The device allows the relative position of a dental file and the apex to be determined electrically. Using a standard dental file inserted into the root canal as an electrode, the device emits very small electrical currents having frequencies of 400 Hz, and 10400 Hz. The current between the file and mouth is measured at each of these frequencies, and the readout of the relative proximity to the apex will appear on the meter.

AI/ML Overview

The Dr's Finder device is an apex locator "intended for detecting the apex of root canal."

Here's an analysis of its acceptance criteria and the study conducted to prove it:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance (Dr's Finder)
Accuracy	±0.2mm

2. Sample Size and Data Provenance:

The document mentions "comparison testing on Dr's Finder and the predicate device (RCM-7, K090925) was performed to compare the measurement performance of locating apex root using extracted tooth."

Sample Size: The exact number of extracted teeth used is not specified in the provided document.
Data Provenance: The study was conducted using extracted teeth, which implies a "non-clinical" setting. The country of origin for the data is not explicitly stated, but the manufacturer, "Good Doctors Co., Ltd.," is located in "Incheon, Republic of Korea."

3. Number of Experts and Qualifications:

The document does not specify the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method:

The adjudication method for establishing ground truth is not mentioned in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The study focused on comparing the performance of the device against a predicate device using test cases, not on human reader improvement with or without AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance study was conducted. The "comparison testing" on the Dr's Finder focused on its performance in locating the apex of root canals in extracted teeth, which is an evaluation of the algorithm/device's performance in isolation.

7. Type of Ground Truth Used:

The ground truth for the performance study was established by measurements on extracted teeth. The document does not elaborate on how this ground truth measurement was precisely determined (e.g., direct visual inspection, microscopic analysis, etc.), but it is implied to be a direct physical measurement.

8. Sample Size for Training Set:

The document does not mention a training set or its sample size. This suggests that the device's development might not have involved a typical machine learning training and testing paradigm as is common with some AI devices. It's more likely based on established electrical impedance principles.

9. How Ground Truth for Training Set Was Established:

Since no training set is mentioned, the method for establishing its ground truth is not applicable based on the provided information.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, layered on top of each other, with a flowing ribbon-like element extending from the bottom profile.

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

February 4, 2016

Good Doctors Co., Ltd. c/o Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 East Chapman Ave, Suite 110 Fullerton, California 92831

Re: K151274

Trade/Device Name: Dr's Finder Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LOY Dated: January 4, 2016 Received: January 5, 2016

Dear Ms. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 yours,

Tina Kiang -

for Erin I. Keith, M.S. 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)

K151274

Device Name

Dr's Finder

Indications for Use (Describe)

Dr's Finder is intended for detecting the apex of root canal.

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 (K151274)

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

Date: February 3, 2016

1. 510K Applicant / Submitter:

Good Doctors Co., Ltd. #208, Woolim Lions Valley B-dong, 283 Bupyeong-daero, Bupyeong-gu, Incheon 403-911, Republic of Korea Tel: +82-32-424-6325 Fax: +82-32-424-6326

2. Submission Contact Person

LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

Proprietary Name: Dr's Finder .
Common Name: Apex Locator .
. Classification: Unclassified (Pre-Amendment)
Product Code: LQY .

4. Predicate Device

. Primary Predicate Device: NAVI ROOT by S-Denti Co., Ltd. (K083901)
. Reference Predicate Devices: Multiple (Apex Locator), Model RCM-7 by J. MRITAMFG. CORP (K090925)

5. Description:

The device allows the relative position of a dental file and the apex to be determined electrically. Using a standard dental file inserted into the root canal as an electrode, the

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device emits very small electrical currents having frequencies of 400 Hz, and 10400 Hz. The current between the file and mouth is measured at each of these frequencies, and the readout of the relative proximity to the apex will appear on the meter.

8. Indications for Use

Dr's Finder is intended for detecting the apex of root canal.

