The EMS Surface Mount Scaler is an ultrasonic scaler and is intended for the removal of supra and subgingival calculus deposits and stains from the teeth; periodontal pocket lavage with simultaneous ultrasonic tip movement; and scaling and root planing.

Device Description

The EMS Surface Mount Scaler consists of a control unit housing containing the ultrasonic generator, a dental handpiece, scaler instrument, and torque wrench. The Scaler is designed to operate in conjunction with the office dental unit. The control unit housing is mounted under the control head of the dental unit and is connected to the water supply, hanger air supply, pneumatic foot switch, and electrical supply of the dental unit. The Scaler ultrasonic power and water flow are simultaneously activated by pressing the dental unit foot switch. Power output and water flow can be adjusted using the knobs on the front of the Scaler. The Scaler handpiece is designed to be placed in the dental unit's handpiece hanger when not in use.

AI/ML Overview

The provided 510(k) summary for the EMS Surface Mount Scaler does not contain specific acceptance criteria or a detailed study proving the device meets them. This type of regulatory submission often focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive performance studies with predefined acceptance criteria as would be expected for novel devices or AI/software as a medical device (SaMD).

However, I can extract information related to the device and its intended use, and then explain why the requested study-related details are not present in this document format.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the document.
Reported Device Performance: Not explicitly stated in terms of quantitative metrics or a performance study. The document asserts that the device is "substantially equivalent" to a predicate device, implying similar performance.

Why this table cannot be fully completed from the provided text:
The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (EMS miniPiezon Ultrasonic Scaler, K953026). For devices like ultrasonic scalers, substantial equivalence is often established by demonstrating similar technological characteristics, intended use, and safety/effectiveness profiles to a predicate device, rather than through a new, extensive clinical performance study with predefined acceptance criteria. Testing for such devices typically involves verifying basic functionality, electrical safety, biocompatibility, and sterilization, which are not detailed in this public summary.

Regarding the other requested information, it is not present in this 510(k) summary because the nature of this submission (510(k) for an ultrasonic scaler) does not typically require such detailed clinical study information as would be seen for complex diagnostic devices or AI/SaMD.

Here's a breakdown of why each point is not addressed:

2. Sample sized used for the test set and the data provenance: Not applicable. No "test set" in the context of a performance study is described. The demonstration of equivalence relies on comparing the device's design and intended use to the predicate.
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" or expert review process is described as part of a performance study.
4. Adjudication method for the test set: Not applicable. No test set 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. This is an ultrasonic scaler, not an AI/diagnostic imaging device that would involve human readers or AI assistance for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical ultrasonic scaler, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth for a performance study is described.
8. The sample size for the training set: Not applicable. The device does not involve machine learning or AI with a "training set."
9. How the ground truth for the training set was established: Not applicable. The device does not involve machine learning or AI.

Summary of what is provided:

Device Name: EMS Surface Mount Scaler
Intended Use: Removal of supra and subgingival calculus deposits and stains from the teeth; periodontal pocket lavage with simultaneous ultrasonic tip movement; and scaling and root planing.
Predicate Device: EMS miniPiezon Ultrasonic Scaler (K953026)
Technological Characteristics Comparison: The document states "The Surface Mount Scaler is substantially equivalent to the EMS miniPiezon ultrasonic scaler. Both devices are intended to be used for the removal of calculus deposits and stains from the teeth. The devices use the same ultrasonic generator and handpiece. The main difference between the devices is that the miniPiezon is a stand-alone ultrasonic scaler while the Surface Mount Scaler works in conjunction with the office dental unit. Minor differences in the user interface, and in the power, air, and water supplies, do not raise new questions of safety and effectiveness, leading to a conclusion of substantial equivalence." This comparison serves as the basis for establishing that the device meets safety and effectiveness expectations, drawing upon the known performance of the predicate device.

Summary

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K99,1874

510(k) Summary for EMS Surface Mount Scaler

1. SPONSOR

EMS SA Ch. de la Vuarpilliere 31 CH - 1260 Nyon Switzerland

Suzanne Fassio Contact Person: 022 994 47 00 Telephone:

June 1, 1999 Date Prepared:

2. DEVICE NAME

Proprietary Name: Common/Usual Name: Classification Name:

EMS Surface Mount Scaler Ultrasonic Scaler Ultrasonic Scaler

PREDICATE DEVICES 3.

EMS miniPiezon Ultrasonic Scaler K953026

4. INTENDED USE

5. DEVICE DESCRIPTION

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water supply, hanger air supply, pneumatic foot switch, and electrical supply of the dental unit. The Scaler ultrasonic power and water flow are simultaneously activated by pressing the dental unit foot switch. Power output and water flow can be adjusted using the knobs on the front of the Scaler. The Scaler handpiece is designed to be placed in the dental unit's handpiece hanger when not in use.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE Q.

The Surface Mount Scaler is substantially equivalent to the EMS miniPiezon ultrasonic scaler. Both devices are intended to be used for the removal of calculus deposits and stains from the teeth. The devices use the same ultrasonic generator and handpiece. The main difference between the devices is that the miniPiezon is a stand-alone ultrasonic scaler while the Surface Mount Scaler works in conjunction with the office dental unit. Minor differences in the user interface, and in the power, air, and water supplies, do not raise new questions of safety and effectiveness, leading to a conclusion of substantial equivalence.

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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 a stylized eagle with three lines representing its head, body, and tail. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

(EMS SA) Electro Medical Systems c/o Sheila Hemeon-Heyer, Esq., RAC Senior Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

K991874 Re : EMS Surface Mount Scaler Trade Name: Requlatory Class: II Product Code: ELC Dated: June 1, 1999 Received: June 2, 1999

Dear Sheila Hemeon-Heyer, Esq., RAC:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Sheila Hemeon-Heyer, Esq., RAC

this response to your premarket notification Please note: 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.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: EMS Surface Mount Scaler

Indications For Use:

The EMS Surface Mount Scaler is indicated for use in:

Removal of supra and subgingival calculus deposits and stains from the teeth .
Periodontal pocket lavage with simultaneous ultrasonic tip movement .
Scaling and root planing .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	Pamela Scott for Susan Runner
Division of Dental, Infection Control,
and General Hospital Devices	K991874
510(k) Number

Prescription Use ✓(Per 21 CFR 801.109)	OR	Over-The-Counter Use ______
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(Optional Format 1-2-96)

EMS SA 510(k)	6/01/99
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EMS Surface Mount Scaler

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.