The ApexNRG Rider is indicated for the measurement of the length of the root canals and related dental procedures, for use by a trained professional in general dentistry.

Device Description

The ApexNRG Rider is a dental apex locator which has the ability to measure the depth of the root canal by electronic means.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ApexNRG Rider device:

The provided document, a 510(k) Summary, primarily focuses on demonstrating substantial equivalence to a predicate device (MedicNRG DAL Apex Locator, K080113) rather than detailing specific acceptance criteria and a standalone study for the ApexNRG Rider's clinical performance. The testing mentioned is non-clinical.

Summary of Device Performance and Acceptance Criteria (Based on Substantial Equivalence to Predicate):

The document doesn't explicitly state numerical acceptance criteria for clinical performance that the ApexNRG Rider itself must meet in a standalone study. Instead, its performance is implicitly accepted as meeting the same standards as its predicate device because it is deemed "substantially equivalent" in technology and intended use.

The table below reflects the characteristics stated to be "same" as the predicate, implying these common characteristics are the de facto "acceptance criteria" through equivalence.

Acceptance Criteria (Implied from Predicate Equivalence)	Reported Device Performance (ApexNRG Rider)
Intended Use:	To measure 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
Electric Current:	Less than 10 μA
Method of calculating location of root canal apex:	Comparison of a multi-frequency response signal using DSP technology with a different algorithm reducing the delay between calculation and display of measurement. The signals are generated as a response to multi-frequency signals having a 6.5 and 1.3 kHz repetition rate. The frequencies used for comparison 6.5 kHz - 1.3 kHz Square Wave with 3 cycles used for measurement.
Frequencies used for comparison:	6.5 kHz - 1.3 kHz Square Wave
Number of cycles used for measurement:	3
Display:	6 LED- Distance provided every 0.25 mm from 0.5 mm to the apex. (Note: Predicate has 8 LED, but "Distance provided every 0.25 mm from 0.5 mm to the apex" is deemed "Same")*
Adjustment before measurement:	Not required
Measuring Voltage:	Up to 15 mV

Interpretation Note: While the predicate has 8 LEDs and the modified device has 6, the document states "Same" for the 'Display' characteristic, implying that the critical function of providing distance every 0.25mm from 0.5mm to the apex is preserved and equivalent, despite the different number of LEDs.

Detailed Study Information:

Based on the provided text, a formal clinical study with detailed results for the ApexNRG Rider to meet specific acceptance criteria is not described. The document explicitly states:

"The determination of substantial equivalence is based on an assessment of non-clinical performance data. This testing consisted EMC and Electrical Testing as well as Software Validation. The results of this testing supported a determination of substantial equivalence."

Therefore, many of the requested items cannot be answered as directly applicable to a clinical performance study of the ApexNRG Rider itself.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated for clinical performance. The "testing" mentioned is non-clinical (EMC, Electrical, Software Validation).
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):
- Not applicable/Not stated. No clinical test set with a ground truth established by experts is described for the ApexNRG Rider.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not stated. No clinical test set requiring adjudication is described.
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:
- No such study was done/described. The device is an apex locator, which is a measurement device, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A "standalone" performance was not described in the clinical sense. The entire submission hinges on demonstrating substantial equivalence to a predicate device, focusing on non-clinical performance data and technological similarities. There is no specific clinical "algorithm only" performance study detailed for this device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not stated for clinical performance. The "ground truth" for the non-clinical tests would be defined by engineering standards and specifications (e.g., electrical safety standards for EMC and Electrical Testing, software requirements for Software Validation).
The sample size for the training set:
- Not applicable/Not stated. The document describes a specific dental apex locator for measurement, not a machine learning or AI system that requires a "training set" in the conventional sense.
How the ground truth for the training set was established:
- Not applicable/Not stated. As no "training set" for an AI/ML algorithm is mentioned, this information is not provided.

Summary

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OCT 0 8 2010

Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be "K101177". The characters are written in black ink on a white background. The handwriting is somewhat messy, but the characters are still legible.

