The BONART CO., LTD. ART Ultrasonic Scaler is intended for use during dental cleaning and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Device Description

The BONART CO., LTD. ART Ultrasonic Scaler is available in two models: a 25 kHz power output and a 30 kHz power output. The Bonart ART comes equipped with a turbo mode and can be operated in scaling or perio mode functions. The Bonart ART Scaler is equipped with water adjustment and power adjustment. The unit is operated by a footswitch and comes complete with a handpiece. The handpiece is compatible with Cavitron and Bonart tips.

AI/ML Overview

The document provided describes a 510(k) submission for the BONART CO., LTD. ART Ultrasonic Scaler. This type of submission is for a medical device that is substantially equivalent to a legally marketed predicate device, and it typically relies on bench testing and comparisons to established devices rather than extensive clinical studies with specific performance metrics like those for AI/ML devices. Therefore, a direct mapping of the requested information for acceptance criteria and a study proving it is not entirely applicable in the context of this document.

However, I can extract the relevant information and explain why certain aspects of your request cannot be fulfilled based on the provided text.

Here's the breakdown of the information that can be extracted or inferred from the document:

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

The document does not provide specific quantitative acceptance criteria or detailed performance metrics in the way one would expect for an AI/ML diagnostic device with sensitivity, specificity, etc. The "performance data" section focuses on bench testing and compliance with industry standards.

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to applicable industry and clinical standards	"Physical performance studies were conducted to verify that the Bonart ART Scaler conformed to all emission and immunity standards in accordance with EN and IEC regulations."
Performance as intended (based on functional equivalence to predicates)	"Results of the testing showed that the Bonart ART Scaler performs as intended." (Intended use: dental cleaning and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.)
Substantial equivalence to predicate devices	"The Bonart ART Ultrasonic Scaler is substantially equivalent to the Power Plus Scaler... and to the 25/30 Multi-Function Ultrasonic Scaler..." "The fundamental technical characteristics of the Bonart ART Scaler are similar to those of the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The performance data section refers to "performance bench testing" but does not detail sample sizes (e.g., number of devices tested, number of hours of operation, specific types of calculus removed) or the origin/nature of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. For a device like an ultrasonic scaler, "ground truth" in the context of diagnostic accuracy established by experts is not the primary assessment method. Performance is evaluated through engineering and functional tests against specified standards and comparison to predicate devices, not typically by expert consensus on diagnostic interpretations.

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

This information is not applicable/provided. Adjudication methods are relevant for studies where multiple readers interpret cases and their interpretations need to be reconciled for ground truth establishment. This is not the type of study described for an ultrasonic scaler.

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/provided. MRMC studies and the concept of "human readers improving with AI assistance" are relevant for AI/ML diagnostic devices. The BONART ART Ultrasonic Scaler is a dental instrument, not an AI/ML diagnostic system. Its performance is assessed functionally.

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

This information is not applicable/provided. This question is relevant for AI/ML algorithms. The ART Ultrasonic Scaler is a physical device operated by a human. Its performance is always "human-in-the-loop" as it's a tool for a dental professional.

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

As mentioned, "ground truth" in the diagnostic sense is not directly applicable. The "ground truth" for this device's performance is implicit in its ability to meet engineering specifications, safety standards (emission and immunity), and functional equivalence to legally marketed predicate devices for its intended use (removing calculus deposits).

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of an ultrasonic scaler. This term is used for AI/ML algorithms.

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

This information is not applicable/provided. Again, there is no training set for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The Bonart ART Ultrasonic Scaler underwent "performance bench testing in accordance with applicable industry and clinical standards." These physical performance studies were conducted to "verify that the Bonart ART Scaler conformed to all emission and immunity standards in accordance with EN and IEC regulations."

The results of this testing "showed that the Bonart ART Scaler performs as intended." The "intended use" is "for use during dental cleaning and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth."

The primary method for demonstrating safety and effectiveness for this 510(k) submission was through substantial equivalence to predicate devices (TPC Advanced Technology Inc. Power Plus Scaler (K983029) and Tony Riso Co. 25/30 Multi-Function Ultrasonic Scaler (K964320)). The submission highlighted specific technical characteristics that were similar:

Availability of 25 kHz and 30 kHz power outputs.
Ability to operate in scaling and perio modes.
Presence of power and water adjustment features.
Equipped with a handpiece and compatibility with Cavitron brand inserts.
Inclusion of turbo functions.

