The Opus 10TM Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening.

The Indications for Use of the Opus 10™ Dental Diode Laser System include:

Cosmetic Dentistry

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

Endodontology

Pulpotomy
Pulpotomy as an adjunct to root canal therapy

Periodontology

Sulcular debridement (removal of diseased or inflamed soft tissue in the periodental pocket)
Oral Soft Tissue Surgery
Biopsy
Operculectomy
Gingivectomy
Gingivoplasty
Papillectomy
Lesion (tumor) removal
Leukoplakia
Treatment of aphthous ulcers
Fibroma removal
Frenectomies and frenotomies
Tissue retraction for impressions
Incising and draining of abscesses
Exposure of unerupted teeth

Device Description

The Opus 10TM Dental Diode Laser is designed to perform several medical procedures in the oral soft tissue and to perform laser assisted aesthetic tooth whitening procedures.

A Gallium Aluminum Arsenide (GaAIAs) solid state laser diode provides optical energy to oral soft tissues.

A fiber optic held by an handpiece delivers the Opus 10™ laser energy. A visible light emitted from the handpiece's distal end targets the area of treatment. The optical power output and pulse may be adjusted to specific use requirements.

AI/ML Overview

The provided text is a 510(k) Summary for the Opus 10TM Dental Diode Laser System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with specific acceptance criteria as you would find for a de novo submission or a PMA.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, or comparative effectiveness studies in the way you've outlined. The device is not an AI/ML device, and thus those types of studies would not be applicable.

However, I can extract the relevant information regarding how the device's performance and safety were demonstrated for its substantial equivalence claim, aligning with the spirit of your request as much as possible for this type of document.

Here's a breakdown of what the document does provide:

Acceptance Criteria and Reported Device Performance:
- This document doesn't list specific quantitative acceptance criteria (e.g., ≥ X% sensitivity) or reported performance metrics (e.g., "The device achieved Y% sensitivity").
- Instead, the "acceptance criteria" are implied by compliance with regulatory and voluntary standards, and by demonstrating substantial equivalence to predicate devices in terms of technological characteristics, performance, intended use, and indications for use.
- "Reported Device Performance" in this context refers to its ability to meet the general performance expectations of the predicate devices and comply with relevant standards.

Acceptance Criterion (Implied)	Reported Device Performance
Compliance with U.S. Federal Performance Standards	Complies with 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products.
Compliance with European Medical Directive 93/42/EEC	Complies with Annex II of 93/42/EEC.
Compliance with Voluntary Standards	Complies with EN 60601-1, EN-60825-1, EN-601-2-22, CISPR 11, IEC 61000-4-2/3/4/5, EN55011, and IEC 801-2.
Substantial Equivalence to Predicate Devices (Opus 10TM, Twilite™, Aurora™, Dentek™ LD 15 Laser) in terms of:
- Intended Use / Indications for Use	- "The Opus 10TM intended use and indications for use were previously cleared by FDA for the predicate devices."
- Technical Characteristics	- "The technical characteristics of the Opus 10™ with the tooth whitening application are similar to those of the cleared Opus 10TM, Twilite™, Aurora™ and Dentek™."
- Laser Output Values	- "Laser output values of the Opus 10™ are well within previous cleared values of the predicate dental diode laser systems as described."
- Safety and Effectiveness	- "The predicate devices and other previous cleared lasers with similar energy output has a proven safety and effectiveness in the treatment of the claimed indications."
- Overall Safety and Performance	- "Safety and performance testing." (General statement, no specific results provided.)
- No new safety and/or effectiveness issues	- "raises no new safety and/or effectiveness issues."

Sample size used for the test set and the data provenance: Not applicable. This 510(k) summary does not describe a clinical study with a "test set" in the context of an FDA clearance for an AI/ML device. The "testing" referred to is against engineering and safety standards, and comparative analysis to predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no "test set" or ground truth established in the sense of an AI/ML algorithm evaluation. The document states that the predicate devices have "proven safety and effectiveness," implying prior regulatory review.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, not an AI/ML diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For the purposes of this 510(k), the "ground truth" for proving substantial equivalence lies in the established performance and safety of the predicate devices and compliance with recognized standards. There isn't a "ground truth" in the diagnostic sense (e.g., pathology, outcomes data).
The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set in that context.
How the ground truth for the training set was established: Not applicable.

Summary

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AUG 3 0 2001

510(K) SUMMARY

OPUS 10TM DENTAL DIODE LASER SYSTEM

510(k) Number K ଠୀ / 7 ሬ ¶

Applicant's Name:

OpusDent Ltd. Atid Science Based industrial Park, Hagavish 4 St., Natania south P.O.Box 8737 Natania 42505, Israel Tel.: 972-9-892 3333 Fax: 972-9-892 3300

or:

Contact Person:

Shoshana Friedman, RAC Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 972-9- 7718130 Fax: 972-9-7718131

Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteenth St, NW Washington, DC 20004 Tel: (202) 637-5794 Fax: (202) 637-5910

Date Prepared:

June 2001

Trade Name:

Opus 10TM Dental Diode Laser System

Classification Name:

Laser Instrument, Surgical, Powered

Classification:

FDA has classified laser device as a class II device (product code GEX) and it is reviewed by the General & Plastic Surgery Panel.

