The Concentrix MX-AC High-Speed Handpiece is used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.

Device Description

The Concentrix MX-AC High-Speed Handpiece is a pneumatically driven, non-fiber optic, 2/3 line fixed backend handpiece that is capable of reaching rotational speeds of 302,000 rpms at a recommended air pressure of 32 PSI. The handpiece is constructed of stainless steel, including the internal air and water tubes which provide drive air to the turbine assembly and cooling water to the work site. The stainless steel and aluminum air driven turbine assembly provides spin to the bur and incorporates steel lubricated bearings and a push button autochuck. The burs used with the Concentrix MX-AC High Speed Handpiece are ISO 1797-1, type 2 burs. Only burs with hardened, tempered steel shanks or carbide shanks should be used.

AI/ML Overview

This document is a 510(k) premarket notification for a dental handpiece, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and training sets for an AI/ML device is not applicable.

The document discusses the substantial equivalence of the Concentrix MX-AC High-Speed Handpiece to predicate devices. The "performance data" section outlines tests conducted to demonstrate functional performance and safety, but these are for the mechanical device itself, not an AI algorithm.

Here's a breakdown of the relevant information provided, while noting the requested AI-specific details are not present:

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

The document doesn't present a table with specific acceptance criteria and reported device performance in the way one might expect for a quantitative AI/ML study (e.g., sensitivity, specificity thresholds). Instead, it states that the device's functional performance and safety were evaluated against established international standards.

Acceptance Criteria (Implied by standards)	Reported Device Performance
Conformance to ISO 14457:2012 (Dentistry—Handpieces and Motors)	Test results confirm that the Concentrix MX-AC High-Speed Handpiece conforms to the requirements of ISO 14457:2012.
Conformance to ISO 60601-1:2005 (Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance)	Test results confirm that the Concentrix MX-AC High-Speed Handpiece conforms to the requirements of ISO 60601-1:2009.
Biocompatibility: Non-cytotoxic, non-sensitizing, and non-irritating (per ISO 10993-5, ISO 10993-10, ISO 10993-12, and FDA Guidance)	Biocompatibility tests (cytotoxicity, sensitization, irritation) indicate the device is non-cytotoxic, non-sensitizing, and non-irritating.
Sterilization validation (per ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009, and ANSI/AAMI ST81:2004 (R2010))	Sterilization validation for the handpiece (incorporating the turbine assembly) was performed in accordance with these standards.
Cleaning and disinfection validation (per FDA Guidance Document for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling")	Cleaning and disinfection validation was conducted per the FDA Guidance Document.
Risk Analysis (per ISO14971:2012 Medical devices - Application of risk management to medical devices)	A risk analysis for the Concentrix MX-AC High-Speed Handpiece was developed using ISO14971:2012. (This implies risks were identified and addressed to an acceptable level as per the standard, but specific findings are not detailed in this summary.)

2. Sample size 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. The performance data refers to physical testing of the device, not a data-driven test set for an algorithm.

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):

This is not applicable as there is no ground truth or expert review for an AI/ML device mentioned.

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

Not applicable.

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 as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

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

Not applicable. The "ground truth" for this device's performance would be the physical measurements and observations of its mechanical and biological characteristics as defined by the referenced ISO/AAMI standards.

8. The sample size for the training set:

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

In summary, the provided document is a 510(k) summary for a physical medical device (dental handpiece), not an AI/ML product. Therefore, the specific questions related to AI/ML device studies, ground truth, and data sets are not relevant to this document. The device meets its acceptance criteria by conforming to established international standards for physical, mechanical, and biocompatibility performance.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

March 28, 2018

DentalEZ, Inc. Kay Engle Regulatory Affairs/OA Supervisor 1816 Colonial Village Lane Lancaster, Pennsylvania 17601

Re: K173465

Trade/Device Name: Concentrix MX-AC High-Speed Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EFB Dated: February 26, 2018 Received: February 27, 2018

Dear Kay Engle:

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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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 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.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew I. Steen -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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 (if known) K173465

Device Name Concentrix MX-AC High-Speed Handpiece

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/1 description: The image contains the logo for DentalEZ, Inc., StarDental Division. The logo features a stylized graphic element with overlapping curved lines in shades of gray and green. To the right of the graphic is the text "DentalEZ" in a bold, sans-serif font, with the letters "IEZ" slightly smaller and in a different color. Below the logo is the text "DentalEZ, Inc., StarDental Division" in a smaller, sans-serif font.