Therefore, the "study" demonstrating performance was a combination of:

Bench testing to ensure compliance with relevant safety and performance engineering standards (EN and IEC).
A detailed comparison of technical and functional characteristics to legally marketed predicate devices to establish substantial equivalence for its intended use.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 14:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

14.1 SUBMITIER INFORMATION

a. Company Name:	BONART CO., LTD.
b. Company Address:	RM.405, NO. 3 Wuchuan 1st Road, Sinchuan ,Taipei Hsien, Taiwan.
c. Company Phone:	886-2-22983980
Company Facsimile:	886-2-22983981
d. Contact Person:	Bankson Tsai
e. Date Summary Prepared:	Dec. 4 .1999
14.2. DEVICE IDENTIFICATION
a. Trade/Proprietary Name:	ART Ultrasonic Scaler
b. Classification Name:	Ultrasonic Scaler21 CFR 872.4850

14.3 IDENTIFICATION OF PREDICATE DEVICE

Company	Device	510(k) No.	Date Cleared
TPC AdvancedTechnology ,Inc.	Power Plus Scaler	K983029	01/29/99
Tony Riso Co.	25/30 Multi-FunctionUltrasonic Scaler	K964320	01/23/97

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DEVICE DESCRIPTION 14.4

14.5 SUBSTANTIAL EQUIVALENCE

The Bonart ART Ultrasonic Scaler is substantially equivalent to the Power Plus Scaler in commercial distribution by TPC Advanced Technology Inc. and to the 25/30 Multi-Function Ultrasonic Scaler in commercial distribution by the Tony Riso Company.

The fundamental technical characteristics of the Bonart ART Scaler are similar to those of the predicate devices and are listed on the comparison charts provided in this 510(k) submission. The Bonart ART and the predicate devices function in the scaling and perio modes. There are 25 kHz and 30 kHz power output capabilities with the Bonart ART Scalers and the predicate devices. Power and water adjustment features are present in all units. The Bonart ART Ultrasonic Scaler and the predicate devices come equipped with handpieces and are compatible with Cavitron brand inserts.

14.6 INTENDED USE

The Bonart ART Ultrasonic Scaler is intended for use during dental cleaning and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

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ART Scaler Original Premarket 510(k) Notification

14.7 TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Bonart ART Scaler with the predicate devices is provided within this submission. The Bonart ART Scaler and the predicate devices are composed of a scaling unit, handpiece, footswitch and inserts. The Bonart ART and predicate devices are compatible with Cavitron brand inserts. Both 25KHz and 30KHz power outputs are available with the Bonart ART and the predicate devices. Turbo functions, perio and scaling modes are also common to each of the units.

14.8 PERFORMANCE DATA

The Bonart ART Scaler was subjected to performance bench testing in accordance with applicable industry and clinical standards. Physical performance studies were conducted to verify that the Bonart ART Scaler conformed to all emission and immunity standards in accordance with EN and IEC regulations. Results of the testing showed that the Bonart ART Scaler performs as intended.

510(K) CHECKLIST 14.9

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 6 2000

Mr. Bankson Tsai General Manager Bonart Co., Ltd. Room 405, No. 3 Wuchuan 186 Road Hsinchuang, Taipei Hsien Taiwan

Re : K994203 ART Ultrasonic Scaler ART-M3 Trade Name: Regulatory Class: II Product Code: ELC December 4, 1999 Dated: Received: December 13, 1999

Dear Mr. Tsai:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Tsai

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdalgov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ART Scaler Original Premarket 510(k) Notification

INDICATION FOR USE

510(k) Number :	To Be Assigned By FDA
Device Name:	BONART CO., LTD. ART Ultrasonic Scaler ART-M3
Indication for Use:	The BONART CO., LTD. ART Ultrasonic Scaler isintended for use during dental cleaning and periodontaltherapy to remove calculus deposits from teeth byapplication of an ultrasonic vibrating scaler tip to theteeth.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runoer

(Division Sign-Off) Division of Dental, Infection Control,
and General Hoopital, Infection Control, and General Hospital Device 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

CONFIDENTIAL

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.