicable or not provided for the same reasons as #8.

Summary

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CONFIDENTIAL

.082938 Pa

Biolase Technology, Inc. Special 510(k) Summary Statement ezlase™ Expanded Indications for Use

	510(k) Summary(As required by 21CFR807.92)
Date Prepared:	October 1, 2008
	DEC 22 2008
Company:	Biolase Technology, Inc.4 CromwellIrvine, CA 92618Tel: (949) 361-1200Fax: (949) 273-6680
Contact:	Ms. Ioana M. RizoiuVP, Clinical R&DTel: (949) 226-8144email: irizoiu@biolase.com
Trade Name:	ezlase™
Common Name:	Dental Diode Laser
Classification Name:	Surgical laser instrument
Classification Code:	79 GEX, a Class II device
Predicate Devices:	TwilightTMBiolase Technology, IncCeralas D Diode Laser SystemsCeramoptic, Inc. (Biolitec, Inc.)VectraTMXintec Corp., DBA Convergent Laser Technologies

DEVICE DESCRIPTION:

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Image /page/1/Picture/0 description: The image shows the text "K082938" written in a handwritten style, with a line drawn underneath it. Below the line, the word "CONFIDENTIAL" is written in bold, capitalized letters. The text appears to be part of a document or label, possibly indicating a confidential code or reference number.

Page (2) of (2)

INDICATIONS FOR USE:

This device may be used for the following indications:

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

CONTRAINDICATIONS:

All clinical procedures performed with the ezlase"M 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, which might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, lung disorders, sleep apnea, and immune system deficiency, or any medical conditions or medications that may contraindicate use of certain light/laser type sources associated with this device. Medical clearance from the patient's physician is advisable when doubt exists regarding treatment.

SUBSTANTIAL EQUIVALENCE:

The purpose of this 510(k) is to expand the current exlase™ indications for use (K061898) to include teeth whitening, an indication already cleared by the FDA for equivalent medical devices as part of the following 510(k) submissions: K003385 (Twilite™), K993002, K050824, K072106, (Ceralas D laser systems), and K060114 (Vectra™). Based on this comparison, the ezlase™ is substantially equivalent in relation to previous cleared devices.

CONCLUSION:

The indications requested by this 510/k) are the same as those previously cleared by the FDA for other equivalent devices. Substantial equivalency for the ezlase™ has been determined through comparison to previously cleared devices.

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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 is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biolase Technology, Inc. % Ms. Ioana M. Rizoiu VP, Clinical R & D 4 Cromwell Irvine, California 92618

DEC 2 2 2008

Re: K082938

Trade/Device Name: ezlase™ Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 16, 2008 Received: December 17, 2008

Dear Ms. Rizoiu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 M. Rizoiu

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K

Device (Trade) Name: ezlase™

Indications for Use:

Light activation for bleaching materials for teeth whitening
K082938
Laser-assisted whitening/bleaching of teeth
Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dind Krone la MXM 12/22/2005

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

510(k) Number USQ935

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.