The Ultrasonic scaler employs piezoelectric technology to produce a steady power. It is composed of a control unit housing a generator that produces piezo-electric vibrations. The working instrument for the ultrasonic scaler is the handpiece, which is connected to the control unit via a handpiece cord. A scaling tip specific to a particular procedure is attached to the end of the handpiece. The ultrasonic scaler models VET-W3 and VST-W3 connect to an external water supply and delivers water via connected handpiece.
Ultrasonic scaler consists of main generator, VE and VS handpiece, optional scaler tips (G series, P series, E series), power adapter and foot switch;
The main part is as follows:

Power adapter: DC 24V, input frequency: 3-20W
Main engine: The main engine is the major part of the circuit control, including ultrasonic pulse circuit, modulator circuit and oscillatory circuit. It is used for converting the ultrasonic oscillatory signal to ultrasonic mechanical oscillatory signal by magnifying and improving the vibrating frequency.
Handpiece: It mainly converts the signal from circuit,which will drive the ultrasonic scaler tips vibrating.
Scaler tip: The scaler tip is used to remove the calculus and plague by vibrating on the teeth surface.

AI/ML Overview

This document describes a 510(k) premarket notification for an Ultrasonic Scaler, which is a dental device. The request asks for details related to acceptance criteria and a study proving the device meets those criteria, typically found in submissions for Artificial Intelligence (AI) or machine learning (ML) enabled medical devices.

However, the provided text does NOT describe an AI/ML-enabled device or a study designed to evaluate its performance against specific acceptance criteria for AI/ML outputs.

The document states:

"Clinical evaluation is not applicable for the proposed device." (Page 6)
The comparison is primarily focused on technological characteristics and bench testing against existing standards (IEC, ISO), not clinical performance metrics related to AI/ML.
The device is an "Ultrasonic Scaler" for removing calculus and stain, periodontal pocket lavage, and root canal cleaning. This is a mechanical device, not described as having any AI or ML components.

Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to the content of this 510(k) submission.

Based on the provided text, I can only address how the device's equivalence and safety were established, not how an AI/ML component meets specific performance criteria.

Summary of Device Acceptance (for a non-AI/ML device based on this 510(k)):

The acceptance of the "Ultrasonic Scaler" (Models VET-W3, VST-W3, VET-1, VST-1) is based on demonstrating substantial equivalence to a legally marketed predicate device (Nanning Baolai Medical Instruments Co., Ltd.'s Ultrasonic scaler P7, K140233) rather than proving performance against specific AI/ML acceptance criteria.

The acceptance involves showing the proposed device has the same intended use, similar product design, same sterilization conditions, and comparable technological characteristics as the predicate device. Bench testing against recognized international standards was conducted to support safety and performance.

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria (for Substantial Equivalence to Predicate)	Reported Proposed Device Performance/Characteristics	Comments
Intended Use (same as predicate)	The ultrasonic scaler is intended to: 1. Remove supra and sub gingival calculus deposits and stain from the teeth; 2. Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement; 3. Clean and irrigate root canals.	Same as predicate device.
Technological Characteristics (similar to predicate)	Working Principle: Piezoelectric effect (same as predicate) Sterilization: Handpiece: autoclaved 135°C/0.22MPa; Scaler tip: autoclaved high temp/pressure (same as predicate) Operating Conditions: Temp 5-40℃, RH 30-80%, Pressure 50-106kPa (same as predicate) Storage Conditions: Temp -10-+50℃, RH ≤ 80%, Pressure 50-106kPa (same as predicate)	Key technological aspects are similar.
Power Supply (meet safety standards)	Input voltage: 30VDC 50HZ; Output power: 3-20W. (Predicate: 24VDC 1.5A 50HZ, 3-20W)	Slight difference in input voltage, but both meet IEC 60601-1.
Safety and Performance Standards Compliance	IEC 60601-1:2006+A1:2012 (Electrical safety) IEC 60601-1-2:2007 (EMC) IEC 61205:2001 (Measurement & declaration of output characteristics) ISO 10993-5:2009 (Biocompatibility - cytotoxicity) ISO 10993-10:2010 (Biocompatibility - irritation/sensitization)	All listed standards were used for non-clinical bench testing.
Software Level of Concern	Moderate (same as predicate)	Addressed as "Moderate." (Details on software testing not provided in text).

