The EVO 450 series is the air-powered dental handpiece which is used by trained dental professionals for removal of carious material, cavities, crown preparations and as a surgical tool for impacted third molar removal and periodontal procedures.

Device Description

The EVO 450 series High Speed Handpieces 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, ergonomically shaped, and are provided both with and without a fiber optic light system. Several models could be connected to couplings of manufacturers including TTBIO, KaVo, NSK Mach, Sirona, and Star. Others could be connected to hose connectors type 2 or type 3 according to ISO 9168:2009 Dental handpieces-Hose connectors for air driven dental handpieces. The EVO 450 series High Speed Handpieces will be supplied with water, air and light through the tube and the coupling of a dental treatment unit. For proper operation, make sure that the supply of cooling air is dry, clean and uncontaminated. Make sure that air is not emitted in the direction of the bur. After each patient use, disinfect the tubing waterlines including the handpiece waterlines by flushing with cleaning water to prevent cross-contamination according to handpiece waterlines disinfection procedure of main dental unit.

AI/ML Overview

This looks like a submission for a 510(k) premarket notification for a medical device. The document states that the EVO 450 series High Speed Handpieces are substantially equivalent to the predicate device, Maxima PRO2 45L (K141576). It does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria in the format you requested, specifically regarding AI/algorithm performance.

The provided document describes a medical device (dental handpiece), not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study proving the device meets the acceptance criteria" as typically applied to AI/ML devices (e.g., performance metrics like sensitivity, specificity, AUC compared to a pre-defined threshold) is not present here.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device, which is the regulatory pathway for this type of medical device. This involves comparing the new device to a legally marketed predicate device in terms of:

Intended Use: Both devices are high-speed, air-powered dental handpieces for specific dental procedures.
Technological Characteristics: Comparison of physical attributes, materials, operating principles, and performance specifications.
Safety and Effectiveness: Demonstrated through compliance with recognized standards and non-clinical testing.

Here's an analysis of the provided information in relation to your questions, noting the context of a non-AI medical device:

A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criteria here are that the proposed device (EVO 450 series) is substantially equivalent to the predicate device (Maxima PRO2 45L) in terms of safety and effectiveness, based on similar intended use and technological characteristics. This is demonstrated through direct comparison and adherence to standards.
Reported Device Performance: The "Summary Table of Substantial Equivalence" on pages 4 and 5 directly compares the proposed device's characteristics against the predicate device. This serves as the reported performance, showing that the device's specifications (e.g., speed, operation pressure, materials) are comparable or within acceptable ranges relative to the predicate and relevant standards.

Table of Comparison (derived from the document):

Descriptive Information	Proposed Device (EVO 450 series)	Predicate Device (Maxima PRO2 45L K141576)	Comparison/Comment
Indication for use	Removal of carious material, cavities, crown preparations, surgical tool for impacted third molar removal and periodontal procedures.	Removal of carious material, cavities and crown preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures.	Substantially similar.
Principle of operation	Air-powered turbine, cooling water, optional light system.	Air-powered turbine, cooling water, light system.	Identical mechanism.
Water ports	Four	One	Differs but does not raise new safety or effectiveness questions.
Fiber optics	With and without fiber-optic glass rod built-in light system	With built-in light system	Option for both, similar technology.
Light intensity on input side	N/A	Approx. 25000 Lux	Not directly comparable, but presence of light system is noted.
Head Dimensions	Φ10.5×H12.5mm	Φ12.5×H14.6mm	Slight dimensional difference, but within a functional range.
Type of chuck	Push button locking chuck	Identical	Identical.
Materials of body of the device	Stainless steel	Stainless steel	Identical.
Bur retention force	Up to 24 N-cm	Identical	Identical (implied, as no difference noted).
Operation pressure	2.0-3.0 bar	2.75±0.1 bar	Overlapping range.
Speed	360,000~440,000 rpm	380,000~420,000 rpm	Overlapping range.
Conformance with standards for shank	Ø1.59mm~1.60 mm	Identical	Identical (implied, as no difference noted).
Head angle	45-degree	Identical	Identical.
Compliance to Standards	ISO 14457:2017, ISO 9168:2009	ISO 14457:2012, ISO 9168:2009	Both comply with relevant standards (new device with updated version for one).
Sterilization Method	Steam Autoclave (Moist Heat)	Steam Autoclave (Moist Heat)	Identical.
Sterilization Standard	ISO 17665-1:2006	ISO 17665-1:2006	Identical.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not applicable and not provided in the context of a 510(k) submission for this type of device. The "testing" refers to non-clinical bench testing and adherence to standards, not a patient-based test set or clinical trial data collection.
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. This device is not an AI/ML diagnostic tool requiring expert ground truth for image or data interpretation. Performance is assessed through engineering specifications and compliance with standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" in the sense of clinical cases or data requiring adjudication.
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 document is for a dental handpiece, not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is not an AI/ML algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of an AI/ML algorithm. For this device, "ground truth" relates to engineering specifications verified through testing and adherence to established industry standards (e.g., ISO for dental handpieces, sterilization, biocompatibility).
The sample size for the training set
- Not applicable, as this is not an AI/ML algorithm development.
How the ground truth for the training set was established
- Not applicable, as this is not an AI/ML algorithm development.

In summary: The provided document is a 510(k) summary for a conventional medical device (a dental handpiece). It focuses on demonstrating substantial equivalence to a predicate device through comparison of features and adherence to non-clinical performance standards. It does not involve AI/ML technology, and therefore, the questions related to AI/ML specific acceptance criteria, study design, and ground truth establishment are not addressed or applicable in this context.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 11, 2019

Ttbio Corp. Shu-Ching Lee Section Chief 2F, No.7, 6th Road Industry Park Taichung, 40755 TAIWAN

Re: K190508

Trade/Device Name: EVO 450 series High Speed Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: November 11, 2019 Received: November 13, 2019

Dear Shu-Ching 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K190508

Device Name EVO 450 series High speed Handpieces

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for "TT BIO". The logo consists of two stylized "T" letters connected together, followed by the word "BIO" in a simple sans-serif font. The entire logo is in a light gray color. The logo appears to be for a biotechnology company.

