RAYPEX® 6 is a dental apex locator intended for precise localization of root canal apex. The measurements in RAYPEX® 6 are performed utilizing AC signals at two frequencies - 500 Hz and 8 kHz. The frequencies are alternated and not mixed, eliminating the need for signal mixing and frequency discrimination electronic circuits. The patented signal measuring method utilized in RAYPEX® 6 is based on measurements of RMS (Root Mean Square) level of the signal. Advanced user interface implemented in RAYPEX® 6 is based on high resolution touch TFT (Thin Film Transistor) color graphic display with touch panel. RAYPEX® 6 provides clear real time presentation of endodontic file movement inside the canal. RAYPEX® 6 shows the movement of the file inside the canal from the beginning of the measurements to the end, providing uninterrupted feedback to the dentist. File tracking algorithm enables full-scale display of the file movement during the treatment while Apical Zoom feature enables high-resolution indication of the file advance in pre-apical and apical zones. Large, clearly recognizable graphical readings in Apical Zoom are designed to enable precise control over the file advance matching the individual technique of the dentist. Visual information is accompanied by optional audio signals. The bars shown in the Apical Zoom do not represent actual distance from the apex in mm: they serve as a convenient reference to judge the file tip position in relation to the apex. Operation of RAYPEX® 6 is fully automatic. no manual calibrations or adjustments are required. The measured signal is analyzed and automatic adjustments are made if required. The device may operate within different conditions in the root canal: dry or wet. Built-in Demo mode of RAYPEX® 6 enables easy simulation of all stages of the treatment and is designed to simplify familiarization of the user with the device. Optional verification of proper operation of RAYPEX® 6 is possible through built-in Check mode which enables easy automatic check-up of both the device and its accessories. For practitioner's convenience the following user interface features may be set through RAYPEX® 6 device setup menu: display background color, preferred sound type and display brightness.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided text for the RAYPEX® 6 apex locator:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria in terms of accuracy metrics (e.g., percentage deviation from true apex within a specific range). Instead, the acceptance criterion for RAYPEX® 6 is based on demonstrating substantial equivalence to its predicate device, the BINGO PRO apex locator (K111474). This means the performance of RAYPEX® 6 must be "equivalent to" or "clinically acceptable" compared to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance (RAYPEX® 6)
Clinically acceptable measurements	"The results obtained with RAYPEX® 6 were compared to the results of the FDA cleared device - BINGO PRO apex locator. The conclusions of the test were that the measurements of RAYPEX® 6 apex locator are clinically acceptable."
Equivalence to the predicate device (BINGO PRO)	"The conclusions of the test were that the measurements of RAYPEX® 6 apex locator are clinically acceptable since they are equivalent to the results of BINGO PRO device."
Clinically acceptable measurements in presence of irrigation liquids	"RAYPEX® 6 measurements in presence of different, irrigation liquids are clinically acceptable."
Same intended use as predicate	"RAYPEX® 6 has the same intended use... as its predicate device - BINGO PRO (K111474)."
Same fundamental scientific technology as predicate	"RAYPEX® 6 has the same... fundamental scientific technology as its predicate device - BINGO PRO (K111474)."

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

Sample Size: The document does not specify the exact number of "extracted teeth" used for the ex-vivo test. It only states that the test was performed "on extracted teeth."
Data Provenance: The study was conducted "ex-vivo" (meaning outside a living organism, likely in a laboratory setting using extracted human or animal teeth). The country of origin for the data is not specified. It is a retrospective or prospective study from the perspective of how the test set was collected. Given that it's an ex-vivo test on extracted teeth, it would be considered prospective in the sense that the test was specifically designed and executed for this regulatory submission.

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

The document does not provide details on the number of experts or their qualifications used to establish the ground truth for the extracted teeth. The "ground truth" for an apex locator study typically involves physically measuring the true apex after the teeth have been prepared or sectioned.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (such as 2+1, 3+1, or none) for the test set.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described or performed. This study focuses on the standalone performance of the device compared to a predicate device, not on how human readers improve with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The "ex-vivo test was performed on extracted teeth" directly evaluating the RAYPEX® 6 apex locator's measurements and comparing them to those of the BINGO PRO apex locator. This assesses the device's ability to locate the apex on its own, without direct real-time human intervention influencing its measurement output.