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

Not applicable for AI/ML performance testing.
The device underwent bench testing against international standards (IEC, ISO). This typically involves testing a few representative units to confirm compliance with electrical safety, EMC, performance characteristics, and biocompatibility. The specific number of units tested is not detailed in this summary, but it would not be a "sample size" in the context of AI/ML validation with a large dataset.
Data provenance for such tests would be from the manufacturer's internal testing labs, likely in China (based on submitter's address). These are prospective tests performed to demonstrate compliance.

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

Not applicable. This device is not an AI/ML device requiring human expert annotation for ground truth. Ground truth for this device is based on physical measurements of device characteristics against engineering and safety standards.

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

Not applicable. There was no human reader/adjudication involved in establishing ground truth for performance of this mechanical device.

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:

No, this was not done. This is a mechanical dental device, not an AI/ML tool designed to assist human readers.

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

Not applicable. This is not an algorithm. Device performance was assessed via bench tests.

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

For this type of device, "ground truth" is typically defined by established engineering standards and specifications. For example, electrical safety is confirmed by measuring parameters against limits set in IEC 60601-1, and biocompatibility is assessed by testing against ISO 10993 standards. It's objective measurement against a known reference, not human expert consensus on diagnostic image interpretation.

8. The sample size for the training set:

Not applicable. This device does not use an AI/ML training set.

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

Not applicable. This device does not have a training set or associated ground truth.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 21, 2017

Nanning Vv Dental Co., Ltd. Liang Chaojun Vice General Manager 4th Floor,north Bld. No.1 , Zhengxin Tech Zone, No. 2, Gaoxin 7 Rd. Nan Ning, 530007 CN

Re: K163414

Trade/Device Name: Ultrasonic Scaler Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: elc Dated: October 25, 2017 Received: October 27, 2017

Dear Liang Chaojun:

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. 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.

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

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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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Sincerely,

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for Tina Kiang, Ph.D. 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

510(k) Number (if known) K163414

Device Name

Ultrasonic Scaler

Indications for Use (Describe)

The ultrasonic scaler is intended to:

1. Remove supra and sub gingival calculus deposits and stain from the teeth;
1. Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement;

3.Clean and irrigate root canals

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K163414 510(k) SUMMARY

(As Required by 21 CFR 807.92)

1. Date Prepared October 2nd, 2017

2. Submitter;s Information

Company Name:	NANNING VV DENTAL CO., LTD.
Company Address:	4th floor,North Bld. No.1, Zhengxin Tech Zone
	No. 2, Gaoxin 7 Rd., Nanning, China 530007
Fax:	0086-771-580-1312

3. Device Information

Trade Name:
Models:
Product Code:
Regulation Number:
Device Class:

Ultrasonic Scaler VET-W3, VST-W3, VET-1 and VST-1 ELC 21 CFR 872.4850 Class II

4. Identification of Predicate Devices

Predicate I

Manufacturer:	Nanning Baolai Medical Instruments Co., Ltd.
Trade Name:	Ultrasonic scaler P7
Product Code:	ELC
Classification Name:	Ultrasonic Scaler
Regulation Number :	21 CFR 872.4850
FDA 510 (k) #:	K140233

5. Description of the Device

[510(k)] Application

SECTION 7 - 1 of 5

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Ultrasonic scaler consists of main generator, VE and VS handpiece, optional scaler tips (G series, P series, E series), power adapter and foot switch;

The main part is as follows:

1. Power adapter: DC 24V, input frequency: 3-20W

Main engine: The main engine is the major part of the circuit control, including ultrasonic pulse circuit, modulator circuit and oscillatory circuit. It is used for converting the ultrasonic oscillatory signal to ultrasonic mechanical oscillatory signal by magnifying and improving the vibrating frequency.
Handpiece: It mainly converts the signal from circuit,which will drive the ultrasonic scaler tips vibrating.
Scaler tip: The scaler tip is used to remove the calculus and plague by vibrating on the teeth surface.

6. Indications For Use

The ultrasonic scaler is intended to:

1.Remove supra and sub gingival calculus deposits and stain from the teeth; 2.Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement; 3.Clean and irrigate root canals

7. Technological Characteristics

The ultrasonic scaler is powered by the piezoelectric technology, which is also employed by the predicate device. The electric power is transduced into high- frequency vibration via an ultrasonic transducer. The proposed ultrasonic scaler connects to an external water supply and delivers water via connected handpiece.

