. Removing supra and subgingival calculus deposits and stains from the teeth
Periodontal pocket lavage with simultaneous ultrasonic tip movement .
Scaling and root planing .
. Releasing crowns, bridges, inlays and posts as well as condensing gutta percha
. Plugging for amalgam condensation
Amalgam burnishing ●
. Preparing, cleaning, and irrigating root canals
. Preparing approximal cavities
Cementing inlays and onlays .
. Retrograde preparation of root canals

Device Description

The miniMaster is an ultrasonic scaler consisting of a main chassis containing an external electric power supply, controls and displays, ultrasonic generator, and a bottle-fed irrigation system. A 2-step footswitch is connected to the main chassis by a footswitch cord. A handpiece is connected to the main chassis by a handpiece cord, with irrigant flow control located on the cord itself. Instruments designed for specific dental procedures are attached to the distal end of the handpiece.
Two versions of the miniMaster will be commercially distributed in the US, one with and the other without the capability for dry work.

AI/ML Overview

This document, K050710, is a 510(k) premarket notification for a medical device called the "miniMaster Ultrasonic Scaler." It seeks to demonstrate substantial equivalence to a legally marketed predicate device, the EMS Kermit (K992504).

Based on the provided text, the acceptance criteria and study information are as follows:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state quantitative acceptance criteria or a specific table with reported performance metrics in the format typically seen for AI/ML device studies (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, EMS Kermit. The performance is assessed against the predicate's known and cleared capabilities.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use Equivalence: The miniMaster must have the same intended uses as the predicate device.	"The intended uses of the proposed miniMaster and predicate EMS Kermit are identical." "All of the procedures for which the miniMaster is indicated were cleared for use with the EMS Kermit."
Fundamental Scientific Technology Equivalence: The modifications should not alter the fundamental scientific technology.	"These modifications do not alter the intended use or fundamental scientific technology of the device."
Safety and Effectiveness: The modified device must be safe and effective for its indicated uses.	"The appropriate design verification and design validation activities were conducted to address the potential risks associated with the modified device that were identified in the Risk Analysis. The results confirm that the modified miniMaster is safe and effective for the dental and periodontal cleaning, preparatory, and restorative procedures listed in Section 8."
Functional Performance Equivalence: The modifications should lead to improved functional performance and ease of use without introducing new safety/effectiveness concerns.	"The modifications made to the parent EMS Kermit to produce the proposed miniMaster were implemented to improve the functional performance and ease of use of the ultrasonic scaler." "The similarities in intended use, technical specifications, and functional performance between the miniMaster and the parent EMS Kermit lead to a conclusion of substantial equivalence between the proposed and parent devices."

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

The document does not describe a test set or data provenance in the context of an AI/ML algorithm evaluation. This is a traditional medical device submission, not an AI/ML device submission. The "study" here refers to Design Verification and Design Validation activities.

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

This information is not applicable/not provided as this submission is not for an AI/ML device requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable/not provided as this submission is not for an AI/ML device requiring adjudication of a test set.

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:

This information is not applicable/not provided. This is not an AI-assisted device.

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

This information is not applicable/not provided. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Given this is a physical medical device (ultrasonic scaler), the "ground truth" for its performance would implicitly be:

Clinical Efficacy: Whether the device effectively performs the stated dental procedures (removing calculus, scaling, root planing, etc.) as demonstrated through design validation. This is likely assessed by direct observation, measurement, and comparison to established best practices and the predicate device's performance.
Safety: Absence of adverse events or undue risks, assessed through risk analysis and testing.

The document refers to "design verification and design validation activities" as the basis for confirming safety and effectiveness, but it doesn't detail the specific methodology or "ground truth" sources in the way an AI/ML submission would.

8. The sample size for the training set:

This information is not applicable/not provided. This is not an AI/ML device and therefore does not have a "training set."

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

This information is not applicable/not provided. This is not an AI/ML device.

Summary

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MAR 3 0 2005

K050710

Special 510(k) Summary For miniMaster Ultrasonic Scaler

1. SPONSOR

E.M.S. Electro Medical Systems SA Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland

Contact Person: Suzanne Fassio-Hardy Telephone: 022 994 47 00

Date Prepared March 17, 2005

2. DEVICE NAME

Proprietary Name:	miniMaster
Common/Usual Name:	Ultrasonic Scaler
Classification Name:	Ultrasonic Scaler

3. PREDICATE DEVICES

EMS Kermit (K992504)

ব' INTENDED USE

Removing supra and subgingival calculus deposits and stains from the teeth .
Periodontal pocket lavage with simultaneous ultrasonic tip movement .
. Scaling and root planing
Releasing crowns, bridges, inlays and posts as well as condensing gutta percha .
Plugging for amalgam condensation
. Amalgam burnishing
Preparing, cleaning, and irrigating root canals .

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. Preparing approximal cavities
Cementing inlays and onlays .
Retrograde preparation of root canals .

ನ್ DEVICE DESCRIPTION

Two versions of the miniMaster will be commercially distributed in the US, one with and the other without the capability for dry work.

6. BASIS FOR SUBSTANTIAL EQUIVALENCE

The modifications made to the parent EMS Kermit to produce the proposed miniMaster were implemented to improve the functional performance and ease of use of the ultrasonic scaler. These modifications do not alter the intended use or fundamental scientific technology of the device.

The intended uses of the proposed miniMaster and predicate EMS Kermit are identical. Both the proposed and parent devices are ultrasonic scalers intended for use in dental and periodontal cleaning, preparatory, and restorative procedures. All of the procedures for which the miniMaster is indicated were cleared for use with the EMS Kermit.

The modifications made to the parent EMS Kermit to produce the proposed miniMaster include the following:

Conversion of internal to external electrical power supply .
. Cosmetic changes to the C-51 ultrasonic generator

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Change from external water supply to bottle irrigation with a peristaltic . pump
Compatibility with Universal Piezon Handpiece .
. Addition of newly designed instruments
. Movement of irrigant flow control to handpiece cord
Minor design changes including reorientation of pump in housing and . addition of a handpiece cord disconnect on the housing

The appropriate design verification and design validation activities were conducted to address the potential risks associated with the modified device that were identified in the Risk Analysis. The results confirm that the modified miniMaster is safe and effective for the dental and periodontal cleaning, preparatory, and restorative procedures listed in Section 8.

The similarities in intended use, technical specifications, and functional performance between the miniMaster and the parent EMS Kermit lead to a conclusion of substantial equivalence between the proposed and parent devices.

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of a human face.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2005

E.M.S. Electro Medical Systems SA C/O Cynthia J. M. Nolte, PhD., RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K050710

Trade/Device Name: MiniMaster Ultrasonic Scaler Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: March 17, 2005 Received: March 21, 2005

Dear Dr. Nolte:

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.

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Page 2 -- Cynthia J. M. Nolte, PhD., RAC

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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Chiu S. Lin, Ph.D.

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: miniMaster Ultrasonic Scaler

Indications for Use:

The miniMaster is an ultrasonic scaler that is intended for the following:

. Removing supra and subgingival calculus deposits and stains from the teeth
Periodontal pocket lavage with simultaneous ultrasonic tip movement .
Scaling and root planing .
. Releasing crowns, bridges, inlays and posts as well as condensing gutta percha
. Plugging for amalgam condensation
Amalgam burnishing ●
. Preparing, cleaning, and irrigating root canals
. Preparing approximal cavities
Cementing inlays and onlays .
. Retrograde preparation of root canals

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ken Mulvey for MSP

sion Sign-Off) ision of Anesthesiology, General Hospital. Sation Control, Dental Devices

Number: K 05671C

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.