7. Type of Ground Truth Used

The type of ground truth used is implied to be a physical measurement of the true apex on extracted teeth. While not explicitly stated, ex-vivo apex locator studies typically rely on histological or direct microscopic measurement of the true anatomical apex after the tooth has been prepared or sectioned.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. Apex locators like RAYPEX® 6 are typically engineered based on physical principles (impedance measurement at different frequencies) and do not usually involve machine learning models that require a "training set" in the conventional sense (i.e., for supervised learning). The "microprocessor controlled device" refers to its operational logic, not necessarily an AI algorithm trained on data.

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

Not applicable, as no training set (in the context of machine learning) is described for this device.

Summary

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1131907

JAN 3 1 2014

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SECTION 5. 510(k) SUMMARY for RAYPEX® 6

5.1 Submitter Information:
DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405 USA

Contact Person: Helen Lewis Telephone Number: 717-487-1332 Fax Number: 717-849-4343

Date Prepared: January 27, 2014

5.2 Candidate Device Details:
- Trade name/Proprietary Name: RAYPEX® 6 .
- Common Name: .
- Classification Name: .
- Product Code: .
- Review Panel: .
- Device Class: .

Apex Locator Locator, Root Apex LOY - Locator, ROOT APEX Dental Unclassified (Pre-Amendment)

5.3 Predicate Device Identification:

Device to which substantial equivalence is claimed is BINGO PRO apex locator of Forum Engineering Technologies (96) Ltd. (Israel), 510(k) number K111474.

5.4 Device Description:

RAYPEX® 6 is a dental apex locator intended for precise localization of root canal apex.

The measurements in RAYPEX® 6 are performed utilizing AC signals at two frequencies - 500 Hz and 8 kHz. The frequencies are alternated and not mixed, eliminating the need for signal mixing and frequency discrimination electronic circuits. The patented signal measuring method utilized in RAYPEX® 6 is based on measurements of RMS (Root Mean Square) level of the signal.

Advanced user interface implemented in RAYPEX® 6 is based on high resolution touch TFT (Thin Film Transistor) color graphic display with touch panel. RAYPEX® 6 provides clear real time presentation of endodontic file movement inside the canal.

DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street Suite 60W York, PA 17401 (800) 877-0020 Fax (717) 849-4343 www.dentsply.com

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RAYPEX® 6 shows the movement of the file inside the canal from the beginning of the measurements to the end, providing uninterrupted feedback to the dentist. File tracking algorithm enables full-scale display of the file movement during the treatment while Apical Zoom feature enables high-resolution indication of the file advance in pre-apical and apical zones. Large, clearly recognizable graphical readings in Apical Zoom are designed to enable precise control over the file advance matching the individual technique of the dentist. Visual information is accompanied by optional audio signals. The bars shown in the Apical Zoom do not represent actual distance from the apex in mm: they serve as a convenient reference to judge the file tip position in relation to the apex.

Operation of RAYPEX® 6 is fully automatic. no manual calibrations or adjustments are required. The measured signal is analyzed and automatic adjustments are made if required. The device may operate within different conditions in the root canal: dry or wet.

Built-in Demo mode of RAYPEX® 6 enables easy simulation of all stages of the treatment and is designed to simplify familiarization of the user with the device.

Optional verification of proper operation of RAYPEX® 6 is possible through built-in Check mode which enables easy automatic check-up of both the device and its accessories.

For practitioner's convenience the following user interface features may be set through RAYPEX® 6 device setup menu: display background color, preferred sound type and display brightness.

