The proposed Sirona ultrasonic scalers consist of the ultrasonic handpiece, instrument tips, and control unit, which is part of the Sirona C8+ Dental Operative Unit. The Ultrasonic Scalers are electrically operated scalers driven by a piezo oscillator at 25 to 32 kHz. The piezo oscillator is located in the handpiece and the control/generator unit is located in the C8+ Dental Operative Unit. Both devices include a lamp located in the hose and a spray water controller. A number of optional tips are supplied with the Sirona ultrasonic scalers.

AI/ML Overview

The provided 510(k) summary for the Siroson L and Sirosonic L Ultrasonic Scalers does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the way a clinical performance study would for an AI/ML device.

This document describes a traditional medical device (ultrasonic scaler) and focuses on demonstrating substantial equivalence to a predicate device (EMS Piezon Master 600) rather than a performance study with acceptance criteria and reported metrics in the context of AI/ML.

Here's an analysis based on the provided text, structured to address your points, with explanations of why certain information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Explicitly Stated for clinical performance metrics.	Not Applicable (N/A) for clinical performance metrics as this is not a study assessing diagnostic accuracy or similar.
For substantial equivalence, the criteria are based on comparison of:	The device's overall design, intended use, and technical features are similar to the predicate device.
* Intended Use	* Identical intended uses are stated.
* Principles of Operation	* Similar principles of operation (piezo oscillator, ultrasonic power adjustment, irrigation).
* Overall Design	* Overall design is similar, including handpiece, generator, control unit, and tips.
* Technical Features (e.g., ultrasonic power, irrigation control, operating modes)	* Both devices operate at 25-32 kHz (predicate is not explicitly stated in summary for frequency but implied to be similar). Both have adjustable power, multiple operating modes, and irrigation options. Specific quantitative performance values (e.g., power output, vibration amplitude) are not provided in this summary but would have been part of design verification.
Electrical Safety	Confirmed to meet appropriate standards.
Electromagnetic Compatibility (EMC)	Confirmed to meet appropriate standards.

Explanation: In a 510(k) submission for a non-AI device like this, "acceptance criteria" are generally tied to demonstrating substantial equivalence to a legally marketed predicate device, adherence to recognized standards (e.g., for electrical safety, EMC), and verification/validation activities that address identified risks. There isn't a "performance study" in the sense of a clinical trial measuring diagnostic accuracy or treatment efficacy against a specific numerical threshold for this type of device and submission.

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

Not applicable. This device is an ultrasonic scaler, not a diagnostic or AI device that would typically use a "test set" of data or patient cases for performance evaluation. The "testing" referred to is design verification (electrical safety, EMC), not a study on a data sample.

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

Not applicable. Refer to point 2. Ground truth in this context would relate to direct assessment of the device's physical function and safety standards rather than expert-established clinical interpretations on a dataset.

4. Adjudication Method for the Test Set

Not applicable. Refer to point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for AI/ML diagnostic tools where human readers potentially improve with AI assistance. This is a traditional dental instrument.

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

No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of device's safety and effectiveness relies on:

Engineering specifications and standards: Confirming the device meets its design specifications (e.g., frequency output, power levels, safety features) and relevant national/international standards for electrical safety and electromagnetic compatibility (e.g., IEC 60601-1, IEC 60601-1-2).
Comparison to predicate device: The predicate device (EMS Piezon Master 600) serves as a benchmark for established safety and effectiveness.
Risk analysis: Ensuring all identified potential risks are mitigated through design and testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. This is not an AI/ML device, so there is no training set or ground truth in that context.

Summary

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K033640

DEC 1 2 2003

510(k): Device Modification 510(k) Summary

for

Siroson L and Sirosonic L Ultrasonic Scalers

SPONSOR 1.

Sirona Dental Systems GmbH Farbrikstrasse 31 64625 Bensheim Germany

Contact Person: Fritz Kolle Regulatory Manager

Date Prepared: November 18, 2003

2. Device Name

Proprietary Name:	Siroson and Sirosonic L Ultrasonic Scalers
Common/Usual Name:	Ultrasonic Scaler
Classification Name:	Ultrasonic Scaler

3. Predicate Devices

EMS Piezon Master 600 (K022328)

4. INTENDED USE

The Sirona Sirosonic L and Siroson L are an ultrasonic scalers intended for use in the following dental and periodontal applications:

. Calculus removal (supragingival and subgingival)
. Retrograde root treatment
. Endodontics
. Insertion of inlays
. Micropreparation-(cavity preparation)
. Periodontology

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DEVICE DESCRIPTION ನ.

BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The overall design of the Sirona Ultrasonic Scalers is similar to the design of the Piezon® Master 600. Both 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 Piezon 600 scaler units, the ultrasonic power can be adjusted via a rotary knob on the control unit and delivery of the ultrasonic energy is via a foot control.

The Sirona Scalers and the Piezon® Master 600 allow the operator to select among different operating modes. These modes have different ultrasonic power ranges to assist the operator in maintaining the ultrasonic power within an appropriate range for specific applications.

Both systems allow for irrigation using a bottled water source or an external water source. Irrigation is controlled from the handpiece using a control ring for the Sirona Scalers and a flow regulator for the Piezon® Master 600. Irrigation flow for the Sirona Scalers can also be controlled using a rotary knob on the C8+ dentist's element.

Based on the comparison of intended use and technical features, Sirona Dental Systems believes that the Siroson L and the Sirosonic L are substantially equivalent to the Piezon® Master 600. 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.

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7. PERFORMANCE TESTING

The appropriate design verification and design validation activities were conducted to address the potential risks identified in the Hazard Analysis. These activities included electrical safety testing and electromagnetic compatibility testing. The results confirm that the Siroson L and the Sirosonic L are safe and effective for their intended uses.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2003

Sirona Dental Systems GmbH C/O Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K033640

Trade/Device Name: Siroson L and Sirosonic L Ultrasonic Scalers Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: November 18, 2003 Received: November 20, 2003

Dear Ms. McNamara-Cullinane:

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 ndicetions 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, certo 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. Trounday, controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulterstion.

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 yan 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 - Ms. Mary McNamara-Cullinane

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 (301) 594-4613. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

CluLs

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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K033640 510(k) Number (if known):

Siroson L and the Sirosonic L Ultrasonic Scalers Device Name:

Indications for Use:

The Sirona Dental Systems Siroson L and the Sirosonic L are ultrasonic scalers intended for use in the following dental and periodontal applications:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Swser Rurr

ision Sign-C ign-Off)
Anesthesiology, General Hospital, on Control, Dental

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use ___________

(Optional Format 1-2-96)

November 18, 2003

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.