The ECD is a portable instrument that provides an electrical current source, a meter with a digital read-out between 00 and 100, and indicator and reference electrodes to aid in the detection and monitoring of non-cavitated and cavitated caries lesions in teeth.

The ECD indicator electrode is comprised of a replaceable, single-use, stainless steel probe tip. This component is sized and dimensionally configured to achieve close contact with the tooth being examined. The tip ensures electrical contact with dentinal fluid at sites that are not readily accessible or evaluated using traditional means. The ECD indicator electrode is paired with a reference electrode to complete the necessary electrical circuit. The reference electrode is a stainless steel lip hook that rests on the patient's lower lip.

The device is powered by a 9 volt alkaline battery, regulated down to 5 volts. The unit has a 2 ½ digit LCD display, two timer circuits, and a beeper. The first timing circuit is triggered upon circuit completion. The beeper sounds for 3 seconds, the probe is then removed, and the second timer holds the display for 5 seconds. Then the display returns to zero, ready for the next measurement.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Electronic Caries Detector, based on the provided text:

Electronic Caries Detector Study Information

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Sensitivity	92% (compared to biopsy)
Specificity	100% (compared to biopsy)

Note: The document does not explicitly state "acceptance criteria" but rather presents performance metrics from a comparative study to establish substantial equivalence.

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

The document states that the testing included:

In vitro performance testing on extracted teeth
In vivo performance testing on teeth before and after extraction

However, it does not specify the sample size for either of these test sets, nor does it explicitly state the country of origin or whether the data was retrospective or prospective. The term "in vivo" implies prospective collections from human subjects, and "in vitro on extracted teeth" would be a lab-based study with human teeth.

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

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human reader improvement with or without AI assistance. The device description suggests it's a direct measurement tool, not an AI-assisted diagnostic.

6. Standalone Performance Study (Algorithm Only)

The provided text describes performance testing of the device itself, stating "In vitro performance testing on extracted teeth" and "In vivo performance testing on teeth before and after extraction." The reported sensitivity and specificity values are for the device's performance when compared to biopsy. This indicates a standalone performance study of the device's measurement capabilities.

7. Type of Ground Truth Used

The ground truth used for the reported performance metrics (sensitivity and specificity) was biopsy. The document states, "Performance: When compared to biopsy: 92% sensitivity, 100% specificity." It further notes, "Ortek believes that biopsy is considered the current gold standard and the performance scores are more significant compared to visual-tactile readings."

8. Sample Size for the Training Set

The document does not provide information on a separate training set or its sample size. The testing described appears to be for validation/performance evaluation rather than machine learning model training.

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

Since no separate training set is mentioned for a machine learning model, there is no information on how ground truth for a training set was established. The ground truth for the performance evaluation was established via biopsy.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ortek Therapeutics, Inc. % Allison Komivama Principal Consultant AcKnowledge Regulatory Strategies 2834 Hawthorn St. San Diego, California 92104

September 11, 2017

Re: K170822

Trade/Device Name: Electronic Caries Detector Regulation Number: 21 CFR 872.1745 Regulation Name: Caries Detection Device Regulatory Class: Class II Product Code: NBL, LFC Dated: August 10, 2017 Received: August 11, 2017

Dear Dr. Allison Komiyama:

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 (DICE) 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 (DICE) 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,

Marv S. Runner -S

for Lori Wiggins 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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Indications for Use

510(k) Number (if known) K170822

Device Name Electronic Caries Detector

Indications for Use (Describe)

The Electronic Caries Detector is for use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

Type of Use (Select one or both, as applicable)

ال Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image shows the logo for Ortek Therapeutics, Inc. The word "Ortek" is written in a stylized, blue font. Below the word "Ortek" is the phrase "Therapeutics, Inc." in a smaller, less stylized font. The logo is simple and professional.

510(k) Summary

510(k) Summary K170822

DATE PREPARED

September 5, 2017

MANUFACTURER AND 510(k) OWNER

Ortek Therapeutics, Inc. 4 Expressway Plaza, Roslyn Heights, NY 11577, USA Telephone: mgoldberg.ortek@gmail.com Email: Official Contact: Mitch Goldberg, President

REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies Telephone: +1 (619) 208-7888 akomiyama@acknowledge-rs.com Email:

TRADE/PROPRIETARY NAME OF SUBJECT DEVICE

Electronic Caries Detector

COMMON NAME

Laser Fluorescence Caries Detection Device

DEVICE CLASSIFICATION

Laser fluorescence caries detection device

PRODUCT CODE NBL, LFC

REGULATION NUMBER 21 CFR 872.1745

PREMARKET REVIEW

ODE/DAGRID/DEDB Dental Panel

INDICATIONS FOR USE

The Electronic Caries Detector is for use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

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Image /page/4/Picture/0 description: The image shows the logo for Ortek Therapeutics, Inc. The word "Ortek" is written in a stylized, blue font. Below the word "Ortek" is the text "Therapeutics, Inc." also in blue. The logo is simple and professional.