5.5 Indications for Use:
RAYPEX® 6 is a microprocessor controlled device used for locating the apex.

Device Characteristic	Predicate DeviceBINGO PRO	Proposed DeviceRAYPEX® 6
510(k)	K111474	Pending
Device Definition	Electronic apex locator	Electronic apex locator
Device Category	Active, invasive	Active, invasive
Indications for Use	BINGO PRO is anelectronic device used forprecise apex location andworking lengthdetermination during rootcanal treatment. The deviceenables to obtains correctresults in canals withdifferent conditions-dry orwet.	RAYPEX® 6 is amicroprocessor controlleddevice used for locating theapex.
Weight	300g	350g
Where to be used	This product must only beused in hospitalenvironments, clinics ordental offices by qualifieddental personnel.	This product must only beused in hospitalenvironments, clinics ordental offices by qualifieddental personnel.

5.6 Substantial Equivalence Comparison

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Device Characteristic	Predicate DeviceBINGO PRO(K111474)	Proposed DeviceRAYPEX® 6
Display	3.5" color TFT(portrait orientation)	3.5" color TFT(landscape orientation)
Training mode	DEMO mode is used todemonstrate deviceoperation and to shortenlearning curve of the user.	DEMO mode is used todemonstrate deviceoperation and to shortenlearning curve of the user.
Check mode	Not available.	"Check mode" built-infeature utilizing dedicatedtester allows checkingoperation of both the deviceand the accessories.
Power Source	NiMH rechargeablebatteries (2.4V)	NiMH rechargeablebatteries (2.4V)
Extrenal charge	Input: 120V/50-60HzOutput: 6V DV @ 500mA	Input: AC 100-240V:50/60HzOutput: 5VDC @ 1,000mA
Automatic Turn-Offfunction	The device turns offautomatically after 5 min.of idle state.	The device turns offautomatically after 5 min.of idle state.
Sound indication	Piezzo transducer withsound level control (high,medium, low, mute)	Speaker which enables:-sound level adjustmentfrom mute to high soundlevel-tone selection
Additional features	Not available	For practioner'sconvenience user interfacesetup is available, includingselection of:• Display backgroundcolor• Sound type• Display brightness

5.7 Non-Clinical/Clinical Performance Data

To evaluate the performance of RAYPEX® 6 apex locator, ex-vivo test was performed on extracted teeth. The results obtained with RAYPEX® 6 were compared to the results of the FDA cleared device - BINGO PRO apex locator.

The conclusions of the test were that the measurements of RAYPEX® 6 apex locator are clinically acceptable since they are equivalent to the results of BINGO PRO device and that RAYPEX® 6 measurements in presence of different, irrigation liquids are clinically acceptable.

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5.8 Conclusion as to Substantial Equivalence
- RAYPEX® 6 has the same intended use and fundamental scientific . technology as its predicate device - BINGO PRO (K111474).
- The similarities in the design, indications for use, fundamental product . technology, and the results of comparative performance testing support the substantial equivalence of the RA YPEX® 6 to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling a human figure embracing a bird, which is a common emblem associated with the department.

Public Health Service

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

January 31, 2014

DENTSPLY International Ms. Helen Lewis Director, Corporate Regulatory Affairs Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

Re: K131907

Trade/Device Name: RAYPEX® 6 Regulation Number: Unclassified Regulation Name: Locator, Root Apex Regulatory Class: Unclassified Product Code: LQY Dated: December 20, 2013 Received: December 24, 2013

Dear Ms. Lewis:

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 - Ms. Lewis

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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.

Image /page/5/Picture/7 description: The image shows the name Kwame Ulmer in bold black font. Below the name is the acronym FDA in a stylized font. The letters are large and blocky, and they appear to be made up of smaller squares or rectangles.

for

Erin I. Keith, M.S. Acting 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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SECTION 4. INDICATIONS FOR USE STATEMENT

510(k) Nümber (if known):: K 131907

Device Name; RAYPEX® 6

Indications for Uses

RAYPEX® 6 is a microprocessor controlled device used for lacating the apex.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BECOW THIS LINE-GONFINUE ON ANQTHER PAGE IF NERDED)

Concurrence of CDRH. Office of Device Busination (ODE)

Mary S. Runner -5 Saces Room Dog not 2014.01.28 13:53:26 -05:00.

000008 DENISTA International

Regulation Number and Section

N/A