ELEC Master & ELEC Master Dual are 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.

Device Description

This product consists of a micro motor controller and display panel. Receiving rated input of AC 24V, this device controls motor speed, and rotation direction through the motor control circuit inside the controller. Motor speed, light and rotation direction functions can be set on the display panel.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a dental handpiece and accessories called "ELEC Master" and "ELEC Master Dual" by MGNEWTON Ltd. It's a regulatory document demonstrating substantial equivalence to a predicate device, not a detailed study report. Therefore, most of the requested information regarding acceptance criteria and performance studies is not explicitly provided in the typical format of a medical device performance study report.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

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

The document does not provide a table of acceptance criteria and reported device performance in the sense of accuracy, sensitivity, specificity, or other clinical performance metrics that would be associated with a diagnostic or treatment guidance AI device.

Instead, the "acceptance criteria" here relate to conformity with established standards for dental handpieces and electrical safety, and substantial equivalence to a predicate device. The "reported device performance" is essentially that the device complies with these standards and has equivalent specifications to the predicate.

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance (Compliance/Equivalence)
Indications for Use (Substantial Equivalence)	Matches the indications for use of the predicate device (A-dec NLZ electric motor system).	"ELEC Master & ELEC Master Dual are 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." This is reported as "Substantially Equivalent" to the predicate's indications.
Technological Characteristics (Substantial Equivalence)	Similar drive, device components, light, range of rotation speed, rotation direction, and max torque as the predicate device. Differences in spray air/water pressure are deemed not to raise new questions of safety/effectiveness.	The device's drive, components, light, rotation speed, rotation direction, and max torque are all listed as "Substantially Equivalent." Differences in spray air pressure (44 psi vs 29 psi) and spray water pressure (22 psi vs 29 psi) were identified but deemed acceptable as "optional features" not affecting substantial equivalence.
Standards Conformance	Compliance with specific ISO and IEC standards for dental handpiece coupling, general dental unit requirements, handpieces and motors, electrical safety, EMC, basic safety and essential performance of dental equipment, and usability engineering.	Non-clinical bench tests were performed to ISO 3964, ISO 7494-1, ISO 14457, IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, and IEC 62366. It's stated that "None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazard."
Sterilization Validation	Validation of the sterilization method.	"sterilization validation... were also conducted." (No specific details of the validation or specific acceptance criteria provided here, but it implies successful validation.)
Software Validation	Validation of the device's software.	"...software validation were also conducted." (No specific details of the validation or specific acceptance criteria provided here, but it implies successful validation.)

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

This document describes non-clinical bench tests (performance tests, electrical safety, EMC, sterilization validation, software validation) against recognized standards and a comparison of technical specifications to a predicate device. It does not involve a study with a test set of human subjects or patient data in the way an AI diagnostic device would. Therefore, sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in this context. The "test set" here refers to the actual device prototypes undergoing the specified bench tests.

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 section is not applicable. The "ground truth" for this type of device is established by adherence to engineering specifications and international standards (e.g., maximum torque defined by a standard, electrical safety requirements). These are objective measurements against predefined criteria, not subjective interpretations requiring expert consensus.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth from expert interpretations (e.g., radiologists reading images) where disagreement might occur. For objective bench tests and compliance with engineering standards, no such adjudication is needed.

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 section is not applicable. This device is a dental handpiece motor system, not an AI-powered diagnostic or treatment assistance tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this submission.

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

This section is not applicable. The device is not an algorithm or AI system. Its performance is evaluated through its physical and electrical characteristics as determined by bench testing against established standards.

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

The "ground truth" in this context is the compliance with predefined technical specifications and international consensus standards. For example, the "ground truth" for torque is the specified 3Ncm, and the test verifies that the device meets this. The "ground truth" for electrical safety is its conformity to IEC 60601-1.

8. The sample size for the training set

This section is not applicable. This is not an AI/machine learning device, so there is no training set.

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

This section is not applicable. As there is no training set, the establishment of ground truth for it is irrelevant.

Summary

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May 5, 2023

Mgnewton Ltd. % Priscilla Chung Official Correspondent LK Consulting Group USA, Inc. 1150 Roosevelt, Suite 200 Irvine, California 92620

Re: K202963

Trade/Device Name: ELEC Master, ELEC Master Dual Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EBW Dated: April 7, 2023 Received: April 7, 2023

Dear Priscilla Chung:

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,

Bobak Shirmohammadi -S

For Michael Adjodha, M.ChE.,COIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)

Device Name ELEC Master & ELEC Master Dual

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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510(k) Summary K202963

This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92

Date: SEP 29, 2020

1. 510K Applicant / Submitter:

