Measurement of the length of the root canal for the purpose of performing root canals and related dental procedures, for use by a trained professional in general dentistry.

Device Description

The Apex NRG is used to measure the distance to the apex during root canal procedures. A low frequency low volt AC signal is applied between the lip electrode and the endodontic file, which is inserted into the root canal. The impedance of the tissues between the electrodes change as the file advances toward the root apex and the measured signals are used to monitor the progress of the file in the tooth.

The Apex NRG operates on the measurement of a weak electrical current flowing between two electrodes. One electrode is a metal hook that rests on the patient's lower lip and the other is the endodontic file that is attached to the file clasp and inserted into the canal. Multi frequencies are used to minimize errors that may be introduced by the entrance of conducting materials such as blood into the canal.

The ratio of the impedance values measured in the canal and lip are calculated to provide a measure of the probe tip relative to the apical foramen. The device consists of a main body incorporating the display, a lip hook, a file clasp and an apron clasp. The device is powered by one 200mAH CR2032 battery

AI/ML Overview

Here's an analysis of the provided text regarding the Apex NRG device, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state formal acceptance criteria with specific thresholds (e.g., "accuracy > 90%"). Instead, the clinical study's objective was to demonstrate substantial equivalence to predicate devices and agreement with radiographic working length. Therefore, the "acceptance criteria" can be inferred as showing comparable performance to the predicate devices and the radiographic method.

Acceptance Criteria (Inferred)	Reported Device Performance (Apex NRG)
Comparable performance to Root ZX apex locator	"The results obtained from the ROOT ZX and the Apex NRG were nearly identical."
Comparable performance to Apit 7™ apex locator (where tested)	"The results obtained from the Apit 7™ were in high agreement to both the ROOT ZX and the Apex NRG."
Similar results to radiographic working length determination	"The results obtained from the ROOT ZX and the Apex NRG were nearly identical and were similar to those obtained by radiography."

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

Sample Size: The study included 69 root canals from 30 teeth.
Data Provenance: The study was conducted at the Department of Endodontic, School of Dental Medicine Hebrew University, Jerusalem, Israel. The data is prospective, as patients were evaluated using the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: The document states that the radiographic working lengths, which served as a ground truth, "were determined by the investigators." It does not specify the exact number of investigators or experts.
Qualifications of Experts: The experts are referred to as "investigators" from the "Department of Endodontic, School of Dental Medicine Hebrew University, Jerusalem Israel." This implies they are qualified endodontists or dental professionals with expertise in determining root canal length via radiography. Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1, 3+1). It states that the radiographic working lengths "were determined by the investigators." This suggests that the investigators established the ground truth without a formal multi-reader adjudication process mentioned in the filing.

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

MRMC Study: This was not an MRMC comparative effectiveness study in the context of human readers improving with AI assistance. The Apex NRG is an electronic apex locator, not an AI software. The study compared the device's measurements to other electronic apex locators and to radiographic measurements.
Effect Size: Therefore, there is no reporting of an effect size of how much human readers improve with AI vs. without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, the clinical study essentially assessed the standalone performance of the Apex NRG device. The device provides an electronic reading, which was then compared to other electronic devices and a radiographic ground truth. Human intervention was in using the device and interpreting radiographs, but the device's core measurement ability was tested directly.

7. The Type of Ground Truth Used

The primary ground truth used for comparison was radiographic working length, which was "determined by the investigators." This is an expert consensus ground truth based on a diagnostic imaging method.

8. The Sample Size for the Training Set

The document does not mention any training set or details about how the device's algorithms (which likely involve impedance measurements and calculations) were developed or trained. This type of device, an electronic apex locator, likely relies on pre-programmed physics-based algorithms rather than machine learning models that require a 'training set' in the conventional sense.

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

As no training set is mentioned for the Apex NRG, which appears to be a hardware device with inherent electronic measurement principles, the concept of establishing ground truth for a training set in the AI/ML context is not applicable here. The device's design is based on established electro-physiological principles for apex localization.

Summary

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MAR 1 5 2004

K032743

MEDICALIA

510(k) Summary of Safety and Effectiveness

The Following 510(k) Summary of Safety and Effectiveness has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR § 807.92(a).

