The subject device is a lightweight, fully-automatic, battery operated device that allows a dentist or oral surgeon to locate a patient's anatomical root canal apex and obtain accurate root canal length measurements

AI/ML Overview

The provided document describes the i-ROOT Electronic Apex Locator, focusing on its substantial equivalence to a predicate device, the Navi ROOT (K083901). The information presented does not include a detailed study with acceptance criteria and reported device performance metrics in the way a clinical or standalone performance study would.

Instead, the document focuses on demonstrating substantial equivalence based on technological characteristics and intended use, aligning with the FDA 510(k) pathway. The "performance" section primarily refers to safety compliance with IEC standards and a general statement about equivalence.

Therefore, many of the requested elements for a detailed acceptance criteria study are not explicitly present in the provided text. However, an attempt to extract and infer information relevant to your request is made below, with clear indications where information is not available from the given document.

Acceptance Criteria and Device Performance for i-ROOT Electronic Apex Locator

The provided document describes the i-ROOT's performance in the context of demonstrating substantial equivalence to a predicate device (Navi ROOT, K083901) for its 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The main performance metric explicitly stated for both the i-ROOT and its predicate device is accuracy in measuring the root canal length.

Acceptance Criteria	Reported Device Performance (i-ROOT)
Accuracy	±0.25mm

Note: This "acceptance criteria" is derived from the predicate device's stated accuracy, which the i-ROOT is intended to match, thereby demonstrating substantial equivalence. The document implies that the i-ROOT meets this performance identical to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): Not explicitly stated in the provided document. The document describes a comparison between the i-ROOT and the predicate device at a technical specification level. It does not detail a specific test set of patients or measurements used to validate the ±0.25mm accuracy for the i-ROOT itself.
Data Provenance: Not explicitly stated. Given it's a 510(k) submission and the manufacturer is based in Seoul, Korea, the "testing" (likely internal verification) would presumably occur there, but no details are provided. It does not specify if data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not available in the provided text. The document does not describe a study involving expert readers or ground truth establishment in this manner.

4. Adjudication Method for the Test Set

This information is not available in the provided text. No multi-reader or adjudication process is described.

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

No MRMC comparative effectiveness study is mentioned. The document focuses on the technical specifications and safety compliance of the device itself, not on its impact on human reader performance.

6. Standalone (Algorithm Only) Performance Study

The i-ROOT device is a standalone device (an "algorithm only" or device-only performance in this context, without human-in-the-loop directly influencing its measurement output).
The reported performance is its accuracy of ±0.25mm. This implies that the device, when used as intended, provides measurements within this tolerance. However, the study proving this specific standalone performance for the i-ROOT (beyond simply stating it's identical to the predicate) is not detailed. The document only states, "The performance tests demonstrated that i-ROOT is as safe, as effective and performs in a substantially equivalent manner to the predicate device."

7. Type of Ground Truth Used

This information is not explicitly detailed for how the ±0.25mm accuracy was established or verified. Typically, for root canal length measurement ground truth might involve:
- Direct visual measurement: After tooth extraction, physically measuring the canal length.
- Radiographic measurement: Correlation with X-ray images.
- Surgical/Histopathological confirmation: In cases where direct access or removal allows.
- The document does not specify which method was used to validate the accuracy claim.

8. Sample Size for the Training Set

This information is not available within the provided text. The i-ROOT is an electrical impedance-based device, not a machine learning or AI-based system that would typically have a "training set" in the conventional sense. Its "training" would be its design and calibration processes.

9. How the Ground Truth for the Training Set Was Established

As the device is not a machine learning model, the concept of a "training set" and its associated ground truth establishment is not applicable in the context of this document.

Summary

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Kloused

ട്. 510(k) Summary

[as required by 807.92(c)]

NOV 1 8 2010

A. Applicant:

, 2 - 8

-Company name: S-Denti Co.,Ltd

-Address: 14F NO1407, Kolon Digital Tower Aston, 505-14, Gasan-dong, Geumcheon-gu, Seoul Korea -Tel:+82-2-2082-8828Fax:+82-2-2-2082-8829 web:www.s-denti.com

-Contact person: Peter Chung 412-687-3976

-Date: Dec 28th, 2009

B. Proprietary and Established Names:

Trade Name: i-ROOT Common Name:. Root Apex Locator Ragulation Name: Root Apex Locator Regulatory Classification: Unclassified, Dental, Product Code: LQY

C. Predicate device: Navi ROOT(K083901)

D. Device Description

E. Intended use

The i-ROOT is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures

F. Technological Characteristics:

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 500 Hz and 5 KHz. The current between the file and mouth is measured at each of these frequencies, and compared, with readout of the relative proximity to the apex appearing on a stabilized meter. The use of two frequencies minimizes errors introduced by blood or other conducting medicinal fluids in the root canal.

G. Performance (Safety and Effectiveness Information)

The i-ROOT has been manufactured and tested to meet the safety requirements of IEC. The i-ROOT complies with IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety and IEC 60601-1-2:2001, Medical electrical equipment - Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests.

I. Conclusion:

The performance tests demonstrated that i-ROOT is as safe, as effective and performs in a substantially equivalent manner to the predicate device

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11.1 Comparison Table ________________________________________________________________________________________________________________________________________________________

Product	i-ROOT	Navi ROOT
510K No		K083901
Manufacturer	S-Denti Co.,Ltd	S-Denti Co.,Ltd
Intended Use	Measurement of the length of theroot canal for the purpose ofperforming root canals and relateddental procedures	Identical
Method of calculating	Comparison of impedance at multifrequencies	Identical
Electric Current	Input Current : DC 40 mAPatient auxiliary current : AC 10 mA	Less than 10pA
Electrical Power	Lithium-ion Battery 8.2VDC(4.1VDCx2)	DC 4.5V(AA Battery 1.5Vx3EA)
Power consumption	0.33VA	180mW Max(150mW)
Measuring Voltage	80mV	Identical
Frequencies usedfor comparison	500 Hz, 5 kHz	Identical
Time of use	2000 Hr Continuous	Identical
Display	LCD	Identical
Accessory	Probe cord 1EA, Lip holder 5EA,File holder A 1EA,File holder B 2EA,AC adapter 1EA,User manual 1EA,USB Cable 1EA(optional),PC software CD(optional) 1EA	Probe cord 1EA,File holder 2EA,
Accuracy	±0.25mm	Identical
Storage condition- Temperature	-20 ~ 70℃	-10 ~ 60 ℃
- Humidity	0 ~ 95%	10 ~ 80RH%
Dimensions(LxWxH)	110mm(W) x 100mm(D) x 117mm(H)	153mm(W) x 138mm(D) x 44mm(H)
Weight	Approx. 372g ± 24g	420g

Conclusion

Based upon the intended use, and upon the similarity of product configuration and administration, it can be concluded the i-ROOTis substantially equivalent to the identified predicate device in terms of intended use, safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 an abstract caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

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

Mr. Tae Kye Nam S-Denti Company, Limited 505-14, Gasan-Dong, Geumcheon-Gu Seongnam-City, Seoul Republic of Korea 153-803

NOV 1 8 2010

Re: K100450

Trade/Device Name: i-ROOT Electronic Apex Locator Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: LQY Dated: August 18, 2010 Received: October 25, 2010

Dear Mr. Nam:

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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Page 2- Mr. Nam

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number (if known): K 100 450 ------------------------------------------------------------------------------------------------------------------------------------------

NOV 1 8 2010

Device Name: i-ROOT Electronic Apex Locator

Indications For Use:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . :

The i-ROOT is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1
Susan Punny

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K100460

Regulation Number and Section

N/A