The SunLase 800P laser device is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The device is indicated for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact, fiber-optic delivery system. The device will be used in the following areas: general and cosmetic dentistry, otolaryngology, oral surgery. The following are the oropharangeal indications for use for which the device will be marketed:

Excisional and incisional biopsies
Excision and vaporization of herpes simplex I and II
Exposure of unerupted teeth
Fibroma removal
Frenectomy and Frenotomy
Gingival troughing for crown impressions
Gingivectomy
Gingivoplasty
Gingival incision and excision
Hemostasis
Implant recovery
Incision and drainage of abscess
Laser Assisted Uvulopaletoplasty (LAUP)
This laser is effective for cutting, ablating, coagulating and removing oropharangeal soft tissue that has been diagnosed as anatomically abnormal or naturally occurring hypertrophic which has been identified and confirmed as being associated with chronic palatal snoring.
Leukoplakia
Operculectomy
Oral Papillectomies
Pulpotomy and Pulpotomy as an adjunct to root canal therapy
Reduction of denture hyperplasia
Reduction of gingival hypertrophy
Reduction of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
Removal of post-surgical granulations
Selective ablation of enamel (First Degree Caries Removal)
Soft tissue crown lengthening
Sulcular debridement or soft tissue curettage (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)
Tissue retraction for impression
Treatment of Apthous ulcers
Vestibuloplasty

Device Description

The laser device produces an invisible treatment beam for surgery and a visible aiming beam. The pulsed Nd:YAG treatment beam is an invisible beam of light (1064 nanometer wavelength); a Helium-Neon (HeNe) laser within the laser head console supplies the red aiming beam. The laser energy is developed inside an optical resonant cavity. A crystal rod of neodymium-doped Yttrium Aluminum Garnet (pulsed Nd:YAG) is placed between two mirrors. The rod is "pumped" by a flashlamp that excites the Neodymium ions in the YAG crystal. Once excited, stimulated emission of photons occurs. Laser energy exits the cavity through a partially transmitting mirror and enters the distal end of the contact fiber-optic cable at the aperture. The laser energy is transmitted though the fiber-optic cable and exits the proximal tip of the fiber. The device is controlled by microprocessor via keyboard access by the operator, which allows various settings for energy levels, pulse widths and repetition rates. Software controls preclude emission of laser energy in any of a number of fault conditions.

AI/ML Overview

The provided text describes a medical device, the SunLase 800P Dental Laser (also marketed as PocketPro or PocketPro S4), and its intended uses. It is a 510(k) premarket notification and primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing a specific study to prove the device meets acceptance criteria.

Therefore, many of the requested elements for describing an acceptance criteria study, such as sample sizes, expert qualifications, adjudication methods, and details about training/test sets, are not explicitly present in the provided document.

However, I can extract information related to the device description, its indications for use (which act as a form of acceptance criteria in regulatory submissions), and the rationale for its approval.

Here's a breakdown of the available information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this 510(k) submission are implicitly defined by the "Indications for Use" and the device's ability to perform these functions substantially equivalently to predicate devices. The "reported device performance" is essentially that it can perform these specified functions.

Acceptance Criteria (Indications for Use)	Reported Device Performance
Intraoral Soft Tissue Dental Surgery: Ability to perform ablating, incising, excising, vaporization, and coagulation of soft tissues.	Device performs these functions using a contact, fiber-optic delivery system.
Specific Oropharyngeal Indications (examples): - Excisional and incisional biopsies - Excision and vaporization of herpes simplex I and II - Exposure of unerupted teeth - Fibroma removal - Frenectomy and Frenotomy - Gingival troughing for crown impressions - Gingivectomy - Gingivoplasty - Gingival incision and excision - Hemostasis - Implant recovery - Incision and drainage of abscess - Laser Assisted Uvulopaletoplasty (LAUP) for cutting, ablating, coagulating and removing anatomically abnormal or naturally occurring hypertrophic oropharyngeal soft tissue associated with chronic palatal snoring. - Leukoplakia - Operculectomy - Oral Papillectomies - Pulpotomy and Pulpotomy as an adjunct to root canal therapy - Reduction of denture hyperplasia - Reduction of gingival hypertrophy - Removal of filling material (gutta percha or resin) as adjunct treatment during root canal therapy - Removal of post-surgical granulations - Selective ablation of enamel (First Degree Caries Removal) - Soft tissue crown lengthening - Sulcular debridement or soft tissue curettage (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) - Tissue retraction for impression - Treatment of Apthous ulcers - Vestibuloplasty	The device is indicated for and effectively used in these procedures, with the rationale that its technology and tissue effects are substantially equivalent to legally marketed predicate devices for these applications.
Safety: Software controls preclude emission of laser energy in a number of fault conditions.	Not explicitly quantified in terms of specific performance metrics, but presented as a design feature for safety.

