The Diolase 980 D Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.

Device Description

The Diolase 980 D Diode Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingival) using a contact fiber optic delivery system.

AI/ML Overview

This document is a 510(k) Summary for the DioLase 980 D Diode Laser System and primarily focuses on establishing substantial equivalence to a predicate device rather than detailing studies with acceptance criteria for device performance in the way clinical diagnostic devices do.

Therefore, the requested information elements related to clinical studies, ground truth, expert adjudication, and effect size for AI models are not directly applicable or available in this type of submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (a dental laser system), "acceptance criteria" and "reported device performance" are primarily based on technical specifications and intended use matching or being substantially equivalent to a legally marketed predicate device.

Specifications	Acceptance Criteria (Predicate: BioLitec Smilepro 980)	Reported Device Performance (ADT Diolase 980 D)	Meets Criteria?
Intended Use	Same as predicate	Same as predicate	Yes
Wavelength	980 nm	980 nm	Yes
Output Power	15W	15W	Yes
Power Range	1-15W	.2-15W	Yes
Increments	1W	.2W - 1W	Yes
Operating Modes	Pulsed or Continuous	Pulsed or Continuous	Yes
Pulse Duration ON	.01 to 99.9 Sec.	.01 to 99.9 Sec.	Yes
Pulse Duration OFF	.01 to 99.9 Sec.	.01 to 99.9 Sec.	Yes
Aiming Beam	635 nm; 4mW; Red	635 nm; 4mW; Red	Yes
Cooling	Air Cooled	Air Cooled	Yes
Weight	15 lbs. (9 kg)	11 lbs. (5 kg)	(Better)
Dimensions	14" x 9" x 7"	14" x 9" x 3"	(Better)
Power Requirements	110/220 V	110/220 V	Yes

The "study that proves the device meets the acceptance criteria" in this context is the 510(k) Premarket Notification process, which demonstrates substantial equivalence to a predicate device. The comparison table above is the core of that "study." The FDA review concludes that the device "is substantially equivalent... to legally marketed predicate devices."

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

This document does not describe a "test set" in the context of clinical data or AI model evaluation. The "test" here involves comparing the technical specifications and intended uses of the new device against a predicate device. No patient data or clinical study data is detailed for this comparison.

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

Not applicable. No "ground truth" based on expert consensus for a test set is described. The "ground truth" for substantial equivalence is the existing regulatory approval and performance of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication process described for clinical or AI performance. The regulatory review process itself involves expert review by the FDA.

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 is a medical device (laser system) and not an AI/imaging algorithm that would typically involve human readers or MRMC studies.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate device (BioLitec Smilepro 980 nm Diode Laser) and the demonstration that the DioLase 980 D Diode Laser System, through its technical specifications and intended use, is sufficiently similar to the predicate device to warrant regulatory approval without new clinical trials.

8. The Sample Size for the Training Set

Not applicable. This document pertains to a physical medical device and its substantial equivalence to a predicate, not an AI model requiring a training set.

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

Not applicable. (See #8)

Summary

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K 023 547 510(k) Summary for DioLase 980 D Diode Laser System

1. SPONSOR

American Dental Technologies, Inc. 555 Bear Lane Corpus Christi, TX 78405

Roger Dartt, CEO Contact Person: 1-800-320-1050 Telephone:

October 11, 2002 Date Prepared:

2. DEVICE NAME

DioLase 980 D Laser System Proprietary Name: Common/Usual Name: Dental Laser System Classification Name: Laser Surgical Instrument

3. PREDICATE DEVICES

BioLitec Smilepro 980 nm Diode Laser

4. INTENDED USE

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5. DEVICE DESCRIPTION

6. BASIS FOR SUBSTANTIAL EQUIVALENCE

The Diolase 980 D Diode Dental Laser System has the same intended use and the same or substantially equivalent technical specifications and mechanism of action as compared with the named predicated devices. The comparison of specifications are as follows:

Specifications	Biolitec Smilepro 980	ADT Diolase 980 D
Wavelength	980 nm	980 nm
Output Power	15W	15W
Power Range	1-15W	.2-15W
Increments	1W	.2W - 1W
Operating Modes	Pulsed or Continuous	Pulsed or Continuous
Pulse Duration ON	.01 to 99.9 Sec.	.01 to 99.9 Sec.
Pulse Duration OFF	.01 to 99.9 Sec.	.01 to 99.9 Sec.
Aiming Beam	635 nm; 4mW; Red	635 nm; 4mW; Red
Cooling	Air Cooled	Air Cooled
Weight	15 lbs. (9 kg)	11 lbs. (5 kg)
Dimensions	14" x 9" x 7"	14" x 9" x 3"
Power Requirements	110/220 V	110/220 V

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, each head facing a different direction.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2003

Ms. Marcia Van Valen Regulatory Specialist American Dental Technologies, Inc. 12 Prairie Falcon Aliso Viejo, CA 92656

Re: K023547

Trade/Device Name: Diolase 980 D Diode Dental Laser System 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: January 15, 2003 Received: January 16, 2003

Dear Ms. Van Valen:

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. Marcia Van Valen

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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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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K 023547 510(K) Notification:

Device Name: Diolase 980 D Diode Dental Laser System

Indications for Use:

The following indications for use are the same as those approved on the predicate device. The DioLase 980 D Diode Dental Laser System is intended for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Diseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

K02354 510(k) Number -

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

American Dental Technologies, Inc. DioLase 980 D Diode Laser 510(k)

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.