Items	K163414 Proposed Device	K140233 Predicate DeviceUltrasonic scaler P7
IndicationsFor Use	The ultrasonic scaler is intended to:1.Remove supra and sub gingivalcalculus deposits and stain fromthe teeth;	The ultrasonic scaler is intendedto:1.Remove supra and sub gingivalcalculus deposits and stain from theteeth;
	2. Carry out periodontal pocket lavagewith simultaneous ultrasonic tipmovement;3. Clean and irrigate root canals.	2. Carry out periodontal pocketlavage with simultaneousultrasonic tip movement;3. Clean and irrigate root canals.
OperationControls
	Sterilization:Handpiece: autoclaved under hightemperature 135°C/pressure 0.22MPa.Scaler tip: autoclaved under hightemperature and high pressure	Sterilization:Handpiece: autoclavedunder high temperature 135°C/pressure0.22MPa. Scaler tip: autoclaved underhigh temperature and pressure.
DisplayModes	Corresponding signal of externaldisplay driver circuit lights upcorresponding LED.	Corresponding signal of externaldisplay driver circuit lightsup corresponding LED.
MeasurementItems	Remove calculus or plaque on surfaceof teeth in oral cavity, cleaning andirrigation of root canals.	Remove calculus or plaque on surfaceof teeth in oral cavity, cleaning andirrigation of root canals.
PowerSupply	input voltage : 30VDC 50HZoutput power : 3-20W	input voltage : 24VDC 1.5A 50HZoutput power : 3-20W
Operatingconditions	temperature : 5℃~40℃relative humidity : 30%~~80%pressure : 50kPa~~106kPa	temperature : 5℃~~40℃relative humidity : 30% ~ 80%pressure : 50kPa~~106kPa
Storageconditions	temperature : -10℃~~+50℃relativehumidity ≤ 80%pressure50kPa~~106kPa	temperature : -10℃~~+50℃relativehumidity ≤ 80%pressure50kPa~~106kPa
Handpiece ofultrasonicscaler	Working principle: Piezoelectriceffect, the ultrasonic vibration signalis converted to ultrasonic mechanicalvibration signal.	Working principle: Piezoelectric effect,the ultrasonic vibration signal isconverted to ultrasonic mechanicalvibration signal.
Tips ofultrasonicscaler	Mechanical vibration transmittedfrom the handpiece is converted tothe vibration of the scaler tip, thenremoves calculus or plaque from theteeth.	Mechanical vibration transmitted fromthe handpiece is converted to thevibration of the scaler tip, thenremoves calculus or plaque from theteeth.
ElectricalSafety	IEC 60601-1	IEC 60601-1
EMC	IEC 60601-1-2	IEC 60601-1-2
performance	IEC 61205	IEC 61205
Biocompati-bility	ISO 10993-5,ISO 10993-10	ISO 10993-5,ISO 10993-10
SoftwareLevel ofConcern	Moderate	Moderate

8. Substantial Equivalence Table

[510(k)] Application

SECTION 7 - 2 of 5

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SECTION 7 - 3 of 5

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The proposed device has same intended use, similar product design, same sterilization condition, safety standards as the predicate device. The slight difference is the power supply, the input voltage of proposed device is 30V DC , the input voltage of predicate device is 15V DC, both of them could meet the electricity safety standard IEC 60601-1, the difference does not affect the substantial equivalence in effectiveness and safety.

Non-clinical Testing:

The following bench testing was conducted in order to support substantial equivalence of the proposed device:

IEC 60601-1:2006+A1:2012 medical electrical equipment -- part 1: general ● requirements for basic safety and essential performance
. IEC 60601-1-2:2007 medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
IEC 61205:2001 Ultrasonics-Dental descaler systems-Measurement and declaration of the output characteristics.
. ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
. ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.

Clinical Testing:

Clinical evaluation is not applicable for the proposed device.

9. Conclusion [21 CFR 807.92(b)(3)]

The VET-W3, VST-W3,VET-1 and VST-1 ultrasonic scaler have the same intended use, similar product design, same sterilization conditions and the same technological characteristics as the predicate device. Nonclinical testing further supports the substantial equivalence of the proposed device to its predicate device. Therefore, the proposed device is substantially equivalent to its predicate device.

[510(k)] Application

SECTION 7 - 4 of 5

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PSC Publishing Services (301) 443-6740 Fir

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.