807.92(a)(1) - Submitter Details:

Submitter name:	MedicNRG Ltd.
Address:	Kibbutz Afikim, Israel 15148
Tel/Fax:	+972-4-6754278
Preparer of application:	MedicNRG Ltd.
Address:	P.O.Box 367, Ramat Ha'Sharon, Israel 47103
Phone number:	+972-3-923-3666
Fax number:	+972-3-923-1274
Official Correspondent:	Adi Ickowicz
Phone number:	+972-3-923-3666
Fax number:	+972-3-923-1274
Mobile:	+972-5-375-3829
e-mail:	adi@medicsense.com

July 25, 2003

807.92(a)(2) - Device Details:

Trade Name:	Apex NRG - Electronic Apex Locator
Common Name:	Apex Locator
Classification Regulation:	510(k) non exempt
Class:	Unclassified
Product Code:	LQY - LOCATOR, ROOT APEX

Date:

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MEDICNIA

807.92(a)(3) — Predicate Devices:

Medical DeviceName	Applicant Name	510(k)Number	Classification
JUSTWO TME-601Root Apex Locator	Toei Electric Co,POBox 7007Deerfield, IL 60015	K022020	unclassified
ROOT ZX	J. Morita USA, Inc.9 MasonIrvine, CA 92618	K921979	unclassified

Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table.

807.92(a)(4) - Device Description:

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MEDICALIA

807.92(a)(5) -- Device Intended Use:

Measurement of the length of the root canal for the purpose of performing root canals and related dental procedures, for use by a trained professional in general dentistry.

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MEDICAI:(ન

807.92(a)(6) – Substantial Equivalence Comparison Table:

	Candidate Device	Predicate Devices
DeviceCharacteristic	Apex NRG	ROOT ZX (K921979)	JUSTWO TME-601Root Apex Locator(K022020)
Intended Use	To measure thelength of the rootcanal for the purposeof performing rootcanals and relateddental procedures foruse by a trainedprofessional ingeneral dentistry.	Measurement of theroot canal for thepurpose ofperforming rootcanals and relateddental procedures.	To measure the lengthof the root canal for thepurpose of performingroot canals and relateddental procedures foruse by a trainedprofessional in generaldentistry
Power Source	One CR2032 battery200mAH	5 AA batteries	4 AAA batteries
Electric Current	Less than 40 µA	Less than 10 µA	Less than 10 µA
Method ofcalculatinglocation of rootcanal apex	Comparison ofimpedance at multifrequencies	Comparison ofimpedance at twofrequencies	Measurement ofcurrent at twofrequencies
Frequencies usedfor comparison	6.5 kHz - 1.3 kHz	400 Hz - 8000 Hz	500 Hz - 200 Hz
Number of cyclesused formeasurement	Multi frequency	2	2
Display	LED	Liquid crystal	Analog
Adjustment beforemeasurement	Unnecessary	Unnecessary	Unnecessary
Measuring Voltage	Up to 15 mV	80 mV	50 mV
Audio locationindicator	No	Yes	Yes
Weight	31 g	550 g	280 g
Use with standarddental file	Yes	Yes	Yes
Automatic On/Offswitch	Yes	No	Yes

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MEDICALIA

Clinical Testing:

A clinical study was performed at the Department of Endodontic, School of Dental Medicine Hebrew University; Jerusalem Israel comparing the Apex NRG with two commercially distributed apex locators; the Root ZX™ and the Apit 7™ to radiographic working length. Each patient was evaluated using the Apex NRG, the ROOT ZX and in some cases randomly using the Apit 7™, and the radiographic method. The study included 69 root canals from 30 teeth. The electronic readings were compared to those of the radiographs working length, which were determined by the investigators. The results obtained from the ROOT ZX and the Apex NRG were nearly identical and were similar to those obtained by radiography. The results obtained from the Apit 7™ were in high agreement to both the ROOT ZX and the Apex NRG.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2004

MedicNRG Limited C/O Mr. Adi Lckowicz Official Correspondents Medicsense P.O. Box 367 Ramat Ha' Sharon, ISRAEL 47103

Re: K032743

Trade/Device Name: Apex NRG- Electronic Apex Locator Regulation Number: Unclassified Regulation Name: Nonc Regulatory Class: None Product Code: LQY Dated: December 1, 2003 Reccived: January 12, 2004

Dear Mr. Ickowicz :

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 cither class II (Special Controls) or class III (PMA), it may be subject to such 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. Ickowicz

Please be advised that F.DA'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 your 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/cdrls/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

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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D. Statement of Indication for Use

510(k) Number (if known): K032743

Device Name: Apex NRG - Electronic Apex Locator

Indication For Use:

Measurement of the length of the root canal for the purpose of performing root canals and related dental procedures, for use by a trained professional in general dentistry.

(PLEASE DO NOT WRITE BELOW THE LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODF)

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use

(Optional Format 1-2-96)

Kace Mulhep for MSR

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

510(k) Number. K032743

Regulation Number and Section

N/A