ROLENCE Dental High Speed Handpiece, model: RHP is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

Device Description

According to ISO7785-1:1997, Dental Handpiece . -- Part 1: High-speed air turbine handpieces; and ISO13485:2003, Medical Device Quality Management System to complete the device design steps.

AI/ML Overview

The provided document is a 510(k) summary and FDA clearance letter for the ROLENCE Dental High Speed Handpiece, Model: RHP. It does not describe an AI/ML medical device, but rather a traditional medical device (a dental handpiece). Therefore, many of the requested categories for AI/ML device studies are not applicable.

Here's an analysis based on the information provided, addressing the questions where relevant:

1. Table of Acceptance Criteria and Reported Device Performance

The submission refers to international standards for device design and performance verification, rather than specific numerical acceptance criteria and reported device performance values.

Acceptance Criteria (Reference Standard)	Reported Device Performance (Compliance)
ISO7785-1:1997, Dental Handpiece -- Part 1: High-speed air turbine handpieces	Verified function test according to ISO7785-1
ISO13485:2003, Medical Device Quality Management System	Device design steps completed according to ISO13485
ISO14971:2007, Medical devices – Application of risk management to medical devices	Risk Management Report completed according to ISO14971

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

Not applicable for this type of traditional medical device. The "test set" here refers to the physical device prototypes being tested against engineering standards. The data provenance would be the manufacturing site (Taiwan R.O.C.) where the verification tests were conducted.

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

Not applicable in the context of an AI/ML device. For this traditional device, the "ground truth" is defined by the technical specifications and performance requirements established in the referenced ISO standards. The individuals conducting the tests would be qualified engineers and technicians.

4. Adjudication Method for the Test Set

Not applicable in the context of an AI/ML device. Device testing against standards doesn't typically involve adjudication.

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 traditional dental handpiece, not an AI-assisted device.

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

Not applicable. This is a manual device operated by a human professional.

7. The Type of Ground Truth Used

For this traditional medical device, the "ground truth" for demonstrating substantial equivalence and performance relies on:

Conformance to International Standards: Specifically, ISO7785-1 for functional verification, ISO13485 for design processes, and ISO14971 for risk management.
Comparison to Predicate Device: The primary method for establishing substantial equivalence was a comparison of formulations and intended uses with the JINDELL High Speed Air Turbine Handpiece (K062740).

8. The Sample Size for the Training Set

Not applicable. This is a traditional medical device, not an AI/ML device that requires a training set.

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

Not applicable. There is no training set for this device.

Summary

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-K093084

Rolence Enterprise Inc. 18-3 Lane 231 PuChung Rd. ChungLi 320 Taiwan R.O.C. Tel: +886-3-463 1999 ext 10 Fax: +886-3-463 1997

5. 510(K) SUMMARY

DEC 1 6 2009

ROLENCE Dental High Speed Handpiece, Model: RHP

510K:
Submitted by:	ROLENCE Enterprise Inc.
	No.18-3, Lane 231, Pu Chung Rd., Chungli, 32083,
	Taiwan, ROC
Contact person:	Dr. Jen, Ke-Min
	No.58, Fu-Chiun Street, Hsin-Chu City, 30067,
	Taiwan, ROC
	Tel: 886-3-5208829 fax: 886-3-5209783
	E-mail: ceirs.jen@msa.hinet.net
Date Summary Prepared:	September 18, 2009
Name of the Device:	Dental Air-Powered Handpiece
Classification:	Dental Air-Powered Handpiece ( class I medical
	device; 21 CFR 872.4200 )
	Product code: EFB
	Panel: 72
Proprietary name:	ROLENCE Dental High Speed Handpiece, model RHP
Predicate Device:	JINDELL High Speed Air Turbine Handpiece,
	models: SW, SP, SU, ETU, MU; 510K No – K062740
Statement of Intended Use:	The ROLENCE Dental High Speed Handpiece,
	model RHP is intended for removing carious
	material, reducing hard tooth structure, cavity
	preparation, finishing tooth preparations and
	restorations and polishing teeth.
	CAUTION: U.S. Federal law restricts the use of
	this device to licensed professionals.

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Rolence Enterprise Inc. 18-3 Lane 231 PuChung Rd. ChungLi 320 Taiwan R.O.C. Tel: +886-3-463 1999 ext 10 Fax: +886-3-463 1997

Description of Device Design: According to ISO7785-1:1997, Dental Handpiece . -- Part 1: High-speed air turbine handpieces; and ISO13485:2003, Medical Device Quality Management System to complete the device design steps.
Risks Analysis Method: According to ISO14971:2007, we completed the Risks ● Management Report for the ROLENCE Dental High Speed Handpiece.
Performance Data: The claim of substantial equivalence is based on . comparisons of formulations and intended uses of the ROLENCE Dental High Speed Handpiece, model RHP and its claimed predicate.

And we also refer to the ISO7785-1 to verify the function test for the ROLENCE Dental High Speed Handpiece.

Conclusion: Based on the information in the notification, ROLENCE . Enterprise Inc. believes that the Dental High Speed Handpiece is substantially equivalent to the claimed predicate JINDELL High Speed Air Turbine Handpiece, models: SW, SP, SU, ETU, MU, 510K No. K062740.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

DEC 1 6 2009 ROLENCE Enterprise Incorporated C/O Mr. Shu-Chen Cheng ROC Chinese-European Industry Research Society 2064 Tamarin Drive Columbus, Ohio 43235

Re: K093084

Trade/Device Name: Rolence Dental High Speed Handpiece Model RHP Regulation Number: 21CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 20, 2009 Received: October 1, 2009

Dear Mr. Cheng:

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 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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Page 2- Mr. Cheng

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/SafetyReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

. for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Rolence Enterprise Inc. 18-3 Lane 231 PuChung Rd. ChungLi 320 Taiwan R.O.C. Tel: +886-3-463 1999 ext 10 Fax: +886-3-463 1997

Indications for Use

510 (K) Number ( If Known ): _ K (J 9 3084

ROLENCE Dental High Speed Handpiece, Model: RHP ● Device Name:

Indications for Use :

· ROLENCE Dental High Speed Handpiece, model: RHP is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
• ROLENCE Dental High Speed Handpiece carries the following label:

CAUTION: U.S. Federal law restricts the use of this device to licensed professionals.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kevin Muly for MSR
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K093084

Page 1 of l

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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.