Concentrix MX-AC High Speed Handpiece

510(k) Summary K173465

SUBMITTER l.

DentalEZ Inc., StarDental Division 1816 Colonial Village Lane Lancaster, PA 17601 Phone: (717) 291-1161 Fax: (717) 391-2757 Contact Person: Kay Engle, Regulatory Affairs/QA Supervisor Email: KEngle@ DentalEZ.com Rob Young, Senior Director of Engineering Email: RYoung@DentalEZ.com March 26, 2018

II. DEVICE

Name of the Device: Concentrix MX-AC High-Speed Handpiece Common or Usual Name: High-Speed Handpiece Air-Powered Classification Name: Dental Handpieces and Accessories Regulation Number: 21 C.F.R. § 872.4200 Regulatory Class: I Product Code: EFB

III. PREDICATE DEVICE

Primary Predicate: Concentrix High-Speed Handpiece Series - Concentrix MX, Concentrix PX Concentrix FX and Concentrix SX (K113301) as manufactured by StarDental Reference Device: Lube Free Autochuck Turbine with Vortex Air Seal for Use with StarDental 430 Series Lube Free High Speed Dental Handpieces (K982593)

IV. DEVICE DESCRIPTION:

The handpiece is constructed of stainless steel, including the internal air and water tubes which provide drive air to the turbine assembly and cooling water to the work site. The stainless steel and aluminum air driven turbine assembly provides spin to the bur and incorporates steel lubricated bearings and a push button autochuck.

The burs used with the Concentrix MX-AC High Speed Handpiece are ISO 1797-1, type 2 burs. Only burs with hardened, tempered steel shanks or carbide shanks should be used.

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V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

The Concentrix MX-AC High-Speed Handpiece and the predicate device have the sa me technologicalcharacteristics:

. Intended use
Method of operation
Use of the same base materials
Lubrication requirements
Autoclavable

The following technological differences exist between the Concentrix MX-AC High-Speed Handpiece and the predicate:

Autochuck turbine .
Free run speed
. End cap assembly

The proposed Concentrix MX-AC High-Speed Handpiece has the same technological similarities and differences as noted above for the primary predicate. The reference predicate uses a push button autochuck feature which is incorporated into the proposed device.

The difference between the proposed devices and the primary predicate device is the type of chucking mechanism used in the turbine assembly and the end cap assembly. These differences do not affect the performance of the device.

The following table summarizes the comparison of the proposed Concentrix MX-AC High-Speed Handpiece to the primary predicate and reference predicate for indications for use and technological characteristics.

