The device is a disposable dental prophylaxis angle which consists of a plastic body integrally formed with a drive mechanism, and a rubber cup that attaches to a retention knob or stud on the angle. The prophy angle has a slot for connecting the angle to a dental handpiece, which powers the prophy angle. The drive shaft of the prophy angle allows the rubber prophy cup to rotate.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental prophylaxis angle. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with explicit acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the given document.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety: Device does not cause serious injury or death.	No serious injury or death events reported in MDRs from 1992-1996 for prophy angles.
Safety: Device malfunctions (stalling, locking, drive gears coming apart, heating, rubber cup coming off) do not result in injury.	Malfunctions (stalling, locking, drive gears coming apart, heating, rubber cup coming off) were reported, but no injuries were attributed to these malfunctions.
Effectiveness: Cleans and polishes teeth.	The submission asserts that the differences in design between the Pro-Flex™ and the predicate device "do not impact the safety and effectiveness of the device in any significant way since the function and intended use are the same." This implies an acceptance criteria that the device performs its intended function of cleaning and polishing teeth, similar to the predicate. No specific quantitative performance metrics (e.g., polishing efficiency, cleaning efficacy) are provided.
Substantial Equivalence: Technological characteristics are nearly identical or very minor differences that do not affect safety/effectiveness compared to the predicate device.	"The differences in design between the Pro-Flex™ and the predicate device are very minor and do not impact the safety and effectiveness of the device in any significant way since the function and intended use are the same."

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

This document does not describe a clinical "test set" in the context of typical algorithm evaluation. The safety assessment relied on a retrospective review of existing Medical Device Records (MDRs).

Sample Size: Over 200 MDRs filed with CDRH between 1992 and 1996 for prophy angles. This is not a direct test set for the Pro-Flex™ device itself, but rather a review of adverse events for similar devices.
Data Provenance: The MDRs were "filed with CDRH" (Center for Devices and Radiological Health), implying a national/international scope as reported to the FDA in the USA. The data is retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The safety assessment involved a review of adverse event reports, not an expert panel establishing ground truth for a test set in a typical clinical study.

4. Adjudication Method for the Test Set

Not applicable. There was no explicit "adjudication method" for a test set. The review involved an analysis of reported incidents in MDRs.

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

Not applicable. This is a medical device (dental prophylaxis angle), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the safety assessment, the "ground truth" was based on reported adverse events and malfunctions documented in Medical Device Records (MDRs). For the effectiveness, the claim of "substantial equivalence" implies that the new device is functionally identical to the predicate device, which is presumably safe and effective based on its prior market clearance.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is a physical medical device following a 510(k) pathway, not an AI/machine learning model.

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

Not applicable. No training set was used.

Summary

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Ka81869

SUMMARY OF SAFETY AND EFFECTIVENESS -

1. Name and Address

This Summary of Safety and Effectiveness is being submitted by Professional Dental Manufacturing, Inc., 633 Lawrence Street, Batesville, Arkansas 72501. The telephone number is 870-698-2300.

2. Name of the Device

The device is generally known as a dental prophylaxis angle.

3. Identification of Predicate Device(s)

Dentsply's NUPRO® Disposable Prophy Angle.

4. Description of the Device

5. Intended Use of the Device

Professional Dental Manufacturing, Inc.'s Pro-Flex™ Disposable Prophy Angle is intended for one time use by dental professionals during general prophylaxis. Pro-Flex™ is used to clean and polish teeth by application of a prophy angle with a rotating rubber cup, combined with a cleaning and polishing paste or powder, to the surfaces of teeth.

6. Comparison of Technological Characteristics

The differences in design between the Pro-Flex™ and the predicate device are very minor and do not impact the safety and effectiveness of the device in any significant way since the function and intended use are the same.

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7. Safety

Professional Dental Manufacturing, Inc. reviewed the Medical Device Records (MDR) filed with CDRH during the period from 1992 through 1996 for information on prophy angles which may have caused a death or serious injury. Of the more than 200 MDRs filed, no serious injury events were reported. A single MDR indicated that a disposable prophy angle purportedly caused grooves or wearing away of enamel on the facial aspects of several teeth.

The other events reported were malfunctions falling into one of the following categories: the prophy angle stalled or locked up, the drive gears came apart, or the angle got hot. Several events reported that the rubber cup came off the prophy angle, occasionally in the patient's mouth, but no injuries were reported due to this or the other described malfunctions.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG | | | 1998

Bob Zahradnik, Ph.D. Professional Dental Manufacturing, Inc. 633 Lawrence Street Batesville, Arizona 72501

Re : K981869 Pro-Flex™ Disposable Prophy Angle Trade Name: Requlatory Class: I Product Code: EFB Dated: May 28, 1998 Received: May 28, 1998

Dear Dr. Zahradnik:

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 aqainst 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Zahradnik

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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 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/dsma/dsmamain.html".

Sincerely yours,

S. Dutram fr

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):
Device Name:	Pro-Flex™ Disposable Prophy Angle
Indications For Use:	For one time use as part of a professionally administered prophylaxis treatment, to clean and polish teeth.

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and the control control control of the control of

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K981869

Prescription Use	OR	Over-the-Counter Use ______
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Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.