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

Not applicable/Not provided. The document is a 510(k) notification, which primarily relies on substantial equivalence to predicate devices rather than a de novo clinical study with a detailed test set. The approval is based on the argument that the SunLase 800P is "based on the same technology" and that its operational technology differs "only by source of emission, pulse rate, and wavelength" from predicate devices. It states, "Tissue effects by predicate Nd. YAG and diode devices exhibit identical physical characteristics." This suggests a reliance on existing knowledge and effects of similar devices, rather than a specific test set of cases.

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

Not applicable/Not provided. As there is no described test set or clinical study to establish ground truth in the traditional sense, information on experts is not part of this document. The "ground truth" for this application is essentially the established clinical utility and safety of the predicate devices.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or clinical study requiring adjudication is described.

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/Not provided. This is a hardware device (laser) and the submission does not involve AI or human "readers."

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

Not applicable/Not provided. This is a physical laser device, not an algorithm. Its operation inherently involves a human operator.

7. The type of ground truth used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices for the specified indications. The applicant argues that the SunLase 800P is substantially equivalent to these predicates due to similar technology, operational characteristics, and identical physical characteristics of tissue effects.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of a "training set" as this is not a machine learning or AI device. The device's design and functionality are based on established laser technology.

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

Not applicable/Not provided. As there is no training set in the context of this device, this question is not relevant to the provided text.

Summary

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011960 '/

Lares Research Applicant: 295 Lockheed Ave. Chico, CA 95973 Contact Person: Thomas H. Louisell Tel: (530) 345-1767 x262 Fax: (530) 345-1870 Date Prepared: 17 May 2001 PocketPro or PocketPro S4 Device Trade Name: Nd:YAG Pulsed Laser Common Name: Instrument. Surgical, Powered, Laser (79-GEX) Classification Name: Legally Marketed American Dental Technologies - PulseMaster™ Predicate Devices: American Dental Technologies - DioLase ST™ BioLase Technology, Inc. - TwiLite™ CeramOptec - Ceralas® D15 Dentek Laser Systems - LD-15 ™ OpusDent, Ltd. - Opus 10TM Premier Laser Systems - Aurora ™ Xintec Corporation - Dentica TM The laser device produces an invisible treatment beam for surgery and a Device Description: visible aiming beam. The pulsed Nd:YAG treatment beam is an invisible beam of light (1064 nanometer wavelength); a Helium-Neon (HeNe) laser within the laser head console supplies the red aiming beam. The laser energy is developed inside an optical resonant cavity. A crystal rod of neodymium-doped Yttrium Aluminum Garnet (pulsed Nd:YAG) is placed between two mirrors. The rod is "pumped" by a flashlamp that excites the Neodymium ions in the YAG crystal. Once excited, stimulated emission of photons occurs. Laser energy exits the cavity through a partially transmitting mirror and enters the distal end of the contact fiber-optic cable at the aperture. The laser energy is transmitted though the fiber-optic cable and exits the proximal tip of the fiber. The device is controlled by microprocessor via keyboard access by the operator, which allows various settings for energy levels, pulse widths and repetition rates. Software controls preclude emission of laser energy in any of a number of fault conditions. Summary Rationale: The SunLase 800P is a free running Nd:YAG laser based on the same technology as the predicate Nd:YAG lasers listed above. In addition, the predicate diode laser devices listed above operate clinically in substantially equivalent fashion; their operational technology differs only by source of emission, pulse rate, and wavelength. Tissue effects by predicate Nd. YAG and diode devices exhibit identical physical characteristics. As such, the

indications for use and intended uses are the same. This consolidation of

clinical applications presents no new safety issues.

