Tiger 500 Series High Speed Handpieces and Attachments are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

Device Description

The Tiger 500 series High Speed Handpieces and Attachments are similar to other high-speed dental handpieces currently on the US dental market in design, function, and intended use. The devices are air-powered handpieces that are reusable and ergonomically shaped, and are provided both with and without a fiber optic light system. The devices are supplied non-sterile, but must be sterilized before use, as with the predicate device. It will be packaged as a single-use bag. Several models could be connected to couplings of manufacturers including TTBIO, KaVo, NSK Mach, Sirona, and Star. According to IS07785-1:1997, Dental Handpiece-- Part 1: High-speed air turbine handpieces; and IS013485:2003, Medical Device Quality Management System to complete the device design steps.

AI/ML Overview

The provided text is a 510(k) summary for the Thunder Tiger 500 Series High Speed Handpieces and Attachments. This document primarily focuses on establishing "substantial equivalence" to existing predicate devices, rather than presenting a study to prove a device meets specific acceptance criteria based on performance metrics (like sensitivity, specificity, accuracy, etc.) that would typically be found in an AI/software as a medical device (SaMD) submission.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not applicable or extractable from this type of regulatory document for a traditional medical device.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available or relevant to this type of submission:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" is demonstrating substantial equivalence to predicate devices, primarily through comparison of technological characteristics and adherence to relevant standards. Performance is verified against mechanical and safety standards rather than clinical metrics.

Acceptance Criteria (from ISO 7785-1 for dental handpieces)	Reported Device Performance (based on "Substantial Equivalence Table")	Comments
Functional Verification	"The functions of Tiger 500 series High Speed Handpieces and Attachments were verified according to ISO7785-1."	This indicates that the device met the functional requirements specified by the ISO standard.
Safety Data	"The performance and safety of the Tiger 500 series High Speed Handpieces and Attachments are based upon conformity with applicable aspects of ISO 7785-1. Bench testing results demonstrate substantially equivalence."	Compliance with safety aspects of ISO 7785-1 and other standards (ISO 13485) ensures the device is safe.
Substantial Equivalence to Predicate Devices	"Technological Characteristics" table (see below) demonstrates similarity/identity across various aspects.	This is the primary "performance" metric for a 510(k) submission, confirming it's as safe and effective as existing devices.

Substantial Equivalence Table (from the document):

TECHNOLOGICAL CHARACTERISTIC	COMPARISON TO PREDICATE
Intended use	Identical
Indications for use	Identical
Target population	Identical
Anatomical sites	Identical
Energy used and/or delivered	Similar
Human factors	Similar
Design	Similar
Performance	Similar
Standards met	Identical
Materials	Similar
Biocompatibility	Identical
Compatibility with environment and other devices	Identical
Sterility	Identical
Mechanical safety	Identical
Chemical Safety	Identical
Thermal safety	Identical
Radiation safety	Identical

2. Sample size used for the test set and the data provenance

Sample size: Not applicable. This is a traditional medical device (dental handpiece), not a software/AI device that undergoes testing with a "test set" of data samples. The evaluation is based on bench testing of the physical device and comparison to standards and predicate devices.
Data provenance: Not applicable in the context of data samples. The device itself is manufactured in Taiwan, ROC (Thunder Tiger Corp., Taichung).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no "test set" or "ground truth" established by experts in the context of clinical data for this type of device. Regulatory bodies (like the FDA) and standards organizations (like ISO) define the requirements, and the manufacturer performs testing to demonstrate compliance.

4. Adjudication method for the test set

Not applicable. No "test set" (of data) or adjudication process regarding expert opinions is described.

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 device is a physical dental handpiece, not an AI or diagnostic imaging device. An MRMC study is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

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

7. The type of ground truth used

The "ground truth" in this context is adherence to established international standards (ISO 7785-1:1997 for dental handpieces; ISO 13485:2003 for Quality Management Systems) and demonstrating substantial equivalence to legally marketed predicate devices. The "truth" is that the device meets these engineering specifications and performs comparably to existing, approved devices.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable. As above, this is not an AI/software device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Thunder Tiger. The logo consists of a circle with an airplane inside of it on the left. To the right of the circle is the text "Thunder Tiger" written in a stylized font, with the word "Thunder" on top of the word "Tiger".

THUNDER TIGER CORP. APR 2 7 2011 NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG. TAIWAN. R.O.C. 40755 TEL : 886-4-23591616 FAX : 886-4-23591902 E-mail: tt@thundertiger.com http://www.thundertiger.com

K10 2517 510(K) SUMMARY

Tiger 500 Series High Speed Handpieces and Attachments

Date Summary Prepared: December 20,2010
Submitter Information

510(k) Owner: THUNDER TIGER CORP.

