The Power Plus 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 Power Plus Scaler is available in two models: a 25 kHz power output and a 30 kHz power output. The Power Plus comes equipped with a turbo mode and can be operated in scaling or perio mode functions. The Power Plus 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 TPC Advance Technology tips.

AI/ML Overview

The provided document describes the "Power Plus Scaler," an ultrasonic scaler for dental cleaning.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., how much calculus removed, depth of cleaning, etc.) with numerical targets. Instead, the "acceptance criteria" are implied by the performance bench testing conducted to verify conformity to "all emission and immunity standards" and the conclusion that the device "performs as intended."

Criteria Category	Acceptance Criteria (Implied)	Reported Device Performance
Functional Performance	Device performs intended function (remove calculus deposits from teeth using ultrasonic vibrating tip).	"Power Plus Scaler performs as intended."
Bench Testing Conformity	Conforms to applicable industry and clinical standards.	"Physical performance studies were conducted to verify that the Power Plus Scaler conformed to all emission and immunity standards in accordance with EN and IEC regulations."
Emission & Immunity Standards	Conforms to all emission and immunity standards in accordance with EN and IEC regulations.	"Conformed to all emission and immunity standards in accordance with EN and IEC regulations."
Substantial Equivalence	Device is substantially equivalent to predicate devices (Parkell Turbo 25/30 Ultrasonic Scaler, Tony Riso Co. 25/30 Multi-Function Ultrasonic Scaler).	"The Power Plus Scaler is substantially equivalent to the Turbo 25/30 Ultrasonic Scaler... and to the 25/30 Multi-Function Ultrasonic Scaler."

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

The document mentions "performance bench testing in accordance with applicable industry and clinical standards" and "physical performance studies." However, it does not specify any sample size for a test set (e.g., number of teeth, number of scaling procedures, etc.).

There is no information provided on data provenance regarding country of origin or whether the data was retrospective or prospective clinical data. The studies described are bench tests, not clinical trials on human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth for any test set, as the testing described is primarily bench testing against technical standards. It does not refer to clinical evaluations or expert assessments of clinical outcomes.

4. Adjudication Method for the Test Set

Since no clinical test set requiring expert interpretation or human assessment is described, there is no adjudication method mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The studies mentioned are bench tests on the device itself, not studies comparing human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

The device described is a physical medical instrument (an ultrasonic scaler), not a software algorithm or an AI product. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this device.

7. Type of Ground Truth Used

The "ground truth" for the bench testing would be the technical specifications and regulatory standards (e.g., EN and IEC regulations for emission and immunity) that the device was tested against. There's no mention of pathology, outcomes data, or expert consensus in a clinical sense as ground truth for these tests.

8. Sample Size for the Training Set

The document does not mention a training set. This is consistent with the device being a physical instrument undergoing bench testing, not a machine learning model requiring a training dataset.

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

Since there is no training set mentioned, this information is not applicable and not provided.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters and numbers. The sequence starts with the letter 'K', followed by the number '98', and then the number '3029'. The handwriting is somewhat cursive and the numbers are not perfectly aligned.

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.

SUBMITTER INFORMATION 14.1

a.	Company Name:	TPC Advance Technology, Inc.
b.	Company Address:	1422 S. Allec Street, #DAnaheim, CA. 92805
c.	Company Phone:Company Facsimile:	(714) 758-9448(714) 758-3950
d.	Contact Person:	Chung-Liang WangPresident
e.	Date Summary Prepared:	August 28, 1998

DEVICE IDENTIFICATION 14.2.

a. Trade/Proprietary Name:	Power Plus Scaler
b. Classification Name:	Ultrasonic Scaler21 CFR 872.4850

IDENTIFICATION OF PREDICATE DEVICE 14.3

Company	Device	510(k) No.	Date Cleared
Parkell	Turbo 25/30 Ultrasonic Scaler	K950256	04/04/95
Tony Riso Co.	25/30 Multi-Function UltrasonicScaler	K964320	01/23/97

{1}------------------------------------------------

DEVICE DESCRIPTION 1 4.4

SUBSTANTIAL EQUIVALENCE 14.5

The Power Plus Scaler is substantially equivalent to the Turbo 25/30 Ultrasonic Scaler in commercial distribution by Parkell and to the 25/30 Multi-Function Ultrasonic Scaler in commercial distribution by the Tony Riso Company.

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

INTENDED USE 14.6

The Power Plus 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.

{2}------------------------------------------------

TECHNOLOGICAL CHARACTERISTICS 14.7

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

14.8 PERFORMANCE DATA

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

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal features the department's name in a circular pattern around the edge. In the center is a stylized image of an eagle with three lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 29 1999

TPC Advance Technology, Incorporated C/O Ms. Carol Patterson Consultant for TPC Advance Technology, Inc. Patterson Consulting Group, Incorporated 18140 Smokesignal Drive San Dieqo, California 92127

K983029 Re : Power Plus 25K Model, S1000, Power Plus 30K Trade Name: Model, S1001 Ultrasonic Scaler Requlatory Class: II Product Code: ELC November 11, 1998 Dated: November 12, 1998 Received:

Dear Ms. Patterson:

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 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). 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.

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

{4}------------------------------------------------

Page 2 - Ms. Carol Patterson

through 542 of 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 deborized is betantial equivalence of your device to a legally marketed predicate device results in a classification for your markets and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other qeneral 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/dsma/dsmamaip.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

{5}------------------------------------------------

Power Plus Scaler Original Premarket 510(k) Notification

INDICATION FOR USE

510(k) Number:	To Be Assigned By FDA
Device Name:	Power Plus Scaler
Indications for Use:	The Power Plus Scaler is intended for use during dentalcleaning and periodontal therapy to remove calculus depositsfrom teeth by application of an ultrasonic vibrating scaler tip tothe teeth.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ryan
(Division Sign-Off)

Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number
K983029

510(k) Number K983029

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.