510(k) Summary of Safety and Effectiveness

SunLase 800P Dental Laser

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11960 i/2

Intended Uses:

The following are the oropharangeal indications for use for which the device will be marketed:

· Excisional and incisional biopsies
· Excision and vaporization of herpes simplex I and II
· Exposure of unerupted teeth
Fibroma removal
· Frenectomy and Frenotomy
· Gingival troughing for crown impressions
· Gingivectomy
· Gingivoplasty
· Gingival incision and excision
· Hemostasis
· Implant recovery
· Incision and drainage of abscess
· Laser Assisted Uvulopaletoplasty (LAUP)
- This laser is effective for cutting, ablating, coagulating and removing oropharangeal soft tissue that has been diagnosed as anatomically abnormal or naturally occurring hypertrophic which has been identified and confirmed as being associated with chronic palatal snoring.
· Leukoplakia
· Operculectomy
· Oral Papillectomies
· Pulpotomy and Pulpotomy as an adjunct to root canal therapy
· Reduction of denture hyperplasia
· Reduction of gingival hypertrophy
· Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
· Removal of post-surgical granulations
· Selective ablation of enamel (First Degree Caries Removal)
· Soft tissue crown lengthening
· Sulcular debridement or soft tissue curettage (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)
· Tissue retraction for impression
Treatment of Apthous ulcers
· Vestibuloplasty

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's seal, which includes a stylized caduceus symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2001

Mr. Thomas H. Louisell Director, Regulatory Affairs and Quality Systems Lares Research, Inc. 295 Lockheed Avenue Chico, California 95973

Re: K011960

Roll 200 PocketPro S4® Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 28, 2001 Received: October 5, 2001

Dear Mr. Louisell:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surve in the encreativent of the enactment date of the Medical Device Amendments, or to conninered prior to ria) 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de nees that have been require approval of a premarket approval application (PMA). and Oosmeter For ( 100) kes the device, subject to the general controls provisions of the Act. The r ou may, arorely mails 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 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 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 or any 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 – Mr. Thomas H. Louisell

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter whil anow you to begin manisting of substantial equivalence of your device to a legally premarket notification. The PDF micing of casion 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 II you desire specific au vice for your avitro diagnostic devices), please contact the Office of additionally 21 CFR Fall 607.10 for m. vial v. Secondition on the promotion and advertising of Compliance at (301) 594 1057. Themsel Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation citined, "Misormation on your responsibilities under the Act may be obtained from the Other general information on your respentional 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,

Hyk Qurdu

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: K011960

DEVICE NAME: SunLase 800P Laser System (to be sold as "PocketPro®" or "PocketPro S4®"

INDICATIONS FOR USE:

The SunLase 800P laser device is to provide the ability to perform intraoral soft tissue dental, The SunLase oool Tason downer is to pro surgery. The device is indicated for ablating, incising, general, oral maxilio-raolar and coatine soft tissues using a contact, fiber-optic delivery system. excising, vaponzation and ougalation oreas: general and cosmetic dentistry, otolaryngology, The device will be used in the following are the oropharangeal indications for use for which the device will be marketed:

· Excisional and incisional biopsies
· Excision and vaporization of herpes simplex I and II
· Exposure of unerupted teeth
Fibroma removal
· Frenectomy and Frenotomy
· Gingival troughing for crown impressions
· Gingivectomy
· Gingivoplasty
· Gingival incision and excision
· Hemostasis
· Implant recovery
· Incision and drainage of abscess
· Laser Assisted Uvulopaletoplasty (LAUP)
- This laser is effective for cutting, ablating, coagulating and removing This labor to off tissue that has been diagnosed as anatomically abnormal or oropharangour our the which has been identified and confirmed as being associated with chronic palatal snoring.
Leukoplakia
· Operculectomy
· Oral Papillectomies
Pulpotomy and Pulpotomy as an adjunct to root canal therapy
· Reduction of denture hyperplasia
· Reduction of gingival hypertrophy
· Reduction of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
Removal of post-surgical granulations
· Selective ablation of enamel (First Degree Caries Removal)
· Soft tissue crown lengthening
Sulcular debridement or soft tissue curettage (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)
· Tissue retraction for impression
· Treatment of Apthous ulcers
· Vestibuloplasty

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Page_2 of_2

Signature :

Thomas H. Fricolt

Name : Title : Date :

Thomas H. Louisell Director - Regulatory Affairs & Quality Systems 17 May 2001

Concurrence of CDRH, Office of Device Evaluation (ODE)

C Prescription Use (Per 21 CFR 801.109)

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

Styph Charly

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

510(k) Number K011960

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.