The Piezo Tronic is an ultrasonic scaler intended for use during dental cleaning and periodontal (gum) therapy to remove plaque and calculus and ultrasonic vibrating scaler tip to the teeth.

Device Description

The Piezo Tronic consists of a main chassis containing a water control valve, an electric power supply, controls and displays, and ultrasonic generator. A footswitch is connected to the main chassis by a footswitch cord and a handpiece containing an ultrasonic scaler tip is connected to the main chassis by a handpiece cord.

When a dental professional has placed the tip in the proper position, the footswitch is depressed which activates the ultrasonic generator and opens the control valve to initiate water flow. The water flow and the level of ultrasonic energy delivered can be adjusted via operator accessible controls. A circular knob with an inked line on the front panel indicates the power level currently selected. Power level is adjusted by rotating the labeled knob clockwise on the front panel. Water flow is adiusted via a knob also on the front panel. When the foot switch is released, both ultrasonic energy and water flow stop immediately.

Safety of the operator and patient is ensured by compliance to IEC 601-1 and EMC 89/336/CEE.

AI/ML Overview

The provided text describes a 510(k) premarket notification for an ultrasonic scaler called "AMD Piezo Tronic." The document focuses on establishing substantial equivalence to predicate devices and describes the device's functionality and intended use. However, it does not contain information about acceptance criteria or specific studies proving the device meets performance criteria beyond safety and effectiveness.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The document is solely for a regulatory submission that focuses on equivalence.

Here's what can be extracted, albeit limited to what's available in the text:

Acceptance Criteria and Device Performance:

No specific quantitative or qualitative acceptance criteria for performance (e.g., scaling effectiveness, patient comfort, tip durability) are mentioned.
The document implies acceptance criteria revolve around substantial equivalence to predicate devices (Piezon Master 400, Dentsply Bobcat®, Cavitron® Model 3000) for its intended uses.
Implied Performance:
- Safety: Compliance to IEC 601-1 and EMC 89/336/CEE. (No specific reported performance data against these standards is provided in the summary).
- Functionality: Delivery of ultrasonic movement and water to a stainless steel tip for:
  - Periodontal pocket lavage with simultaneous ultrasonic tip movement
  - Scaling and root planing
  - Removal of supra and subgingival calculus and stains from teeth
- Equivalence to Predicates: The core claim is that it performs these functions similarly to the predicate devices.

Missing Information (Not Available in the Provided Text):

The following information cannot be provided as it is not present in the given text:

Table of Acceptance Criteria and Reported Device Performance: No such table or specific performance metrics are detailed.
Sample size used for the test set and the data provenance: No test studies or datasets are described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set evaluation is described.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No mention of such a study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
The type of ground truth used: Not applicable, as no ground truth creation process is described for performance evaluation.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary of available information related to performance/safety:

Safety Standards: The device ensures safety of the operator and patient by compliance to IEC 601-1 and EMC 89/336/CEE. (No actual test results or acceptance criteria for these standards are listed, only the statement of compliance).
Intended Use Validation (Implied by Equivalence): The device is considered substantially equivalent to predicate devices for its intended uses of scaling, root planing, and calculus/stain removal. This implies that if the predicate devices meet performance requirements for these tasks, the AMD Piezo Tronic is expected to as well, given its functional similarity.

Summary

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OCT 2 8 1998

Summary of Safety and Effectiveness for AMD Piezo Tronic

1. Date Summary was Prepared

June 15, 1998

2. Submitter's Name and Address

Advanced Medical Devices 14 Canyon Creek Village, Suite 47 Richardson, Texas 75080

3. Contact Person

Mr. Greg Holland Holland & Associates 3722 Ave. Sausalito Irvine, CA 92606

Telephone: 949-262-0411 Telefax: 949-552-2821

4. Device Name

Trade/Proprietary Name: Piezo Tronic Common Name: Ultrasonic Scaler Classification Name: Ultrasonic Scaler

5. Predicate Devices

The legally marketed devices to which equivalence is being claimed are:

. Piezon Master 400, marketed by Electro Medical Systems SA
. Dentsply Bobcat® and Cavitron® Model 3000, both marketed by Dentsply International Inc. of York, PA 17405-0872

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6. Device Description

Safety of the operator and patient is ensured by compliance to IEC 601-1 and EMC 89/336/CEE.

7. Intended Use

The Piezo Tronic is a device for delivering ultrasonic movement and water to a stainless steel tip that is used by a dentist or dental hygienist. The intended uses are:

Periodontal pocket lavage with simultaneous ultrasonic tip . movement
Scaling and root planing ●
. Removal of supra and subginqival calculus and stains from teeth

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8. Device Comparison

The Piezo Tronic is based on the Piezon Master 400 that was found substantially equivalent on August 31. 1990 (Premarket Notification K896749). The ultrasonic generator and the water delivery systems have by modified in this design, but the patient contact parts, the handpiece and the tip are functionally identical to the Piezon Master 400.

There are basically two differences between the Piezo Tronic and the Piezon Master 400. First, the Piezon Master 400 is designed to allow the use of antimicrobial irrigants. This is accomplished by using an electric pump to draw water from a bottle. to which antimicrobials can be added. The Piezo Tronic is not intended for use with antimicrobial irrigants and therefore gets its' water via a connection to the normal office water supply. Secondly, The Piezon Master 400 incorporates a two position foot switch to allow the user to select either water and ultrasound or ultrasound only. The Plezo Tronic has a single position footswitch that turns the water and ultrasound on together. In these respects the Piezo Tronic is similar to another currently marketed device, the Dentsply Cavitron Bobcat® Ultrasonic Scaler which also used tap water and incorporates a single position footswitch.

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Image /page/3/Picture/2 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. In the center of the circle is an abstract image of an eagle.

OCT 2 8 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Medical Devices C/O Mr. Greg Holland Consultant to Advanced Medical Devices 3722 Avenue Sausalito Irvine, California 92606

Re : K982793 Piezo Tronic Trade Name: Regulatory Class: II Product Code: ELC Dated: August 7, 1998 August 10, 1998 Received:

Dear Mr. Holland:

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, 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. 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Holland

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (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 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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Page 1_ of 1_

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

US. JU FAA 114 Jun 2002

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

1 0 :

The Piezo Tronic is an ultrasonic scaler intended for use during dental The Fiezo Tronio to an axrausi) therapy to remove plaque and calculus cleaning and ponodonial (gent) and ultrasonic vibrating scaler tip to the teeth.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital, Innection (

510(k) Number _

Prescription Use_ (Per 21 CFR 801.109)

"- ", "

Over-The-Counter Use

(Optional Format 1-2-96)

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.