TTBIO CORP. 2F, NO.7, 6* ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196

510(K) SUMMARY-K190508

EVO 450 series High Speed Handpieces

1. Date Prepared: December 10,2019

Submitter Information 510(k) Owner: TTBIO CORP. 2F, No.7, 6th Road, Industry Park, Taichung, Taiwan, R.O.C. 40755 Contact Person: Shu-Ching Lee/Section Chief Phone: 886-4-23595958/email: jo@ttbio.com

1. Device Name
  Trade Name: EVO 450 series High Speed Handpieces Common Name: Dental Handpiece Classification Name: Dental Handpiece and Accessories (21 CFR 872.4200, Product Code EFB)
1. Predicate Device: Maxima PRO2 45L made by Kaltenbach & Voigt GmbH (K141576)
1. Device Description:

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TTBIO CORP. 2F, NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196

Further one there is a nozzle cleaner needle supplied with the EVO 450 series High Speed Handpiece. If spray nozzle is blocked with debris clean the spray nozzle with the nozzle cleaner needle.

1. Intended Use:
  The EVO 450 series is the air-powered dental handpiece which is used by trained dental professionals for removal of carious material, cavities, crown preparations and as a surgical tool for impacted third molar removal and periodontal procedures.
1. Substantial Equivalence
  The EVO 450 series High Speed Handpieces are the same as predicate device, Air-Powered handpieces, which intended for dentistry treatment and these devices are only for trained persons in the field of dentistry. The proposed devices are essentially identical or similar to the predicate device in terms of the design, principles of operation, technological characteristics and materials. The patient contact materials used are well-known biocompatible, so no new issues of biocompatibility are raised with regard to the proposed devices. Additionally, the proposed devices are complying with FDA recognized standards for High-Speed dental handpieces.

Summary Table of Substantial Equivalence
DescriptiveInformation	Proposed Device	Predicate Device
	EVO 450 series	Maxima PRO2 45L(K141576)
Indication foruse	The EVO 450 series is the air-powereddental handpiece which is used bytrained dental professionals forremoval of carious material, cavities,crown preparations and as a surgicaltool for impacted third molar removaland periodontal procedures.	This air-powered dental handpiece isintended for removal of cariousmaterial, cavities and crowpreparations, removal of filings,processing of tooth, restoration ofsurfaces and as a surgical tool forthird molar removal procedures.
Principle ofoperation	The coupling through the tubeconnected to a dental unit. Thedevices receive the air for the turbineto proceed the system usedair-powered technique. The coolingwater for cutting treatment. And partsof devices have a light system forillumination the operation area.	Through the tube and the couplingconnected to a dental unit, theair-powered handpiece receives theair for operating the high speedturbine, the cooling water for cuttingtreatment through one port and lightfor illumination the operation area.

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Image /page/5/Picture/0 description: The image shows a logo for a company called "TBIO". The logo consists of two stylized "T" shapes that are connected to the word "BIO". The logo is gray and has a modern, minimalist design. The logo is likely used to represent the company's brand and identity.

TTBIO CORP. 2F, NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196

Summary Table of Substantial Equivalence
DescriptiveInformation	Proposed Device	Predicate Device
	EVO 450 series	Maxima PRO2 45L(K141576)
Water ports	Four	One
Fiber optics	With and without fiber-optic glass rodbuilt-in light system	With built-in light system
Light intensityon input side	N/A	Approx. 25000 Lux
HeadDimensions	Φ10.5×H12.5mm	Φ12.5×H14.6mm
Type of chuck	Push button locking chuck	Identical
Materials ofbody of thedevice	Stainless steel	Stainless steel
Bur retentionforce	Up to 24 N-cm	Identical
Operationpressure	2.0-3.0 bar	2.75±0.1 bar
Speed	360,000~440,000 rpm	380,000~420,000 rpm
Conformance withstandards forshank	Ø1.59mm~1.60 mm	Identical
Head angle	45-degree	Identical
Compliance toStandards	ISO 14457:2017ISO 9168:2009	ISO 14457:2012ISO 9168:2009
SterilizationMethod	Steam Autoclave (Moist Heat)	Steam Autoclave (Moist Heat)
SterilizationStandard	ISO 17665-1:2006	ISO 17665-1:2006

1. Discussion of non-clinical data:
  The functions of EVO 450 series High Speed Handpieces were verified according to ISO14457:2017. Sterilization has been validated in conformance to the FDA recognized consensus standard ISO 17665-1:2006 Sterilization of health care products – moist heat – Part 1: requirements for the development, validation and routine control of a sterilization process for medical devices. Cleaning validation testing is performed in accordance with recommended evaluations as listed in AAMI TIR30, AAMI TIR12, and Guidance for Industry and FDA Staff -Processing/Reprocessing Medical Devices in Health Care Settings.

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Image /page/6/Picture/0 description: The image shows the logo for "TT BIO". The logo consists of two stylized "T" shapes that are connected to each other. To the right of the second "T" is the word "BIO" in a simple sans-serif font. The entire logo is in a light gray color.

TTBIO CORP. 2F, NO.7, 6* ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196

1. Discussion of Clinical Tests Performed: N/A
1. Conclusion:

The EVO 450 series High Speed Handpieces are substantially equivalent to the predicate device. They are same as the predicate device in terms of its intended use, operating principles and functions.

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.