The MK-dent® HS Handpiece shares virtually all specifications and design characteristics of the predicate devices. This was done intentionally by the designers and engineers. Only few minor changes implemented to the predicate device make the MKdent® Handpiece more convenient to use but do not affect the performance, safety or effectiveness of it.

AI/ML Overview

This document describes the 510(k) summary for the MK-dent® High Speed Dental Handpiece. It's important to note that this is a traditional 510(k) for a medical device (a dental handpiece), not an AI/ML device. Therefore, the questions regarding acceptance criteria, study design, ground truth, and expert evaluation typically associated with AI/ML performance studies are not directly applicable in the same way.

However, I can extract information related to how equivalency and safety/effectiveness are established for this type of device, which serves a similar function to "acceptance criteria" for traditional devices.

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

For traditional medical devices seeking 510(k) clearance, the "acceptance criteria" and "reported device performance" are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant voluntary standards. The reported device performance is implicit in its claim of substantial equivalence and compliance with these standards.

Acceptance Criteria (Demonstrated by)	Reported Device Performance (Claimed by Applicant)
Substantial Equivalence: Device shares virtually all specifications and design characteristics with predicate devices.	"In all respects, the MK-dent® Handpiece is substantially equivalent to one or more air-powered dental handpieces currently marketed in the USA."
Biocompatibility: Constructed of materials of the same specifications as the predicate device.	"The handpiece is constructed of materials of the same specifications as the predicate device to ensure biocompatibility."
Sterilization Efficacy: Ability to repeatedly adequately sterilize the device confirmed by validation protocol.	"The ability to repeatedly adequately sterilize the device has been confirmed by validation protocol."
Compliance with ISO Standards:	"The handpiece conforms to applicable ISO standards." Specifically:
- ISO Standard 7785-1: High speed dental turbines	(Implicitly meets by claiming overall ISO compliance)
- ISO Standard 1797: Shank dimensions	(Implicitly meets by claiming overall ISO compliance)
- ISO Standard 3964: Coupling device	(Implicitly meets by claiming overall ISO compliance)
- ISO Standard 27785: Sound level	(Implicitly meets by claiming overall ISO compliance)
- ISO Standard 27785: Water coolant	(Implicitly meets by claiming overall ISO compliance)
- ISO Standard 1797: Spindle strength	(Implicitly meets by claiming overall ISO compliance)

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 provided in the document. For traditional 510(k)s, there isn't typically a "test set" in the sense of a dataset processed by an algorithm. Instead, the device itself is tested to ensure compliance with standards and equivalence to predicates. The document doesn't detail any specific testing methodology or sample sizes for performance or safety testing beyond the statement regarding sterilization validation.

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 information is not applicable and therefore not provided. The concept of "ground truth" and expert review as applied to AI/ML performance is not relevant for this traditional dental handpiece 510(k) submission. Safety and effectiveness are demonstrated through adherence to engineering specifications and industry standards, and substantial equivalence to existing devices.

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

This information is not applicable and therefore not provided. Adjudication methods are relevant for expert review of data, which is not described in this submission.

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

This information is not applicable and therefore not provided. This is a traditional medical device, not an AI-powered one. MRMC studies are used to evaluate the impact of AI on human interpretation, which is not relevant here.

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

This information is not applicable and therefore not provided. This device is a manual dental handpiece and does not involve any algorithms.

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

This information is not applicable and therefore not provided. The "ground truth" for a dental handpiece's performance is its physical characteristics, material properties, and functionality as defined by engineering standards and demonstrated through testing, rather than a diagnostic or interpretive outcome requiring ground truth establishment.

8. The sample size for the training set

This information is not applicable and therefore not provided. As this is not an AI/ML device, there is no "training set."

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

This information is not applicable and therefore not provided. As this is not an AI/ML device, there is no "training set" or ground truth associated with it in this context.

Summary

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OCT - 2 2003 510(k) Summary of safety and effectiveness
Applicant:	MK-dent GmbHEichenweg 7B22941 Bargteheide, Germany	K032234
Contact:	Dr. Martina GünderothC.R.C. PartnerschaftsgesellschaftKatharinenstr. 523554 Lübeck, GermanyPhone: +49 (451) 388 2864 / Fax: +49 (451) 388 2867Email: crc@crc-online.de
Device Name:	MK-dent® High Speed Dental Handpiece, Models HS4021K,HS4011K, HS4012K, HS6021K, HS6011K, and HS6012K
Common Name:	Handpiece, air-powered, dental
Classification Name:	Dental handpiece
Device Class:	Class I
Product Code:	76 EFB
Code of Federal Regulations:	21 CFR 872.4200
Indications for Use:	The device is an air-powered dental handpiece providing lightthrough a glass optic rod for use by a trained professional ingeneral dentistry

Predicate Device Name: KaVo Dental Handpiece, Series 630 and 640 (K 760929) MK-dent® High Speed Dental Handpiece (K 021250)

Description of Device:

Substantially Equivalence - Safety and Effectiveness:

In all respects, the MK-dent® Handpiece is substantially equivalent to one or more airpowered dental handpieces currently marketed in the USA. The handpiece is constructed of materials of the same specifications as the predicate device to ensure biocompatibility. The handpiece conforms to applicable ISO standards. The ability to repeatedly adequately sterilize the device has been confirmed by validation protocol.

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Voluntary standard compliance:

ISO Standard 7785-1: High speed dental turbines
ISO Standard 1797: Shank dimensions
ISO Standard 3964: Coupling device
ISO Standard 27785: Sound level
ISO Standard 27785: Water coolant
ISO Standard 1797: Spindle strength

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three abstract shapes that resemble a stylized human figure or a bird in flight. The overall design is simple and recognizable, representing the department's mission and identity.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 2 2003

MK-Dent Gmbh C/O Dr. Martina Gunderoth C.R.C. Partherschaftsgesellschaft Katharinenstr. 5 23554 Lubeck, Germany

Re: K032234

Trade/Device Name: MK-Dent High Speed Dental Handpiece, Models HS4021k KS4011K, HS4012K, HS6021K, HS6011K, and HS6012K Regulation Number: 872.4200 Regulation Name: Dental handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: June 24, 2003 Received: July 21, 2003

Dear Dr. Gunderroth:

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 such additional controls. Existing major regulations affecting vour 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 - Dr. Gunderoth

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Susan Runner, DDS, MA Interim 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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3. Indications for Use

510(k) Number K032234

Device Name: MK-dent® High Speed Handpiece, Models HS 4021 K, HS 4011 K, HS 4012 K, HS 6021 K, HS 6011 K, and HS 6012 K

Indications for Use: The device is an air-powered dental handpiece providing light through a glass optic rod for use by a trained professional in general dentistry.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pein Muluy for MSR

510(k) Number. K 032234

Prescription Use OR (Per 21 CFR 801.109)

Over the Counter Use

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.