The Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended for use in the medical specialty of dental surgery.

The Curative980 Diode Lasers (and the delivery accessories that are used with them to deliver laser energy) is indicated for use in a variety of applications requiring incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue in the medical specialty of dental surgery.

The Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended to deliver laser energy for incision, ablation, vaporization, coagulation and hemostasis of soft tissue in the medical specialty of dental surgery as follows:

Dental Surgery

Indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissue (intraoral and extraoral) including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications:

Biopsy
Excisional and incisional biopsies
Excision of lesions
Exposure of unerupted/partially erupted teeth
Fibroma removal
Frenectomy
Frenotomy
Gingival troughing for crown impressions
Gingival troughing
Gingivectomy
Gingivoplasty
Gingival incision and excision
Hemostasis and coagulation
Hemostasis of donor site
Implant recovery
Removal of granulation tissue
Laser assisted flap surgery
Debridement of diseased epithelial lining
Treatment of aphthous ulcers
Sulcular debridement (removal of diseased or inflamed soft-tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
Laser soft tissue curettage
Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
Operculectomy
Incision and drainage of abscess
Oral papillectomies; papillectomy
Removal of hyperplastic tissues
Pulpotomy
Pulpotomy as an adjunct to root canal therapy
Reduction of gingival hypertrophy
Reduction of bacterial level (decontamination) and inflammation
Soft tissue crown lengthening; crown lengthening
Tissue retraction for impressions
Leukoplakia
Vestibuloplasty
Light activation of bleaching materials for teeth whitening.
Laser-assisted bleaching/whitening for teeth

Device Description

The Curative980 Diode Lasers are comprised of the following main components:

Main console containing the major electrical components, including:
Control Touch-Screen Display Panel including touch controls;
980 nm treatment laser (aluminum gallium arsenide (AlGaAs) solid state laser diode);
650 nm aiming beam diode laser;
Delivery device fiber-optic connector port;
Emergency stop switch;
Remote interlock connector (External door interlock connector);
Connector ports for the footswitch and power cord;
Handpiece holder (attaches to the top of the laser system console);
Fiber Spool (secures and organizes the optical fiber) attaches to the side of the main console;
Footswitch:
Medical grade power cord;
Delivery Devices:
Optical Fibers - Reusable, cleanable, sterilizable optical fibers;
Handpieces -Reusable, cleanable, sterilizable handpieces;
Handpiece Tips - Disposable single-use tips;
Accessories:
Safety Glasses
Tools:
Optical Fiber Striper;
Optical Fiber Cleaver.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (OroScience Curative980 Diode Lasers). This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you've described for, say, an AI diagnostic tool.

Therefore, the information you're asking for regarding acceptance criteria, performance tables, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable to this type of regulatory submission.

The core of a 510(k) summary for a device like this laser is to show that it has the same or similar:

Indications for Use
Device Operation
Overall Technical and Functional Specifications

And that any differences do not raise new questions of safety or effectiveness. The "study" here is essentially a comparison to predicate devices, not a clinical trial against specific performance metrics with a ground truth established by experts.

Here's a breakdown of why this information isn't present in the provided text, using the structure of your request:

Table of acceptance criteria and the reported device performance:
- N/A. This document doesn't define specific numerical acceptance criteria for performance; rather, it asserts substantial equivalence to existing predicate devices. The "performance" is implicitly deemed equivalent if the device functions similarly and has the same indications for use as the predicates.
Sample size used for the test set and the data provenance:
- N/A. There isn't a "test set" in the sense of clinical data evaluating the device's diagnostic or treatment efficacy against a ground truth. The submission relies on engineering and design comparisons.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No ground truth needed to be established by experts for a test set in this kind of submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No test set or expert adjudication was performed as described.
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:
- N/A. This is a laser surgical instrument, not an AI-assisted diagnostic tool. MRMC studies are irrelevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Again, this is a physical medical device (laser), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. No ground truth in this context. The "truth" being established is that the device is substantially equivalent to legally marketed devices.
The sample size for the training set:
- N/A. This device doesn't use machine learning or require a training set.
How the ground truth for the training set was established:
- N/A. No training set exists for this type of device.

In summary, the "study" proving the device meets "acceptance criteria" in a 510(k) context is the demonstration of substantial equivalence to existing predicate devices based on design specifications, intended use, and operational principles, not a clinical trial with performance metrics against a defined ground truth.