14,

510(k) Summary of Safety & Effectiveness

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

Submitter George J. Hattub 1. (a) Address: MedicSense, USA 291 Hillside Avenue Somerset, MA 02726 www.medicsense.com 1. (b) Manufacturer MedicNRG, Ltd. PO Box 338, MP Jordan Valley Address: Kibbutz Afikim, Israel 15148 Mfg. Phone: 972-4-675-4217 Contact Person: Michal Zach, QA Manager June 12, 2010 Date: 2. Device & Classification Locator, Root, Apex, Class 2, Product Code LQY, unclassified Name: ApexNRG Rider(Apex Locator) MedicNRG ApexDAL Apex Locator (K080113) Predicate Device: 3. Description: The ApexNRG Rider is a dental apex locator which has the ability to 4. measure the depth of the root canal by electronic means. The ApexNRG Rider is intended for the measurement of the length of the ક. Intended Use: root canal for purposes of performing root canals and related dental ﺮﮮ ۔ ۔ procedures, for use by a trained professional in general dentistry. With respect to technology and intended use, the Modified MedicNRG-Comparison of 6. Rider (Apex Locator) is substantially equivalent to its predicate device which Technological is the MedicNRG DAL Apex Locator. The primary difference is that the Characteristics: modified device can be used in conjunction with a dental handpiece or as a separate, external unit. Like its predicate device (K080113) it utilizes a multi-frequency response signal using DSP technology with a fast algorithm reducing the delay between calculation and display of measurement. The signals are generated as a response to multi-frequency signals having a 6.5 and 1.3 kHz repetition rate. The following table delineates the differences between the predicate device and the ApexNRG Rider

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DeviceCharacteristic	Modified DeviceApexNRG Rider	PredicateDeviceApex DALElectronicApex Locator	Comment
Intended Use	To measure thelength of the rootcanal for thepurpose ofperforming rootcanals and relateddental proceduresfor use by a trainedprofessional ingeneral dentistry	To measurethe length ofthe root canalfor thepurpose ofperformingroot canalsand relateddentalproceduresfor use by atrainedprofessionalin generaldentistry	same
Power Source	Single CR2450 V	AA 1.5 V	different
ElectricCurrent	Less than 10 μA	Less than 10 μA	same
Method ofcalculatinglocation of rootcanal apex		Comparison of amulti-frequencyresponse signalusing DSPtechnology with adifferent algorithmreducing the delaybetween calculationand display ofmeasurement. Thesignals aregenerated as aresponse to multi-frequency signalshaving a 6.5 and1.3 kHz repetitionrate. Thefrequencies usedfor comparison 6.5kHz - 1.3 kHzSquare Wave with3 cycles used formeasurement.		Comparisonof a multi-frequencyresponsesignal usingDSPtechnologywith adifferentalgorithmreducing thedelaybetweencalculationand display ofmeasurement.The signalsare generatedas a responseto multi-frequencysignals havinga 6.5 and 1.3kHz repetitionrate. Thefrequenciesused forcomparison6.5 kHz - 1.3kHz SquareWave with 3cycles usedformeasurement.	same

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Frequenciesused forcomparison	6.5 kHz - 1.3 kHzSquare Wave	6.5 kHz - 1.3 kHz SquareWave	same
Number ofcycles used formeasurement	3	3	same
Display	6 LED- Distanceprovided every 0.25mm from 0.5 mmto the apex.	8 LED-Distanceprovidedevery 0.25mm from 0.5mm to theapex.	Same
Adjustmentbeforemeasurement	Not required	Not required	Same
MeasuringVoltage	Up to 15 mV	Up to 15 mV	Same
Weight	26 grams	50 grams	Same
Dimensions	L:67 x W: 34 x H:19 mm	L: 87 x W: 60x H: 18 mm	Same

Based upon the testing results, MedicNRG believes this difference does not raise additional safety of efficacy concerns.

7. Testing

The determination of substantial equivalence is based on an assessment of non-clinical performance data. This testing consisted EMC and Electrical Testing as well as Software Validation. The results of this testing supported a determination of substantial equivalence.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, rendered in a simple, bold design.

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

Medicnrg, Limited C/O Mr. George Hattub Medicsense, USA 291 Hillside Avenue Somerset, Massachusetts 02726

OCT 0 8 2010

Re: K101177

Trade/Device Name: ApexNRG Rider (Apex Locator) Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LQY . Dated: August 24, 2010 Received: August 30, 2010

Dear Mr. Hattub:

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. Hattub

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

h 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):

Device Name: ApexNRG Rider (Apex Locator)

Indications For Use: The ApexNRG Rider is indicated for the measurement of the length of the root canals and related dental procedures, for use by a trained professional in general dentistry.

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)

Susan Runne

(Division Sign-Off) Division of Anesthesiology, General പ്രവ്യൂട്ടുപ്പ്മി of 1 infection Control, Dental Devices

510(k) Number: K01177

Regulation Number and Section

N/A