ProAngle™ disposable prophy angle is a device intended to polish and clean the surface of teeth. It should be attached to a low speed handpiece for operation.

Device Description

ProAngle™ disposable prophy angle is a device used for polishing and cleaning the surface of teeth. It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth.

AI/ML Overview

The provided text is a 510(k) summary for a dental device, the "ProAngle™ disposable prophy angle." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance in the way a clinical trial for a diagnostic AI device would.

Therefore, many of the requested categories for a clinical study with acceptance criteria simply do not apply to this type of submission.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence: The device must be demonstrated to be "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. This is the primary "acceptance criterion" for a 510(k) submission.	The document explicitly states: "ProAngle™ disposable prophy angle is substantially equivalent to other legally marketed devices in the United States. ProAngle™ disposable prophy angles function in a same manner and have the same use as the disposable prophy angle designed by AllPro, Inc." The FDA's letter (K030603) confirms this finding: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (...) to legally marketed predicate devices..." Regarding specific performance, the document describes the device's function: "It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth." The intended use is "for polishing and cleaning teeth." No specific quantitative performance metrics (e.g., polishing efficiency, wear resistance, noise levels) are provided or required for this type of submission focused on substantial equivalence to a well-established device type.

Acceptance Criteria

Reported Device Performance

Substantial Equivalence: The device must be demonstrated to be "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. This is the primary "acceptance criterion" for a 510(k) submission.

The document explicitly states: "ProAngle™ disposable prophy angle is substantially equivalent to other legally marketed devices in the United States. ProAngle™ disposable prophy angles function in a same manner and have the same use as the disposable prophy angle designed by AllPro, Inc." The FDA's letter (K030603) confirms this finding: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (...) to legally marketed predicate devices..." Regarding specific performance, the document describes the device's function: "It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth." The intended use is "for polishing and cleaning teeth." No specific quantitative performance metrics (e.g., polishing efficiency, wear resistance, noise levels) are provided or required for this type of submission focused on substantial equivalence to a well-established device type.

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

This information is not applicable and not provided in the 510(k) summary. A 510(k) for a Class I device like this typically relies on a comparison to a predicate device and adherence to general controls, not on a new clinical study with a test set of patients or data. The "test set" in this context is the comparison between the new device's design/function and the predicate device's design/function.

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

This information is not applicable. No "ground truth" establishment by experts in a clinical study context is described or required for this 510(k) submission focused on substantial equivalence of a general dental tool. The "ground truth" for the predicate device's safety and effectiveness would have been established historically through its prior marketing and use.

4. Adjudication Method for the Test Set

This information is not applicable. No adjudication method is described as there isn't a "test set" in the context of a clinical performance study.

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. This device is a manual dental tool, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI-related effect sizes are entirely irrelevant.

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

This information is not applicable. The device is a physical dental tool, not an algorithm, so a standalone algorithm performance evaluation is not relevant.

7. The Type of Ground Truth Used

This information is not applicable in the context of a clinical "ground truth" from pathology or outcomes data. The "ground truth" for this 510(k) is the established safety, effectiveness, and intended use of the predicate device (Allpro, Inc., Disposable prophy angle) as determined by its prior marketing clearance. The new device is simply confirming it matches this established "ground truth."

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" for an algorithm or a clinical study mentioned in this 510(k) submission.

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

This information is not applicable. As there is no training set mentioned, the method for establishing its ground truth is also not mentioned.

Summary

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K030603

Pac-I)ent International (Suzhou), Inc.

510(k) Summary of Safety and Effectiveness

Submitter:

Pac-Dent International (Suzhou), Inc. 1 25 Binhe Road, New District of Suzhou City, J angsu Province, P. R. China Phone: 86-512-68085091 Fax: 86-512-68085092 Contact Person: Xu Wang Fhone: 909-839-0888 F ax: 909-839-0881 I Date Summary Prepared: Feb.2003

l)evice Name:

"rade Name: ProAngle™ disposable prophy angle Common Name: Disposable prophy angle ( Classification Name: Handpiece, contra and right angle attachment (Classification: Class I

Devices for Which Substantial Equivalence is Claimed:

Allpro,Inc., Disposable prophy angle

Device Description:

?roAngle™ disposable prophy angle is a device used for polishing and cleaning the surface of teeth. It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth.

Intended Use of the Device:

The intended use of the ProAngle™ disposable prophy angle is for polishing and cleaning teeth.

Substantial Equivalence:

ProAngle™ disposable prophy angle is substantially equivalent to other legally marketed devices in the United States. ProAngle™ disposable

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prophy angles function in a same manner and have the same use as the disposable prophy angle designed by AllPro, Inc.

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Image /page/2/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 curved lines representing its wings. The eagle is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font. The text is arranged around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2003

Mr. Xu Wang General Manager Pac-Dent International (Suzhou) Limited 125 Binhe Road, New District of Suzhou City, Jiangsu Province, P.R. CHINA

Re: K030603

Trade/Device Name: ProAngle™ Disposable Prophy Angle Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: February 18, 2003 Received: February 25, 2003

Dear Mr. Wang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), ' please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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.

Super Runner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for use statement

Applicant: Pac-Dent International (Suzhou), Ltd.

510(k) Number no 30603

C evice Name: ProAngle™ disposable prophy angle

Indications For Use:

F roAngle™ disposable prophy angle is a device intended to polish and clean t 1e surface of teeth. It should be attached to a low speed handpiece for operation.

Kein Mulkey for MSM
(Division Sign-Off)

n of Anesthesiolog General Hospital. Infection Control, Denta

510(k) Number: K 030603

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.