The A-dec NLZ electric motor system is control unit that drives a direct current (DC) electric micromotor that is activated by means of a foot control. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, prophylaxis and endodontic treatment, with use of a straight, right-angle ISO E-tvpe handpiece attachment of equal, gear-reducing, or gear-increasing speed.

Device Description

The A-dec NLZ electric motor system is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed.

Control Unit, Motor and Motor Tubing are constituents of the A-dec NLZ electric motor system under this 510(k) application. The A-dec NLZ electric motor system is intended for use only with the A-dec 300 (K082985) or A-dec 500 (K032756) delivery system. The A-dec 300 (K082985) or A-dec 500 (K032756) delivery system offers operation modes for use with the A-dec NLZ electric motor system.

The Control Unit of the A-dec NLZ electric motor system is contained within the control head of the A-dec 300 (K082985) or A-dec 500 (K032756). The subject device acquires +24 VAC electrical power from the delivery system to the Control Unit. User can control the motor system through Touch Pad and Foot Controller of the delivery system. The control unit receives instructions such as motor rotation/stop, speed setting value, torque setting value, and LED turning ON/OFF from Touch Pad and Foot Controller. The Control Unit drives the Motor using instructed rotation speed and torque via Motor Tubing. The delivery system provides standard mode (range of rotation speed is 1,000 - 40,000 rpm) and endo mode (range of rotation speed is 100 - 5,000 rpm).

The Motor Tubing is connected to the Control Unit via a lead wire and air/water supply via tubing inside the control head of the delivery system. The other side of the Motor Tubing is attached to the Motor.

AI/ML Overview

The provided document is a 510(k) summary for the A-dec NLZ Electric Motor System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the level of detail typically required to answer your specific questions regarding acceptance criteria and a detailed study proving performance, especially in the context of AI/ML devices or studies involving human readers and ground truth.

This document describes a traditional dental device (electric motor system), not an AI/ML device. Therefore, many of your questions, particularly those about AI/ML specific details like training sets, ground truth establishment for training data, MRMC studies, or standalone algorithm performance, are not applicable to the information provided.

Based on the available information, here's what can be extracted and what cannot:

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

The document states that the device was compliant with ISO 14457 and met the requirements of other standards. However, it does not provide a table with specific acceptance criteria (e.g., numerical thresholds for different performance metrics) and corresponding reported performance values for those criteria. It only provides a comparison table of features and ranges with the predicate device.

Feature	Acceptance Criteria (Implied by standard compliance)	Reported Device Performance (A-dec NLZ Electric Motor System)
Bench Testing	Conformity to ISO 14457	All samples compliant with ISO 14457
Electrical Safety	Conformity to IEC 60601-1	Test results indicate no concern
EMC	Conformity to IEC 60601-1-2	Test results indicate no concern
Biocompatibility	Conformity to ISO 10993-5, -10	No biocompatibility concern raised
Sterilization	Conformity to FDA guidance	Performed in accordance with FDA guidance
Software Validation	Conformity to FDA guidance	Conducted in accordance with FDA guidance
Backflow (Motor Tubing)	No backflow into Motor/Motor tubing	No backflow detected
Extractables (Water Circuit)	No extractables/leachables detected	Extractables/leachables not detected
Ranges (compared to predicate, not acceptance criteria)
Standard Mode Rotation Speed	1,000 - 40,000 rpm (Predicate: 1,000 - 40,000 rpm)	1,000 - 40,000 rpm
Endo Mode Rotation Speed	100 - 5,000 rpm (Predicate: 100 - 5,000 rpm)	100 - 5,000 rpm
Standard Mode Max Torque	- (Predicate: 4.10 Ncm)	4.00 Ncm (Measured value)
Endo Mode Torque Range	0.30 - 3.00 Ncm (Predicate: 0.30 - 3.00 Ncm)	0.30 - 3.00 Ncm

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

The document mentions "All A-dec NLZ electric motor system samples" for bench testing but does not specify a numerical sample size. It refers to "samples" being compliant, but no specific count is provided. There is no information about data provenance as this is a device performance test, not a data-driven clinical study.

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

Not applicable. This device is not an AI/ML product that would require expert-established ground truth for a test set in the same way. The "ground truth" for this device's performance would be objective measurements against engineering and safety standards.

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

Not applicable. This concept applies to human expert review for establishing ground truth, which is not relevant here.

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 is not an AI-assisted device. No MRMC study was mentioned or implied.

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

Not applicable. This is not an algorithm, but a physical electric motor system.

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

For the performance tests mentioned (bench testing, electrical safety, EMC, biocompatibility, backflow, extractables), the "ground truth" is established by the specified international and national standards (e.g., ISO 14457, IEC 60601-1, IEC 60601-1-2, ISO 10993 series) and FDA guidance documents. Compliance is determined by objective measurements meeting the criteria set forth in these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that uses a "training set."

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

Not applicable. This is not an AI/ML device.

