The PulseMaster® 1000 ST Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is indicated for use in the following procedures:

lesion (tumor) removal
biopsies
fibroma removal
frenectomies and frenotomies
gingivoplasties
gingivectomies
leukoplakia
operculectomies
oral papillectomies
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.

Device Description

The PulseMaster® 1000 ST Dental Laser System is a portable diode laser system intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is software-controlled and utilizes high brightness diode laser technology to provide similar performance characteristics to Nd:YAG lasers.

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and study for the PulseMaster® 1000 ST Dental Laser System:

This 510(k) pertains to a medical device (a dental laser system) and not an AI/ML device. Therefore, many of the requested fields (such as expert adjudication, MRMC studies, standalone algorithm performance, and training set details) are not applicable as they are specific to AI/ML device evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner as might be seen for a new AI/ML device. Instead, the performance is demonstrated by showing substantial equivalence to a predicate device through comparative testing. The criteria for acceptance are implicitly that the new device performs "the same or slightly better than" the predicate, without detrimental effects.

Acceptance Criteria (Implicit)	Reported Device Performance
Performance similar to Nd:YAG lasers, specifically PulseMaster® 1000 Nd:YAG System.	The in vitro study compared the diode laser system (with identical output parameters to PulseMaster® 1000 ST) to the PulseMaster® 1000 Nd:YAG System.
Similar/better performance regarding: - Width of tissue removed - Depth of tissue removed - Lateral thermal coagulation - Deep thermal coagulation - Temperature rise in underlying tissue	Comparison showed that the performance of the diode laser system was "the same or slightly better than" that of the Nd:YAG system regarding: - Width and depth of tissue removed - Lateral and deep thermal coagulation - Temperature rise in underlying tissue.
No detrimental effects due to temperature or coagulation during typical clinical usage for oral soft tissue applications.	The study concluded: "No detrimental effects due to temperature or coagulation would be expected for either system during typical clinical usage for oral soft tissue applications."
Conformance to relevant electrical safety standards.	"Conformance to all relevant requirements of the IEC 601 series of electrical standards."
Software operates as intended.	"Software verification and validation" conducted.

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

Sample Size: Not explicitly stated (e.g., number of tissue samples, trials). The study is described as an "in vitro study."
Data Provenance: In vitro study, comparing the device to a predicate. The specific country of origin or whether it was retrospective/prospective in a clinical sense is not applicable or provided for an in vitro comparison of physical properties.

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

N/A. This is a hardware device assessment, not an AI/ML diagnostic or prognostic tool requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

N/A. Not an AI/ML diagnostic or prognostic tool.

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

N/A. This is not an AI-assisted device.

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

N/A. This is a standalone hardware device, but the concept of "standalone algorithm" doesn't apply.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance was established through direct physical measurement of tissue effects (width/depth of tissue removed, thermal coagulation, temperature rise) in an in vitro setting, against the performance of a known predicate device.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device that undergoes "training."

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

N/A. This is not an AI/ML device that undergoes "training."

Summary

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K972325

SEP 1 9 1997

510(k) Summary

for

PulseMaster® 1000 ST Dental Laser System

SPONSOR INFORMATION 1.

American Dental Technologies, Inc. 28411 Northwestern Highway Southfield, MI 48034

Mr. John G. Sulewski Contact: 248-353-5300 Telephone:

Date Prepared: June 20, 1997

2. DEVICE NAME

Proprietary Name:	PulseMaster® 1000 ST Dental Laser System
Common/Usual Name:	Dental Laser System
Classification Name:	Laser Surgical Instrument
Classification Status:	Class II

PREDICATE DEVICES 3.

PulseMaster® 1000 Dental Laser System . American Dental Technologies, Inc. K922901
Aurora™ Diode Laser System . Premier Laser Systems, Inc. K954316

DEVICE DESCRIPTION AND INTENDED USE 4.

The PulseMaster® 1000 ST Dental Laser System is a portable diode laser system intended for ablating, incising, excising, and coagulating intraoral soft tissue

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(including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is software-controlled and utilizes high brightness diode laser technology to provide similar performance characteristics to Nd:YAG lasers.

TECHNOLOGICAL CHARACTERISTICS 5.

The PulseMaster® 1000 ST Dental Laser System is similar in design, function, and intended use to the predicate surgical dental laser systems identified above. The Aurora System is also a diode laser which operates in a continuous or pulsed (gated) mode with similar wavelength range to the PulseMaster® 1000 ST. All three devices are software-controlled, utilize the same type of generic fiber optic delivery system, and have similar performance characteristics with respect to tissue effects.

6. DEVICE TESTING

Testing conducted on the PulseMaster® 1000 ST Dental Laser System includes software verification and validation, and conformance to all relevant requirements of the IEC 601 series of electrical standards.

An in vitro study compared the performance of the PulseMaster® 1000 Nd: YAG System to a diode laser system with output parameters identical to those of the PulseMaster® 1000 ST System. Comparison of width and depth of tissue removed, lateral and deep thermal coagulation, and temperature rise in underlying tissue showed that the performance of the diode laser system was the same or slightly better than that of the Nd: YAG system. No detrimental effects due to temperature or coagulation would be expected for either system during typical clinical usage for oral soft tissue applications.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized abstract symbol resembling an eagle or bird in flight. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. John G. Sulewski .Product Manager American Dental Technologies 28411 Northwestern Highway Southfield, Michigan 48034

SEP 1 9 1997

Re: K972325

Trade Name: PulseMaster® 1000 ST Dental Laser System Regulatory Class: II Product Code: GEX Dated: June 20, 1997 Received: June 23, 1997

Dear Mr. Sulewski:

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 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 - Mr. John G. Sulewski

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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K 972321

PulseMaster® 1000 ST Dental Laser System Device Name: _

Indications For Use:

lesion (tumor) removal ●
biopsies ●
fibroma removal ●
frenectomies and frenotomies ●
gingivoplasties
gingivectomies ◆
leukoplakia .
. operculectomies
. oral papillectomies
. 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices Kq 72325
510(k) Number

Prescription Use _
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _

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.