The Sirona Dental Systems T1 / T2 / T3 turbine family consists of air powered, high speed handpieces. The handpieces are reusable, ergonomically shaped and include (T1 and T2 Turbines) a fiber optic light system. The water delivery geometry includes 4 pair of water / air spray nozzles just below the head with one way retraction valves to prevent the ingress of external water or air, when the spray system is shut down. The devices are sterilizable in an autoclave. The turbines are provided in three variants: control, boost and mini.

In addition, the turbines are compatible with the following quick-coupling:

Sirona R coupling
Sirona F coupling
Sirona B coupling
KaVo coupling
W&H coupling
NSK MachLite coupling
NSK QD-J coupling

AI/ML Overview

This document is a 510(k) summary for a dental device, specifically the Sirona Dental Systems T1 / T2 / T3 Turbine family. Due to the nature of the device (a dental handpiece) and the regulatory submission (510(k)), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are discussed in the context of demonstrating substantial equivalence to predicate devices, rather than through formal clinical trials with specific performance metrics such as sensitivity, specificity, or accuracy, which are typical for diagnostic or AI-driven devices.

Here's a breakdown based on the provided text, addressing your questions where applicable and noting where the information is not relevant to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are predominantly compliance with recognized international standards and demonstration of similar technological characteristics and performance to predicate devices. The "reported device performance" is a comparison of these characteristics to the predicate devices.

Acceptance Criteria (Implied by Standards & Predicate Comparison)	Reported Device Performance (Sirona T1 / T2 / T3 Turbine family)	Predicate Device 1 (Nakanishi Ti-Max X)	Predicate Device 2 (Morita Twin Power)
Principle of Operation (Air-driven turbine)	Turbine, Air driven	Turbine, Air driven	Turbine, Air driven
Couplings to Treatment Chair (Compatibility with common couplings)	Sirona, Kavo, NSK, W&H	Sirona, Kavo, NSK, W&H, Bienair	Sirona, Kavo, NSK, W&H, Morita
Speed Range (Comparable to predicates)	250,000 - 400,000 rpm	300,000 - 450,000 rpm	320,000 - 400,000 rpm
Power [W] (Comparable to predicates)	22/23/20 W	16-22 W	18-22 W
Chuck (Push button FG)	Push button FG	Push button FG	Push button FG
Light Intensity [lux] (If applicable, comparable to predicates)	25,000 lux	Data not available	25,000 lux
Intended Use (Matching or equivalent to predicates)	-Preparation of cavities & crowns-Removal of carious material-Removal of fillings-Processing of tooth & restoration surfaces-Reducing hard tooth structure	...removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.	...for use by authorized persons in the practice of the dentistry.
Compliance with ISO Standards (14457, 1797, 9168, 21531)	Complies with ISO 14457, ISO 1797, ISO 9168, ISO 21531	Implicitly compliant for predicates	Implicitly compliant for predicates
Sterilization Process (Validation)	Validation performed	Not explicitly stated for predicates, but implied by class	Not explicitly stated for predicates, but implied by class
Device Effectiveness (Validation)	Validation performed	Not explicitly stated for predicates, but implied by class	Not explicitly stated for predicates, but implied by class
Biocompatibility (Validation)	Validation performed	Not explicitly stated for predicates, but implied by class	Not explicitly stated for predicates, but implied by class
Quick Coupling (Reverse engineering)	Reverse engineering conducted	Not explicitly stated for predicates, but implied by design	Not explicitly stated for predicates, but implied by design

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

This is not applicable to this type of device submission. The submission is for a mechanical dental handpiece, and its performance is evaluated through engineering tests, compliance with standards, and comparison of technical specifications to legally marketed predicate devices, not through a "test set" of patient data or clinical cases.

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

This is not applicable to this type of device submission. There is no concept of a "ground truth" derived from expert consensus for a mechanical dental handpiece in the way it would be for an AI diagnostic device. The ground truth, in a technical sense, would be defined by engineering specifications and material properties, validated through laboratory testing.

4. Adjudication Method for the Test Set

This is not applicable to this type of device submission. There is no "test set" requiring adjudication in the context of a mechanical handpiece's 510(k) submission.

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 is not applicable to this device. It is a traditional mechanical dental handpiece, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study, AI integration, or human reader improvement metric is relevant.

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

This is not applicable. The device is a mechanical dental handpiece; there is no algorithm, AI, or software component that operates in a standalone manner.

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

For this device, the "ground truth" is established through adherence to international standards (ISO 14457, 1797, 9168, 21531), engineering specifications, and validation through laboratory performance testing related to sterilization, device effectiveness, and biocompatibility. There is no patient-specific "ground truth" in the clinical sense mentioned (pathology, outcomes data, expert consensus). The performance is measured against objective, quantifiable physical and sterile conditions.

8. The Sample Size for the Training Set

This is not applicable to this device. There is no "training set" as it is not an AI/ML device.

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

This is not applicable to this device. There is no "training set."