Device	Proposed device:Concentrix MX-AC High-Speed Handpiece(K173465)	Primary Predicate:Concentrix High SpeedHandpiece Series-Concentrix MX,Concentrix PX,Concentrix FX andConcentrix SX (K113301)	Reference Device:Lube Free AutochuckTurbine with Vortex AirSeal for Use withStarDental 430 SeriesLube Free High SpeedDental Handpieces(K982593)
Indications forUse	The Concentrix MX-ACHigh-Speed Handpiece isused by trained dentalprofessionals for a varietyof procedures includingbut not limited to caries	The Concentrix High-Speed Handpieces areused by trained dentalprofessionals for a varietyof procedures includingbut not limited to caries	High-speed dentalhandpieces are usedintraorally by traineddental professionals fordrilling and preparationof dental caries for
Device	Proposed device:Concentrix MX-AC High-Speed Handpiece(K173465)	Primary Predicate:Concentrix High SpeedHandpiece Series-Concentrix MX,Concentrix PX,Concentrix FX andConcentrix SX (K113301)	Reference Device:Lube Free AutochuckTurbine with Vortex AirSeal for Use withStarDental 430 SeriesLube Free High SpeedDental Handpieces(K982593)
	and amalgam removal,restorative work andcrown preparations	and amalgam removal,restorative work andcrown preparations	restoration, such asfillings. Autochuckturbines are used in placeof a bur tool to facilitatebur changing.
Product Code	EFB	EFB	EFB
OperationalMode	Air driven	Air driven	Air driven
Type of chuck	Autochuck	Manual chuck:MX	Autochuck
OperatingPressure	32 PSI	32 PSI	Dependent on thehandpiece
Coupling Type	ISO 9168, Type 1	MX: ISO 9168, Type 1	N/A
Bur Dimension	ISO 1797-1, Type 2	ISO 1797-1, Type 2	ISO 1797-1, Type 2
Materialcomposition	Stainless steel	Stainless steel	Stainless steel
Components	High speed pneumaticdrivenHandpiece.Lubricated steel bearingautochuck turbineassemblyPushbutton end cap	High speed pneumaticdrivenHandpiece.Lubricated steel bearing,manual chuck turbineassemblySingle piece threaded endcap	Lube free ceramicautochuck turbineassemblyPushbutton end cap
Biocompatibility	Stainless steelSteel bearingsBiocompatibility testswere conducted inaccordance with therequirements of ISO10993-10 and ISO 10993-12. Test results indicatethe device is non-cytotoxic, non-sensitizingand non-irritating.	Stainless steelSteel bearings	Stainless steelCeramic bearings
Device	Proposed device:Concentrix MX-AC High-Speed Handpiece(K173465)	Primary Predicate:Concentrix High SpeedHandpiece Series-Concentrix MX,Concentrix PX,Concentrix FX andConcentrix SX (K113301)	Reference Device:Lube Free AutochuckTurbine with Vortex AirSeal for Use withStarDental 430 SeriesLube Free High SpeedDental Handpieces(K982593)
Sterilization	Sterilization validation inaccordance withANSI/AAMI ST79:2010 &A4:2013, AAMI/ANSI/ISO14937:2009 andANSI/AAMI ST81:2004(R2010)	Sterilization validation inaccordance withANSI/AAMI ST79:2010 &A4:2013, AAMI/ANSI/ISO14937:2009 andANSI/AAMI ST81:2004(R2010)	Sterilization validationreport references AAMITIR No. 12-1994
Performance	Variable 302,000 rpm+/- 10%	Variable 385,000 rpm+/- 10%	Variable 430,000 rpm,+/- 10%
Risk analysis	ISO14971:2012 Medicaldevices - Application ofrisk management tomedical devices	ISO14971:2000 Medicaldevices - Application ofrisk management tomedical devices	Risk Analysis at time ofsubmission unknown.Current risk analysis perISO 14971:2012 —Application of riskmanagement to medicaldevices

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VII. PERFORMANCE DATA

The following tests were conducted to evaluate the functional performance and safety the Concentrix MX-AC High-Speed Handpiece:

ISO 14457:2012 Dentistry— Handpieces and Motors
. ISO 60601-1:2005 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance

The test results confirm that the Concentrix MX-AC High-Speed Handpiece conforms to the requirements of ISO 14457:2012 and ISO 60601-1:2009 and is substantially equivalent for use as a high-speed handpiece.

Biocompatibility testing was conducted in accordance with Good Laboratory Practices regulations (FDA, 21 CFR, Part 58-Good Laboratory Practice for Nonclinical Laboratory Studies). ISO 10993-10 "Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization" and ISO 10993-12 "Biological Evaluation of Medical Devices, Part 12: Sample Preparation and Reference Materials" and the FDA Guidance Document "Use of International Stnadard ISO 10993-1, "Biological evaluation of medical devices – Part 11: Evaluation and testing within a risk management process", issued on June 16, 2016. Testing completed on this device includes:

. Cytotoxicity per ISO 10993-5
Sensitization per ISO 10993-10
. Irritation per ISO 10993-10

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Sterilization validation for the sterilization of the handpiece which incorporate the turbine assembly was performed in accordance to ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009 and ANSI/AAMI ST81:2004 (R2010).

Cleaning and disinfection validation was conducted per the FDA Guidance Document for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued on March 17, 2015.

A risk analysis for the Concentrix MX-AC High-Speed Handpiece was developed using ISO14971:2012.

VIII. CONCLUSION

Based upon the comparison of technological characteristics, demonstrated through bench testing and intended use, the Concentrix MX-AC High-Speed Handpiece is substantially equivalent to the predicate devices.

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.