510(k) Summary

DEVICE DESCRIPTION

PREDICATE DEVICE IDENTIFICATION

The Electronic Caries Detector is substantially equivalent to the following predicates:

510(k)Number	Predicate Device Name / Manufacturer	PrimaryPredicate
K090598	CarieScan Pro - Cariescan LLC	✓
K982105	Oral Potential Meter - Pertec of Wisconsin, Inc.

SUMMARY OF NON-CLINICAL AND CLINICAL TESTING

No FDA performance standards have been established for Electronic Caries Detector. The following tests were performed to demonstrate substantial equivalence, based on current industry standards:

. Biocompatibility (per ISO 10993)
. In vitro performance testing on extracted teeth
In vivo performance testing on teeth before and after extraction

The results of these tests indicate that the Electronic Caries Detector is substantially equivalent to the predicate devices.

EQUIVALENCE TO PREDICATE DEVICES

Ortek believes that the Electronic Caries Detector is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has similar design, technological characteristics, and uses similar or identical materials as the devices cleared in K090598 and K982105. The subject device has identical indications for use as the device cleared in K090598 and identical intended use as the devices

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Image /page/5/Picture/0 description: The image shows the logo for Ortek Therapeutics, Inc. The word "Ortek" is written in a stylized, blue font. Below "Ortek" is the text "Therapeutics, Inc." in a smaller, simpler font. The logo is clean and professional.

510(k) Summary

cleared in K090598 and K982105. The ECD uses electrical conductance similar to the device cleared in K982105. The power source of the subject device differs compared to both predicates, however, it uses a lower voltage battery (9V) than the primary predicate (110V). Performance testing of the subject device is similar to the performance of the primary predicate, however, the ECD used a comparison to biopsy whereas the primary predicate compared to visual-tactile scores of the evaluated teeth. Ortek believes that biopsy is considered the current gold standard and the performance scores are more significant compared to visual-tactile readings.

CONCLUSION

The Electronic Caries Detector is considered substantially equivalent to the predicate devices based on the testing performed, the identical indications for use, and similar technological characteristics. Based on the testing performed, including biocompatibility, performance and clinical testing, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices.

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SubstantialEquivalence Summary	Subject Device	Primary Predicate	Reference Predicate
	Ortek Therapeutics, Inc.Electronic Caries DeviceK170822	CarieScan LtdCarieScan PROK090598	Pertec of Wisconsin, Inc.Oral Potential Meter (OPM)K982105
Indications for Use	The Electronic Caries Detectoris for use by dentalprofessionals as an aid in thediagnosis and monitoring ofdental caries.	For use by dentalprofessionals as an aid inthe diagnosis andmonitoring of dentalcaries.	The Oral Potential Meter aids the dental professional in detecting potential caries. Measurementsabove 10 millivolts, 1 microamp and 0.01 microwatts x seconds indicates a need for the dentalprofessional to look at potentially carious leasions by also using other means, such as directexploration, radiographs, etc. The OPM aids in determining potentially active caries and can notdetect mineralized caries that have no potenial energy. Remineralized teeth are no longerconsidered carious. The OPM is a device that measures and displays voltage and conducts throughcaries related to metallic restorations in the oral cavity. The dentist may be able to, on visualexam, detect caries at the margins or with x-ray under a restoration with these readings. It alsoprovides a power measurement (energy or joules) integrated over a measured period of time anddisplays it. The meter has two probes that are used to make the measurements. One is a referenceprobe, Red, with push-button switch to turn on the meter and initiate the measurements. Theother is used as the primary input, Black to the meter's electronics
Device Info
ProCodes / Reg #	NBL / 21 CFR 872.1745	NBL / 21 CFR 872.1745	LFC / 21 CFR 872.1740
Class	II	II	II
Intended use	Aid in caries detection	Aid in caries detection	Aid in caries detection
Where used	Dental office	Dental office	Dental office
Energy used and/ordelivered	Electrical conductance	Electrical impedance	Electrical conductance
Technological Characteristics
Power source	9 V, alkaline battery	110 V, Lithium polymerrechargeable battery	Alternating current (AC)
Measurement method	Measurement ofconductance	Comparison ofimpedance at multiplefrequencies	Measurement of conductance, voltage, and time
Performance	When compared to biopsy:92% sensitivity100% specificity	When compared tovisual-tactile:92.5% sensitivity92.5% specificity	Unknown
Maximum appliedcurrent	< 10 μΑ	< 10 μΑ	10 μΑ
Indicator electrode	Probe tip (stainless steel)	Probe tip sensor	Probe tip (stainless steel)
Provided sterile?	No	Yes	No
Sterilization method	Steam	Steam	Steam
Single use?	Yes	Yes	No
Reference electrode	Stainless steel lip hook(reusable)	Stainless steel lip hook(reusable)	Stainless steel
Test range	0-100	0-100	Unknown

Regulation Number and Section

§ 872.1745 Laser fluorescence caries detection device.

(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.