Summary

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

May 11, 2017

Nakanishi, Inc. % Izumi Maruo Senior Consultant MIC International Corp. 4-1-17 Hongo Bunkyo-ku, Tokyo 1130033 JAPAN

Re: K163131

Trade/Device Name: A-dec NLZ Electric Motor System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EBW Dated: April 24, 2017 Received: April 25, 2017

Dear Izumi Maruo:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael J. Ryan -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) K163131

Device Name A-dec NLZ electric motor system

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Owner/Company name, address a. NAKANISHI INC. 700 Shimohinata, Kanuma-shi, Tochigi, 322-8666, Japan

b. Contact

Kimihiko Satoh General Manager, Regulatory Affairs Department NAKANISHI INC. 700 Shimohinata, Kanuma-shi, Tochigi, 322-8666, Japan

+81-289-64-4325 Phone: Fax: --+81-289-62-6665 k-satoh@nsk-nakanishi.co.jp Email:

c. Application Correspondent

Izumi Maruo Senior Consultant MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan

Phone: +81-3-3818-8577 Fax: +81-3-3818-8573 maruo@mici.co.jp Email:

d. Date prepared

May 10, 2017

e. Name of device

Trade Name: Classification Name: Regulation Name: Regulatory Class: Product Code:

A-dec NLZ Electric Motor System Controller, Foot, Handpiece and Cord Dental handpiece and accessories Class I EBW

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f. Predicate devices

The A-dec NLZ electric motor system is substantially equivalent to the following legally marketed device:

510(k): K133776 A-dec/W&H Electric Motor, Model EA-53 Trade name: Product code: EBW

g. Description of the device

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h. Indications for Use

The A-dec NLZ electric motor system is comprised of a control unit that drives a direct current (DC) electric micromotor that is activated by means of a foot control. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed.

i. Statement of substantial equivalence

The Indications for Use of the A-dec NLZ electric motor system is similar to the predicate. Other features of the subject device are similar to the predicate.

Following table is comparison between the A-dec NLZ electric motor system and the predicate.

	A-dec NLZ electric motorsystem	A-dec/W&H Electric Motor,Model EA-53 (K133776)
Indications for Use	The A-dec NLZ electric motor system is comprised of a control unit that drives a direct current (DC) electric micromotor that is activated by means of a foot control. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed.	The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a DC electric micromotor that is activated by means of a footswitch. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis, and endodontic treatment, with use of a straight, right- angle, or contra-angle ISO E-type handpiece attachment of equal speed, gear-reduction speed, or gear-increasing speed.
Drive	Electronic-micromotor	Electronic-micromotor
Components	Motor controller, Electric micromotor, Motor tubing	Motor controller, Electric micromotor, Motor tubing
Size
-Motor controller	D78.5 x W148.0 x H43.0(Protruding parts not included.)	D60 x W120 x H44(Protruding parts not included.)

Table 1. Comparison table between the A-dec NLZ electric motor system and the predicate

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-Motor	Length : 31 mmDiameter : Φ20.1(Front)Φ22.1(Rear)	Length : 31 mmDiameter : Φ20.7(Front)Φ21.3(Rear)
-Motor tubing	Length of tubingNLZ CDAS: 1600 mmNLZ CDAL: 2080 mm	Length of tubing2080 mm
Material of Motor exterior	Titanium	Stainless steel
Light	LED	LED
Range of rotation speed (rpm) (standard mode)	1,000 - 40,000 rpm	1,000 - 40,000 rpm
Range of rotation speed (rpm) (endo mode)	100 – 5,000 rpm	100 - 5,000 rpm
Rotating direction	Forward and Reverse	Forward and Reverse
Torque- Standard Mode Maximum Torque (Stall Torque)	4.00 Ncm (Measured value)	4.10 Ncm (Measured value)
- Endo Mode Torque Range	0.30 - 3.00 Ncm	0.30 - 3.00 Ncm
Coolant mechanism	Coolant air	Coolant air
Sterilization	Sterilized by user(steam sterilization)	Sterilized by user(steam sterilization)
Available Handpiece type	E-type (ISO3964)	E-type (ISO3964)
Usage environment	Temperature : 0 - 40°CHumidity : 30 - 75% RH	Temperature : 10 - 33 ℃

In the comparison table, there are some differences in characteristics between the A-dec NLZ electric motor system and the predicate. We considered that the differences did not affect the identical principles of operation between the A-dec NLZ electric motor system and the predicate. Performance testing including biocompatibility testing, Electric safety and EMC testing, bench testing was performed in order to demonstrate substantial equivalence to the predicate. Also, sterilization and software validation were performed in accordance with FDA guidance. The A-dec NLZ electric motor system met all requirements of the standards. Therefore, the A-dec NLZ electric motor system demonstrated substantial equivalence to the predicate.

j. Biocompatibility

Following biocompatibility test was performed:

. Cytotoxicity (ISO 10993-5:2009)
Sensitization (ISO 10993-10: 2010)

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Irritation (ISO 10993-10: 2010) .

In the biocompatibility testing reports, no biocompatibility concern was raised.

k. Bench Testing

The bench tests were performed in order to verify conformity to ISO 14457.

All A-dec NLZ electric motor system samples were compliant with ISO 14457.

Also, electromagnetic compatibility testing in accordance with IEC 60601-1-2 and electrical safety testing in accordance with IEC 60601-1 were performed. Those test results indicate that the A-dec NLZ electric motor system does not raise concern.

Software validation was conducted in accordance with FDA guidance entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices -Guidance for Industry and FDA Staff, May 2005" and sterilization of the Motor was conducted in accordance with FDA guidance entitled "Reprocessing Medical Devices in Health Care Settings: Validation Method and Labeling Guidance for Industry and Food and Drug Administration Staff". In addition, infection/cross-contamination risk analysis of the Motor tubing in accordance with ISO14971 was conducted. Based on the risk analysis, verification testing was performed in order to evaluate the possible introduction of biological materials (e.g. blood, bone, saliva) into the Motor tubing due to backflow. No backflow into the Motor and Motor tubing was detected in the verification testing.

In order to evaluate extractables of the water circuit of the subject device, the elution testing was performed. The extractables/leachables were not detected.

No animal or clinical testing was performed.

l. Conclusion

The indications for use of the A-dec NLZ electric motor system is similar to the predicate. Although there are some differences in characteristics between the A-dec NLZ electric motor system and the predicate, a number of performance testing indicated that the A-dec NLZ electric motor system met the requirement of the standards. Based on above results, we conclude the A-dec NLZ electric motor system is substantially equivalent to the predicate.

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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.