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 ART-P3 comes equipped with a turbo mode and can be operated in scaling or perio mode functions. The Bonart ART Ultrasonic Scaler ART-P3 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 EMS ,SATELEC and Bonart tips.

AI/ML Overview

The provided document is a 510(k) premarket notification for the ART Ultrasonic Scaler ART-P3. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independent performance studies to meet acceptance criteria in the same way a de novo or PMA submission might.

Therefore, the information you're looking for regarding acceptance criteria and a study proving the device meets them, especially in the context of AI/algorithm performance, multi-reader studies, and ground truth establishment, is not present in this document. The document describes a traditional medical device (ultrasonic scaler), not an AI-powered diagnostic or therapeutic device.

Here's why each point you requested cannot be addressed from this document:

Table of acceptance criteria and reported device performance: This document explicitly states in section 14.8 that "The Bonart ART Ultrasonic Scaler ART-P3 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 Ultrasonic Scaler ART-P3 conformed to all emission and immunity standards in accordance with EN and IEC regulations. Results of the testing showed that the Bonart ART Ultrasonic Scaler ART-P3 performs as intended." However, it does not provide specific quantitative acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, F1-score) or reported device performance metrics against those criteria. It only states that the device "conformed" and "performs as intended."
Sample size used for the test set and the data provenance: Not applicable. This device is not an AI/algorithm that uses test sets or data. The "performance bench testing" mentioned would refer to engineering and electrical safety tests, not data-driven human performance or AI performance tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of "ground truth" or expert review in the context of this device being an ultrasonic scaler.
Adjudication method for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable. There is no AI model to train.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) premarket notification for a physical medical device (ultrasonic scaler). The "performance data" described refers to compliance with safety and electrical standards through bench testing, not to the kind of clinical performance or AI algorithm validation you're asking about.

Summary

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MAR - 6 2000

ART Ultrasonic Scaler ART-P3 Original Premarket 510(k) Notification

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 ,TaipeiHsien, Taiwan.
C.	Company Phone:	886-2-22983980
	Company Facsimile:	886-2-22983981
d.	Contact Person:	Bankson Tsai
e.	Date Summary Prepared:	December 15, 1999
4.2.	DEVICE IDENTIFICATION
a.	Trade/Proprietary Name:	ART Ultrasonic Scaler .ART-P3
b.	Classification Name:	Ultrasonic Scaler21 CFR 872.4850

IDENTIFICATION OF PREDICATE DEVICE 14.3

Company	Device	510(k) No.	Date Cleared
SATELEC	SUPRASSON P5 Booster	K961158	05:23.96
EMS.	MiniPiezo Ultrasonic Scaler	K953026	08/28/95

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14.4 DEVICE DESCRIPTION

14.5 SUBSTANTIAL EQUIVALENCE

The Bonart ART Ultrasonic Scaler ART-P3 is substantially equivalent to the Suprasson P5 Booster in commercial distribution by SATELEC and to the miniPiezon Ultrasonic Scaler in commercial distribution by the EMS.

The fundamental technical characteristics of the Bonart ART Ultrasonic Scaler ART-P3 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 modes. There are 30 kHz power output capabilities with the Bonart ART Ultrasonic Scaler ART-P3 and the predicate devices. Power and water adjustment features are present in all units.

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 Ultrasonic Scaler ART-P3 Original Premarket 510(k) Notification

TECHNOLOGICAL CHARACTERISTICS 14.7

A comparison of the technological characteristics of the Bonart ART Ultrasonic Scaler ART-P3 with the predicate devices is provided within this submission. The Bonart ART Ultrasonic Scaler ART-P3 and the predicate devices are composed of a scaling unit, handpiece, footswitch and Tips. Both adjustable power outputs are available with the Bonart ART and the predicate devices. Turbo functions, and scaling modes are also common to each of the units.

14.8 PERFORMANCE DATA

The Bonart ART Ultrasonic Scaler ART-P3 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 Ultrasonic Scaler ART-P3 conformed to all emission and immunity standards in accordance with EN and IEC regulations. Results of the testing showed that the Bonart ART Ultrasonic Scaler ART-P3 performs as intended.

14.9 510(K) CHECKLIST

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.

Public Health Service

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 1° Road Hsinchuanq, Taipei Hsien Taiwan

Re : K994299 Trade Name: ART Ultrasonic Scaler ART-P3 Regulatory Class: II Product Code: ELC December 15, 1999 Dated: Received: December 21, 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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Paqe 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.fda.gov/cdrh/dsmamain.html".

Sincerely

iy A. Ulatowski Timo 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 Ultrasonic Scaler ART-P3 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-P3

Indication for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runno

vision Sign-C

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

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.