Summary

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Section 5 - 510(k) Summary

I. General Information

Submitter:	OroScience, Inc.2275 East Bayshore Road, Suite 106Palo Alto, CA 94303
Contact Person:	Phil HouleVice President R&D, Operations
Summary Preparation Date:	July 2, 2008

II. Names

Device Names:	Curative980 Diode Lasers (and delivery device accessories)
---------------	------------------------------------------------------------

Primary Classification Names: Laser Powered Surgical Instruments (and Accessories)

III. Predicate Devices

Quanta System Diode Medical Laser 808, 940, or 980 nm (K072034) .
Hoya ConBio DioDent MICRO 980 nm (K063384) .
Biolitec Ceralas 980 nm / SmilePro 980 (K050824) .
Laser Dental Innovations LiteSaber™ 2000 (K993942) .
Laser Dental Innovations StarLite 2006 (K052604) .
B&W Tek, Inc. BWF-5 Medical Laser Series (K062363) .

IV. Product Description

The Curative980 Diode Lasers are comprised of the following main components:

Main console containing the major electrical components, including:
- Control Touch-Screen Display Panel including touch controls;
- 980 nm treatment laser (aluminum gallium arsenide (AlGaAs) solid state laser diode);
- 650 nm aiming beam diode laser; A
- Delivery device fiber-optic connector port; A
- A Emergency stop switch;
- Remote interlock connector (External door interlock connector); A
- A Connector ports for the footswitch and power cord;
- Handpiece holder (attaches to the top of the laser system console); A
- Fiber Spool (secures and organizes the optical fiber) attaches to the side of A the main console;
Footswitch: .
Medical grade power cord; .
Delivery Devices: .
- Reusable, cleanable, sterilizable optical fibers; > Optical Fibers -

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A Handpieces -Reusable, cleanable, sterilizable handpieces; A Handpiece Tips - Disposable single-use tips;
. Accessories:
- A Safety Glasses
Tools:
- A Optical Fiber Striper;
- A Optical Fiber Cleaver.

V. Indications for Use

The Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended for use in the medical specialty of dental surgery.

VI. Rationale for Substantial Equivalence

The Curative980 Diode Lasers share the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.

VII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the Curative980 Diode Lasers are substantially equivalent to the predicate devices.

VIII. Conclusion

The Curative980 Diode Lasers were found to be substantially equivalent to the predicate devices.

The Curative980 Diode Lasers share identical indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

OCT 1 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OroScience, Inc. % A Worden Consulting Ms. Anne Worden 3637 Bernal Avenue Pleasanton, California 94566

Re: K082445 Trade/Device Name: OroScience Curative980 Diode Lasers Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use ing eneral and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 9, 2008 Received: October 10, 2008

Dear Ms. Worden:

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

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Page 2 - Ms. Anne Worden

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 100-100.

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 the reporting 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 vours.

Mark N. Millman

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 - Continued

510(k) Number (if known): K08

Device Name: OroScience Curative980 Diode Lasers

Indications for Use:

Dental Surgery

Biopsy ●
Excisional and incisional biopsies .
Excision of lesions ●
Exposure of unerupted/partially erupted teeth .
Fibroma removal .
Frenectomy .
Frenotomy 0
Gingival troughing for crown impressions .
. Gingival troughing
. Gingivectomy
. Gingivoplasty
Gingival incision and excision .
Hemostasis and coagulation .
Hemostasis of donor site �
Implant recovery .
Removal of granulation tissue .
Laser assisted flap surgery .

Prescription Use (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)

Signature

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

510(k) Number	1082445
---------------	---------

Page 1 of 2

017

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Indications for Use Statement - Continued

510(k) Number (if known): K08

Device Name: OroScience Curative980 Diode Lasers

Indications for Use - Continued:

Dental Surgery - Continued

Debridement of diseased epithelial lining ●
Treatment of aphthous ulcers .
Sulcular debridement (removal of diseased or inflamed soft-tissue in the periodontal . pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
Laser soft tissue curettage .
Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa .
. Operculectomy
Incision and drainage of abscess .
Oral papillectomies; papillectomy .
Removal of hyperplastic tissues .
. Pulpotomy
. Pulpotomy as an adjunct to root canal therapy
. Reduction of gingival hypertrophy
Reduction of bacterial level (decontamination) and inflammation .
Soft tissue crown lengthening; crown lengthening .
Tissue retraction for impressions .
Leukoplakia .
Vestibuloplasty .
Light activation of bleaching materials for teeth whitening. .
Laser-assisted bleaching/whitening for teeth .

V Prescription Use (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)

Page 2 of 2

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.