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1176974

Predicate Devices:

The Opus 10™ Dental Diode Laser System with the tooth whitening application is substantially equivalent to the Opus 10TM Dental Diode Laser System (OpusDent Ltd.) in terms of, technological characteristics, performance, intended use (generally), indications for use and user interface.

In addition, the Opus 10TM is substantially equivalent to a combination of the Twilite™ Dental Diode Laser system (Biolase Technology, Inc.), to the Aurora™ Diode Laser System (Premier Laser Systems, Inc.) and to the Dentek™ LD 15 Diode laser (Dentek™ Austria GMBH) in terms of intended use, indication for use, technological characteristics and performance.

Performance Standards:

The Opus 10TM Diode Laser complies with:

U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for class IV Laser Products.

In addition, the device complies with the European Medical Directive 93/42/EEC concerning medical devices (Annex II) and with the voluntary standards, EN 60601-1, EN-60825-1, EN-601-2-22, CISPR 11, IEC 61000-4-2/3/4/5, EN55011 and IEC 801-2

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011769 3/4

Intended Use / Indication for Use:

The Indications for Use of the Opus 10™ Dental Diode Laser System include:

Cosmetic Dentistry

Light activation for bleaching materials for teeth whitening ●
Laser-assisted bleaching/whitening of the teeth .

Endodontology

Pulpotomy .
Pulpotomy as an adjunct to root canal therapy .

Periodontology

Sulcular debridement (removal of diseased or inflamed soft tissue in the . periodental pocket)
Oral Soft Tissue Surgery
Biopsy ◆
. Operculectomy
Gingivectomy ●
◆ Gingivoplasty
. Papillectomy
Lesion (tumor) removal .
Leukoplakia .
Treatment of aphthous ulcers .
Fibroma removal .
. Frenectomies and frenotomies
Tissue retraction for impressions
Incising and draining of abscesses
. Exposure of unerupted teeth

Device Description:

The Opus 10TM Dental Diode Laser is designed to perform several medical procedures in the oral soft tissue and to perform laser assisted aesthetic tooth whitening procedures.

A Gallium Aluminum Arsenide (GaAIAs) solid state laser diode provides optical energy to oral soft tissues.

{3}------------------------------------------------

G11 769 4/4

Substantial Equivalence:

There are no unique applications, indications, material or specifications presented herein. Evidence of equivalence has been demonstrated through:

The Opus 10TM intended use and indications for use were previously . cleared by FDA for the predicate devices.
The technical characteristics of the Opus 10™ with the tooth whitening . application are similar to those of the cleared Opus 10TM, Twilite™, Aurora™ and Dentek™
Laser output values of the Opus 10™ are well within previous cleared ◆ values of the predicate dental diode laser systems as described.
The predicate devices and other previous cleared lasers with similar energy . output has a proven safety and effectiveness in the treatment of the claimed indications.
. Safety and performance testing.

Therefore, the Opus 10TM Dental Diode Laser System with the tooth whitening application is substantially equivalent to its predicate devices cited above and raises no new safety and/or effectiveness issues.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three overlapping human profiles facing to the right, with flowing lines beneath them that resemble fabric or water.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2001

OpusDent Ltd. c/o Ms. Shoshana Friedman, RAC Push-Med, Ltd. 117 Ahuzah Street Ra'ananna 43373 Israel

Re: K011769

Trade/Device Name: Opus 10TM Dental Diode Laser System Regulation Number: 878.4810 Regulatory Class: II Product Code: GEX Dated: June 2, 2001 Received: June 7, 2001

Dear Ms. Friedman:

We have reviewed your Section 510(k) 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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Shoshana Friedman, RAC

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Dri imaling of succianter 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 CFF Part 801 and If you desire specific acrice for your ostic devices), please contact the Office of Compliance at additionally 607.10 for m Priro Chagliestions on the promotion and advertising of your device, (201) 594-4639. Radinonaly, and (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or 1011) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours

Susan Wesson, M.D.
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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INDICATIONS FOR USE

510(k) Number (if known): K011769

Device Name: Opus 10™ Dental Diode Laser System

Indications for Use: The Opus 10™ Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening.

The Indications for Use of the Opus 10™ Dental Diode Laser System include:

Cosmetic Dentistry

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

Endodontology

· Pulpotomy
· Pulpotomy as an adjunct to root canal therapy

Periodontology

· Sulcular debridement (removal of diseased or inflamed soft tissue in the periodental pocket)

Oral Soft Tissue Surgery

· Biopsy
· Operculectomy
Gingivectomy .
· Gingivoplasty
Papillectomy .
· Lesion (tumor) removal
· Leukoplakia
· Treatment of aphthous ulcers
· Fibroma removal
Frenectomies and frenotomies
Tissue retraction for impressions
Incising and draining of abscesses
Exposure of unerupted teeth

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

510(k) Number K011764

Prescription Use
(Per 21 CFR 801. 109)

SvL

(Division Sign Off) Use
At the Counter Use

Division of General, Restorative and Neurological Devices

10-8

510(k) Number -

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.