Summary

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510(k) Summary

MAY 3 0 2014

for

Sirona Dental Systems T1 / T2 / T3 Turbine family

with serial no. > 600 000

Sponsor 1

Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany

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

Date Prepared: May 1, 2013

ମଧ Device Name

Proprietary Name: T1 / T2 / T3 Turbine family with serial no. > 600 000

Common/Usual Name: High speed air turbine

Classification Name: Handpiece, air-powered, dental

3 Predicate Devices

Nakanishi Ti-Max X Turbine (K113655) and the Morita Twin Power Turbine (K 043498)

Sirona Dental Systems T1 / T2 / T3 Turbine family with serial no. > 600 000 Traditional 510(k) Summary May 1, 2013

APPENDIX G . Page 1 of 3

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4 Intended Use

The turbines of the T1 / T2 / T3 Turbine family are intended for the

Preparation of cavities and crowns
Removal of carious material
Removal of fillings
Processing of tooth and restoration surfaces
Reducing hard tooth structure

Device Description 4.1

In addition, the turbines are compatible with the following quick-coupling:

Sirona R coupling
Sirona F coupling
Sirona B coupling
KaVo coupling
W&H coupling
NSK MachLite coupling
NSK QD-J coupling

5 Summary of the technological characteristics

The Sirona Dental Systems T1 / T2 / T3 turbine familar in the operating principle, technical data and performance to other high speed dental handpieces currently in the US commercial distribution. Examples of substantially equivalent devices include Nakanishi Ti-Max X Turbine (K113655) and the Morita Twin Power Turbine (K 043498). Below is a comparison of the proposed device to the predicate devices.

Sirona Dental Systems T1 / T2 / T3 Turbine family with serial no. > 600 000 Traditional 510(k) Summary May 1, 2013

APPENDIX G . Page 2 of 3

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	Sirona T1 / T2 / T3turbine family	Nakanishi Ti-Max X(K113655)	Morita Twin Power(K043498)
Principle of operation	TurbineAir driven ¹	TurbineAir driven	TurbineAir driven
Couplings to treatmentchair	Sirona, Kavo, NSK,W&H	Sirona, Kavo, NSK,W&H, Bienair	Sirona, Kavo, NSK,W&H, Morita
Speed range	250000-400000	300000-450000	320000-400000
Power [W]	22/ 23/ 20	16-22	18 -22
Chuck	Push button FG	Push button FG	Push button FG
Light intensity [lux]	25000	Data not available	25000
Intended use	- Preparation ofcavities and crowns- Removal of cariousmaterial- Removal of fillings- Processing of toothand restorationsurfaces- Reducing hard toothstructure	... intended forremoving cariousmaterial, reducinghard tooth structure,cavity preparation,finishing toothpreparations andrestorations andpolishing teeth.	TWIN POWERTUBINE is for use byauthorized persons inthe practice of thedentistry

					Table 1: Comparison of the proposed device to the declared predicate devices.

1 As described in Sec. 11.1 ion page 9 and 10 in the original submission

6 Performance Testing

The Sirona T1 / T2 /T3 turbine family complies with ISO 14457 Dentistry -Handpieces and motors, ISO 1797 Dental Rotary Instruments - Shanks, ISO 9168 Dental Handpieces - Hose Connections, ISO 21531 Dentistry - Graphical symbols for dental instruments, additional performance testing was conducted to validate the sterilization process, device effectiveness and biocompatibility. Reverse engineering of the quick coupling was also conducted.

7 Clinical Testing

Clinical testing has not been performed.

8 Conclusion

Based on a comparison of intended use, indications, principal of operations, features and technical data, the Sirona Dental T1 / T2 / T3 high speed turbine family is substantially equivalent to its Predicate Devices.

Sirona Dental Systems T1 / T2 / T3 Turbine family with serial no. > 600 000 Traditional 510(k) Summary May 1, 2013

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract symbol that resembles a person with outstretched arms. The symbol is made up of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug, Administration 19903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 30, 2014

Sirona Dental Systems GmbH Mr. Fritz Kolle Regulatory Manager Fabrikstrasse 31 Bensheim. Germany D-64625

Re: K131319

Trade/Device Name: TI/T2/T3 Turbine family with serial n. > 600,000 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: April 25, 2014 Received: April 28, 2014

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 Cosmelic 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary S. Runner -S

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT 4

Indications for use

510(k) Number (if known): K131319

Device Name: T1 / T2 / T3 Turbine family with scrial n. > 600 000, Models:

TI CONTROL S ;TI CONTROL K; TI CONTROL W; TI CONTROL N; TI Boost S; TI Boost K; T1 Boost W; T1 Boost N; T1 mini K; T1 mini K; T1 mini N; T1 mini N; T2 CONTROL S; 12 CONTROL K; T2 CONTROL W; T2 CONTROL N; T2 Boost S; T2 Boost K; T2 Boost W; T2 Boost N; T2 mini S; T2 mini W; T2 mini N; T2 Boost S; T3 Boost K; T3 Boost W: T3 Boost NO: T3 mini S; T3 mini K; T3 mini W; T3 mini NQ;

Indications for Use:

The turbines of the T1 / T2 / T3 Turbine family are intended for the

Preparation of cavities and crowns
Removal of carious material
Removal of fillings
Processing of tooth and restoration surfaces
Reducing hard tooth structure

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

Andrew I. Steen -S 2014.05.30 08:48:08 -04'00'

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

Sirona Dental Systems traditional 510(k) May 1, 2013 T1 / T2 / T3 Turbine family

CONFIDENTIAL Page 3

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.