No.7, 6th Road, Industry Park, Taichung, 40755

Taiwan, ROC

Contact Person: Jo S.C. Lee/QA Engineer

jo@thundertiger.com

Device Name

-Trade-Name :- Tiger-500 Series-High-Speed-Handpieces-and-Attachments-

Common Name: Dental Handpiece

Classification Name: Handpiece, Air-Powered, Dental

(21 CFR 872.4200, Product Code EFB)

Predicate Device: Dental Air-Powered Handpiece, models TIGER 300T, TIGER 300K,

TIGER 300W, TIGER 300B, TIGER 300N (K062812)

SUPERtorque High-Speed Handpieces (K073478)

Tradition high speed Handpiece (K863677)

Rapidd high speed Handpiece (K003518)

Device Description:

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K102517

Image /page/1/Picture/1 description: The image shows the logo for Thunder Tiger. The logo consists of a circle with an airplane inside of it on the left side. To the right of the circle, the words "Thunder Tiger" are written in a bold, sans-serif font, with the word "Thunder" on top of the word "Tiger".

THUNDER TIGER CORP. NO.7. 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23591616 FAX : 886-4-23591902 E-mail: tt@thundertiger.com http://www.thundertiger.com

Intended Use: 6.
Tiger 500 Series High Speed Handpieces are 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.

Technological Characteristics:

The functions of Tiger 500 series High Speed Handpieces and Attachments were verified according to ISO7785-1. The substances of Tiger 500 series High Speed Handpieces are same as the predicate device in terms of its intended use, operating principles and functions.

1. Non-Clinical Performance/Safety Data:
  The performance and safety of the Tiger 500 series High Speed Handpieces and Attachments are based upon conformity with applicable aspects of ISO 7785-1. Bench testing results demonstrate substantially equivalence. Therefore, we conclude that the both safe and effective for its intended use.

Substantial Equivalence Table
TECHNOLOGICAL CHARACTERISTIC	COMPARISON TO PREDICATE
Intended use	Identical
Indications for use	Identical
Target population	Identical
Anatomical sites	Identical
Energy used and/or delivered	Similar
Human factors	Similar
Design	Similar
Performance	Similar
Standards met	Identical
Materials	Similar
Biocompatibility	Identical
Compatibility with environment and other devices	Identical
Sterility	Identical
Mechanical safety	Identical
Chemical Safety	Identical
Thermal safety	Identical
Radiation safety	Identical

Substantial Equivalence

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Image /page/2/Picture/1 description: The image shows the logo for Thunder Tiger. The logo consists of a circle with an airplane in the middle, and the words "Thunder Tiger" written in a stylized font to the right of the circle. The words "Thunder" and "Tiger" are stacked on top of each other, with a line above and below each word.

THUNDER TIGER CORP. NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 FAX : 886-4-23591902 TEL : 886-4-23591616 E-mail: tt@thundertiger.com http://www.thundertiger.com

10. Conclusion:

The above descriptions coincide with the substantial equivalence made by Dental Air-Powered Handpiece, models TIGER 300T, TIGER 300K, TIGER 300W, TIGER 300B, TIGER 300N (K062812), SUPERtorque High-Speed Handpieces (K073478), Tradition high speed Handpiece (K863677) and Rapidd high speed Handpiece (K003518). They are same as the predicate device in terms of its intended use, operating principles and functions. Therefore, it can be seen that Tiger 500 series High Speed Handpieces are both safe and effective for their intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Jo S.C. Lee Ouality Assurance Engineer Thunder Tiger Corporation No. 7, 6th Road Industry Park Taichung China (Taiwan) R.O.C. 40755

APR 2 7 2011

Re: K102517

Trade/Device Name: Tiger 500 Series High Speed Handpieces and Attachments Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece Accessories Regulatory Class: I Product Code: EFB Dated: April 19, 2011 Received: April 21, 2011

Dear Mr. Lee:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Lee

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 (OS) 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/ucm l 15809.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/Safety/ReportaProblem/ 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh 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

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for Thunder Tiger. The logo consists of a circle with an airplane inside of it on the left, and the words "Thunder Tiger" on the right. The word "Thunder" is on top of the word "Tiger", and there is a line above the word "Tiger".

、

THUNDER TIGER CORP. NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23591616 FAX : 886-4-23591902 E-mail: tt@thundertiger.com http://www.thundertiger.com

Indications for Use

510(K) Number (If Known): ____________________________________________________________________________________________________________________________________________________

Device Name: Tiger 500 Series High Speed Handpieces and Attachments Indications for Use:

Over-The-Counter Use_ AND/OR Prescription Use_ X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH Office of Device Evaluation (ODE)
BSBetz DDS for Dr Susan Renner
(Division Sign-Off)
Division of Anesthesiology, General HospitalInfection Control, Dental Devices
510(k) Number:	K102517

age 4-1

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.