MGNEWTON LTD. 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si, Gyeongsangbuk-do, Republic of Korea Tel: +82-53-214-6287 Fax: +82-70-7469-2074

2. Submission Contact Person

LK Consulting Group USA, Inc. 1150 ROOSEVELT, SUITE 200 Irvine , CA 92620 Priscilla Chung Phone: 714 2025789 Ext Email: Juhee.C(@)Lkconsultinggroup.com

3. Subject Device

-. Trade Name : ELEC Master & ELEC Master Dual
-. Classification Name : Controller, Foot, Handpiece and Cord
-. Regulation Number : 21 CFR 872.4200
-. Regulation Name : Dental handpiece and Accessories
-. Regulatory Class : I
-. Product Code : EBW

4. Predicate Device

-. Trade Name : A-dec NLZ electric motor system
-. 510(k) Number : K163131
-. Regulation Number : 21 CFR 872.4200
-. Regulation Name : Dental handpiece and Accessories
-. Regulatory Class : I
-. Product Code : EBW

5. Description:

Micromotor Model Name	ELEC Master	ELEC Master Dual
Optic(White LED)	O	O
Torque	Max. 3Ncm	Max. 3Ncm
Number of motor(EML40W)	1	2
RPM(Gear 1: 1)	Max. 40,000	Max. 40,000

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Direction	Clock / counter clock	Clock / counter clock
-----------	-----------------------	-----------------------

6. Indications for Use

7. Substantial Equivalence Discussion:

The subject device is substantially equivalent to A-dec NLZ electric motor system (K163131). The subject device has the same indications for use and the technological characteristics as the predicate device. It also has the equivalent specifications as the predicate device in almost all parameters. The major difference is spray air pressure & spray water pressure. However this differences do not raise a question in substantial equivalence discussion since the user can use water and air spray hoses that are usually provided on a dental chair in the dental office. Since these are optional features, we believe these differences do not raise a new question in safety and effectiveness. Based on the performance test data, we conclude that the subject device is substantially equivalent to the predicate device.

	Candidate Device	Predicate 1	Comparison
510(k) Number	K202963	K163131	-
Device Name	ELEC MasterELEC Master Dual	A-dec NLZ electric motorsystem	-
Manufacturer	MGNEWTON Ltd.	NAKANISHI INC.	-
Indications for Use	ELEC Master &ELEC Master Dualare intended for use ingeneral dentalapplications such as:cutting a tooth forcavity preparation,crown preparation,crown finishing, inlay,filing, polishing,prophylaxis andendodontic treatment.	A-dec NLZ electric motorsystem is intended for usein general dentalapplications such as:cutting a tooth for cavitypreparation, crownpreparation, crownfinishing, inlay, filing,polishing, prophylaxis andendodontic treatment.	SubstantiallyEquivalent
Drive	Electronic-micromotor	Electronic-micromotor	SubstantiallyEquivalent
Device components	Control unit with hoseand electrical motor	Control unit with hose andelectrical motor	SubstantiallyEquivalent
Light (Motor LED)	Yes	Yes	SubstantiallyEquivalent
Range of rotation speed	1,000-40,000 rpm	1,000- 40,000 rpm	SubstantiallyEquivalent
Rotation Direction	Forward and Reverse	Forward and Reverse	SubstantiallyEquivalent
Max. Torque	3Ncm	3Ncm	SubstantiallyEquivalent
Spray Air Pressure	44 psi (0.3 MPa)	29psi (0.2 MPa)	Different #1
Spray Water Pressure	22 psi (0.15 MPa)	29psi (0.2 MPa)	Different #2
Coolant mechanism	Coolant air	Coolant air	SubstantiallyEquivalent

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Sterilization	Sterilized by user(Steam Sterilization)	Sterilized by user(Steam Sterilization)	SubstantiallyEquivalent
Conformance withstandards for shanks(Available HandpieceType)	E-typeComply withISO 3964	E-typeComply withISO 3964	SubstantiallyEquivalent

8. Performance Tests (Non-clinical)

Non-clinical bench tests were performed as followings:

ISO 3964:2016 Dental Handpieces Coupling dimensions
ISO 7494-1:2011 Dentistry Dental units -Part 1: General requirements and test methods
ISO 14457:2017 Dentistry Handpieces and motors
IEC 60601-1, IEC 60601-1-2: Electrical safety and EMC
IEC80601-2-60:2012 : Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment
IEC 62366 : Application of usability engineering to medical devices
Along with the above tests, sterilization validation, and software validation were also conducted. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazard.

9. Conclusions:

Based on the information provided in this premarket notification, MGNEWTON Ltd. concludes that the ELEC Master & ELEC Master Dual are substantially equivalent to the predicate device as described herein in safety and effectiveness.

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.