The Sirona Dental Systems PerioScan is an ultrasonic scaler that aids in the recognition of calculus and intended for use in the following dental and periodontal applications:

. Aiding in subgingival calculus detection
Calculus removal (subgingival and supragingival) .
Retrograde root treatment .
. Endodontics
Insertion of inlays .
. Micropreparation (cavity preparation)
Periodontology

Device Description

The Sirona PerioScan Ultrasonic Scaler consists of a table-top unit with two detachable irrigant bottles with caps (lids), a footswitch, an ultrasonic handpiece, hoses and connectors, a variety of optional tips for different dental procedures, and a tool for attaching the tips to the handpiece.

The PerioScan unit provides ultrasonic scaler therapy as described in the above indications and detection-aid-function for recognition of subgingival calculus.

The table-top unit houses the operator input and controls for the supply of irrigant, cooling liquid and light for the handpiece. The device is connected to 120V mains power supply, and it may be connected to a mains water supply. The irrigant for the handpiece is drawn from the two internal liquid containers or from the mains water supply. The handpiece is connected to the table-top unit via a hose and can be deposited in the claw. A footswitch with two single foot pedals is used to control the handpiece. The PerioScan handpiece is an electrically operated scaler driven by a piezo ceramics. The handpiece includes an illumination and two signal LEDs and a Spray water controller, all located in the hose.

PerioScan switches between detection and scaling operation mode, if selected, using the footswitch. Detection of subgingival calculus is signaled through an illuminator ring and operator display. Additionally a signal tone may be emitted if desired.

AI/ML Overview

The provided text describes the Sirona Dental Systems PerioScan, an ultrasonic scaler with an added detection-aid function for recognizing subgingival calculus. However, the document does not contain specific acceptance criteria or a study detailing the device's performance against such criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested information points cannot be extracted from this document, as the detailed study methodologies and results are absent.

Here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
*Not specified in
the document.*	*Not specified in
the document.*

The document states: "Clinical studies and testing have been performed that validate detection-aid-function for recognition of subgingival calculus for the proposed PerioScan device." However, it does not provide details about these studies, including specific acceptance criteria or the actual performance metrics achieved.

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

Sample Size for Test Set: Not specified in the document.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the document.

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

Number of Experts: Not specified in the document.
Qualifications of Experts: Not specified in the document.

4. Adjudication method for the test set

Adjudication Method (e.g., 2+1, 3+1, none): Not specified in the document.

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

The document implies that the device "aids in the recognition of calculus." However, it does not describe an MRMC comparative effectiveness study or quantify any effect size of human improvement with the device vs. without it. The focus is on the device's ability to signal the presence of calculus.

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

The device is an "ultrasonic scaler that aids in the recognition of calculus," implying a human-in-the-loop scenario where the device provides a signal to the operator. Therefore, a standalone (algorithm only) performance assessment, without human interpretation of the signal, would not be directly applicable to its stated function. The document does not describe such a standalone study.

7. The type of ground truth used

Type of Ground Truth: Not specified in the document. While "subgingival calculus detection" is the target, the method used to definitively establish the presence or absence of calculus for ground truth generation in the "clinical studies and testing" is not described.

8. The sample size for the training set

Sample Size for Training Set: Not specified in the document. The document mentions "clinical studies and testing," but it does not differentiate between training and test sets, nor does it provide sample sizes for either.

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

How Ground Truth for Training Set was Established: Not specified in the document.

Summary of what is known about the study:

Device: Sirona Dental Systems PerioScan Ultrasonic Scaler with a detection-aid function for subgingival calculus.
Purpose of Study (Implied): To validate the detection-aid function for recognition of subgingival calculus.
Outcome: The clinical studies and testing performed validate this function, leading to a determination of substantial equivalence to a predicate device (Sirona PerioScan Ultrasonic Scaler without the detection-aid function).
Limitations from this document: The document is a 510(k) summary, which generally provides a high-level overview. It does not include the detailed study protocols, acceptance criteria, results, or methodologies that would be found in a full study report.