9. Substantial Equivalence Discussion:

The Dr's Finder is substantially equivalent to the VAVI ROOT (K083901) and Root ZX mini (K090925). The Dr's Finder and the predicate devices have the same intended use, the same principles of operation and similar technological characteristics. The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use or substantial equivalence. The measurement current of the subject device is different from the primary predicate device; however, the reference predicate device has the same measurement current as the subject device. There is also a difference in frequencies used for measurement, however, a side by side performance test was performed on the subject device and the primary predicate device (K090925), and the test results show that the subject device would perform as well as the predicate device.

The materials used in the subject device might be different from the predicate devices as well, however, biocompatibility tests were performed and the results support that the subject device is biocompatible.

	Subject Device	PrimaryPredicate Device	ReferencePredicate Device
510(K) Number	-	K083901	K090925
Device Name	Dr's Finder(AL-DF10)	NAVI ROOT	MULTIPLE (APEXLOCATOR),MODEL RCM-7
Manufacturer	Good Doctors Co.,Ltd.	S-Denti Co., Ltd.	J. MRITAMFG. CORP
Product Code	LQY	LQY	LQY
Design	Image: Dr's Finder	Image: NAVI ROOT	Image: RCM-7
Intended Use	Dr's Finder isintended fordetecting the apex ofroot canal.	The NAVI ROOT isintended for measuringthe length of the rootcanal for the purpose of	RCM-7 is a dentaldevice, Apex Locator.It can be used to detectthe apex of root canal.

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		performing root canals.
Method ofcalculatinglocation of root	Comparison ofimpedancemulti frequencies	Comparison ofimpedance at multifrequencies	Comparison ofimpedance at multifrequencies
MeasurementCurrent	30 uA, maximum	5 uA±10%	30 uA, maximum
MeasurementPower	Lithium PolymerDC 4.2V(rechargeable)	DC 4.5V(AA 1.5V x 3ea)Hz	DC 4.5VLR03 (AAA size X3ea)batteries
Powerconsumption	0.29 W	150mW	0.2 W
Frequenciesusedfor comparison	400 Hz - 10,400Hz	500 Hz - 5,000 Hz	-
Display	OLED	LCD	LCD
Accessory	File hook, Lip hook,Probe cord	File hook, Lip hook,Probe cord	File hook, Lip hook,Probe cord
Accuracy	±0.2mm	±0.25mm	-
Dimensions(W x L x H)	55 x 85 x 21mm	153 x 138 x 44mm	60 x 103 x57mm
Weight	56g	425g	110g
Calibration	Not required	Not required	Not required

10. Performance Tests (Non-clinical)

. The comparison testing on Dr's Finder and the predicate device (RCM-7, K090925) was performed to compare the measurement performance of locating apex root using extracted tooth. Based on the test results, we conclude that the Dr's Finder is substantially equivalent to the predicate device.
. The EMC and electrical safety testing was conducted on the Dr's Finder in accordance with the following standards.
- EN 60601-1:2006. + A11:2011
- EN 60601-1-2:2007
- EN 61000-3-2:2006/A2:2009
- EN 61000-3-3:2013
- EN 55011:2009/A1:2010 GROUP 1, CLASS B i
. Biocompatibility testing performed on the File hook and the Lip hook in accordance with the following standards.
- ISO10993-5: 2009 Cytotoxicity Test
- ISO10993-10 : 2010 Intracutaneous (Intradermal) Reactivity Test
- ISO10993-10 : 2010 Sensitization (Maximization Test for delayed hypersensitivity)
To verify the sterility assurance level (105) for steam sterilization procedure of the file ● hook and the lip hook, the biological indicator (BI) overkill method was used in

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accordance to ISO 17665-1 and ISO 17665-2. In addition, dry time under full cycle was validated.

Software Validation Test .
The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences.

11. Conclusions:

Based on the information provided in this premarket notification, Good Doctors Co., Ltd. concludes that the Dr's Finder is substantially equivalent to the predicate device as described herein in.

Regulation Number and Section

N/A