The Ti-Max X450 is an air-powered dental handpiece with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used.

The. Ti-Max X450 is intended for use with a friction grip bur that conforms to ISO 1797-1 standard. Recommended supply air pressure is between 0.22 and 0.30 MPa, which results in high-speed bur rotation (approximately 380,000 to 450,000 RPM).

Device Description

The Ti-Max X450 air-powered high-speed dental handpiece capable of reaching rotational speeds of 380,000 to 450,000 revolutions per minute. The device includes non-optic, fiber-optic, and LED models. All models have a 45 degree back angle. Models are available to connect directly to the couplings of specific brands.

AI/ML Overview

The provided text describes a 510(k) summary for a dental handpiece, the Ti-Max X450, and mentions its conformance with technical standards and internal specifications through bench testing. However, it does not include specific acceptance criteria, detailed study data, or information about AI/algorithm performance.

Therefore, many of the requested sections about acceptance criteria, study details, expert involvement, and AI performance cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Rotational Speed	380,000 to 450,000 RPM (when provided with 0.22 to 0.30 MPa supply air pressure)
Torque	At least 0.09 Ncm (at 0.22 to 0.30 MPa supply air pressure)
Noise Level	80 dBA or less
Back Angle	45 degrees
Water Jet Function	Includes a water jet directed to the bur point
Coupling System	One-touch quick connect; direct connection to 4- and 5-hole connections (ISO 9168); swivel adapter for 4-, 3-, and 2-hole connections (ISO 9168, type 2)
Bur Compatibility	Intended for use with a friction grip bur conforming to ISO 1797-1 standard

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not explicitly stated. The document mentions "bench testing" but does not provide details on sample size or data provenance. The submitter is Nakanishi, Inc. from Japan.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not explicitly stated. This device is a dental handpiece, not an AI or diagnostic device that requires expert ground truth for its performance evaluation in this context. Performance is based on physical characteristics and standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not explicitly stated. Adjudication methods are typically relevant for diagnostic or AI studies involving human interpretation. This document describes physical device performance.

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

No. This document is for a dental handpiece, not an AI or diagnostic device. There is no mention of MRMC studies or AI assistance.

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

No. This document is for a dental handpiece, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the AI/diagnostic sense. The "ground truth" for this device's performance is established by technical standards and internal specifications (e.g., ISO 1797-1, ISO 9168) and directly measured physical properties (RPM, torque, dBA).

8. The sample size for the training set

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

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

Not applicable. As above, no training set for an AI model is involved.

Summary

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5. 510(k) SUMMARY

Submitter:	Nakanishi, Inc.700 ShimohinataKanuma-Shi, Tochigi-Ken Japan 322-8666JUN 20 2012
Contact Person:	Mr. Toshihiko ShinozakiAssistant Manager, Technical Affairs DepartmentTEL: 0289(62)6011FAX: 0289(62)6665t-shinozaki@nsk-nakanishi.co.jp
Date Prepared:	July 7, 2011 (Revised June 18, 2012)
Trade Name:	Ti-Max X450
Common Name:	High Speed Air Turbine Handpiece
Classification Name:	EFB 872.4200 Handpiece, Air-Powered, Dental
Predicate Device:	K952927 - Palisades Dental, Impact Air 45 HandpieceK101717 - Aerobine, Inc., Air Powered Dental Handpiece [Karam45, Dexor45]
Device Description:	The Ti-Max X450 air-powered high-speed dental handpiece capable of reachingrotational speeds of 380,000 to 450,000 revolutions per minute. The device includesnon-optic, fiber-optic, and LED models. All models have a 45 degree back angle.Models are available to connect directly to the couplings of specific brands.
Statement ofIntended Use:	The Ti-Max X450 is an air-powered dental handpiece with intended use of being asurgical tool for impacted third molar removal and periodontal procedures forwhich a conventional handpiece would be used.
	The Ti-Max X450 is intended for use with a friction grip bur that conforms to ISO1797-1 standard. Recommended supply air pressure is between 0.22 and 0.30 MPa,which results in high-speed bur rotation (approximately 380,000 to 450,000 RPM).
Summary ofTechnologicalCharacteristics:	The Ti-Max X450 is capable of achieving high-speed rotation of 380,000 to450,000 revolutions per minute when provided with a supply air pressure of 0.22 to0.30 MPa (32 - 44 psi). This provides a torque of at least 0.09Ncm, whilegenerating a noise level of 80dBA or less. The Ti-Max X450 has a 45 degree backangle. Also available are models with fiber optic or LED lighting. All modelsinclude a water jet that is directed to the bur point.
	The Ti-Max X450 has a one-touch quick connect coupling system. The Ti-MaxX450 can connect directly to the dental unit, or a swivel adapter can be used. Directconnection can be made with 4- and 5-hole connections that meet ISO 9168specifications. A swivel adapter is connected between the handpiece and hose in thecase of 4-, 3-, and 2-hole connections, also in compliance with ISO 9168, type 2. Inaddition, the Ti-Max X450 has models available that are designed to connectdirectly to the couplings of other brands.

NAKANISHI INC.
www.nsk-inc.com

ﺎ.

Section 5: Page 1 of 2 Headquarters : 700 Shimohihata Kanuma-shi Tochigi 322-8666, Japan Tokyo Office : MY Building 1-13-3 Ueno Taito-ku Tokyo 110-0005, Japan

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11:33:33

KIJDO24

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The Ti-Max X450 was developed and is produced under consideration of all Performance applicable technical standards, internal specifications, and FDA guidance Testing: documents. The product's conformance with applicable international and internal standards was verified in the course of bench testing. Nakanishi considers the Ti-Max X450 to be substantially equivalent to the predicate Conclusion:

devices listed above. This conclusion is based on the similarities in intended use, principles of operation, functional design, and established medical use, and demonstrates that the Ti-Max X450 is substantially equivalent to the declared predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

JUN 2 0 2012

Nakanishi, Incorporated C/O Ms. Diane Rutherford Regulatory Engineer Ken Block Consulting 1201 Richardson Drive, Suite 280 Richardson, Texas 75080

Re: K112024

Trade/Device Name: Ti-Max X450 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: June 4, 2012 Received: June 12, 2012

Dear Ms. Rutherford:

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- Rutherford

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/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 yours,

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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INDICATIONS FOR USE

510(k) Number:

Device Name: Ti-Max X450

Indications for Use:

. .

Prescription Use X (21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

K112024

Page 1 of 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.