Summary

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173

K072107

510(k) Summary for Sirona Dental Systems PerioScan

l. SPONSOR

Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany

2 mar 1 1 - 1

Contact Person: Fritz Kolle Telephone: 49 6251 16 32 94

Date Prepared: July 25, 2007

2. DEVICE NAME

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

3. PREDICATE DEVICE

Sirona PerioScan Ultrasonic Scaler (K050354) and SiroSonic L Ultrasonic Scaler (K033640).

4. INTENDED USE

The Sirona Dental Systems PerioScan is an ultrasonic scaler that aids in the recognition of calculus and intended for use in the following dental and periodontal applications:

. Aiding in subgingival calculus detection
Calculus removal (subgingival and supragingival) .
Retrograde root treatment .
. Endodontics
Insertion of inlays .
. Micropreparation (cavity preparation)

Sirona Dental 510(k) Summary Perioscan

July 25, 2007

APPENDIX G . Page 1 of 3

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K072107

Periodontology

5. DEVICE DESCRIPTION

The PerioScan unit provides ultrasonic scaler therapy as described in the above indications and detection-aid-function for recognition of subgingival calculus.

6. BASIS FOR SUBSTANTIAL EQUIVALENCE

The overall design of the Sirona PerioScan Ultrasonic Scaler with detection-aidfunction for recognition of subgingival calculus is similar to the design of the Sirona PerioScan Ultrasonic Scaler (PerioScan Basic) with no detection-aid-function. Both of these devices include a dental handpiece and ultrasonic generator. They all contain software, which controls delivery of the ultrasonic power, and include various tip configurations for the differing dental procedures.

On both the proposed and predicate PerioScan Scaler (PerioScan Basic) units, the ultrasonic power can be adjusted on the control unit and delivery of the ultrasonic energy is via a foot control. Both devices allow the operator to select among different therapy operating modes. These modes have different ultrasonic power ranges to

Sirona Dental 510(k) Summary Perioscan

July 25, 2007

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Image /page/2/Picture/1 description: The image shows a handwritten string of characters, which appears to be a combination of letters and numbers. The string reads "KO72107". The characters are written in a cursive style, with some connecting strokes between them. A horizontal line is drawn beneath the string of characters.

assist the operator in maintaining the ultrasonic power within an appropriate range for specific applications. Both Systems allow for irrigation using two internal containers (small and large) or an external water source. Irrigation flow is controlled by handpiece, operator's panel and footswitch for the Sirona PerioScan with detection-aid-function as well as for the PerioScan with no such function.

The PerioSonic handpiece used with the Sirona PerioScan with detection-aidfunction is the SiroSonic L handpiece with minor alterations for enabling detection capability and signaling.

Clinical studies and testing have been performed that validate detection-aid-function for recognition of subgingival calculus for the proposed PerioScan device.

Based on the comparison of intended use and technical features, Sirona Dental Systems believes that the PerioScan with detection-aid-function for recognition of subgingival calculus is substantially equivalent to the PerioScan with no such function. The proposed and predicate devices have the same general intended use and principles of operation. The overall design of the proposed and predicate devices is similar. The detection function aids the practitioner in recognizing of subgingival calculus who assesses the diagnosis result and the subsequent therapy.

Sirona Dental 510(k) Summary Perioscan

July 25, 2007

APPENDIX G . Page 3 of 3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The text is in all caps and is written in a sans-serif font.

FEB 1 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Fritz Kolle Quality Management/Regulatory Affairs Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim GERMANY

Re: K072107

Trade/Device Name: PerioScan Model D 3496 Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: February 1, 2008 Received: February 4, 2008

Dear Mr. Kolle:

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 - Mr. Kolle

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 (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.

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" (21CFR 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/cdrh/industry/support/index.html.

Sincerely vours.

Suite y. Michien Ows

Chiu Lin, Ph.D. 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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K072107

510(k) Number (if known):

Device Name: __________ PerioScan

Indications for Use:

The Sirona Dental Systems PerioScan Ultrasonic Scaler is an ultrasonic scaler that aids in the recognition of calculus and intended for use in the following dental and periodontal applications:

. Aiding in subgingival calculus detection
. Calculus removal (subgingival and supragingival)
. Retrograde root treatment
. Endodontics
. Insertion of inlays
Micropreparation (cavity preparation) .
. Periodontology

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) OR

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

(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 Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: KD172107

Sirona Dental Systems 510(k) Perioscan

July 25, 2007

Page viii

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.