The TIA Tip is a diagnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva.

Device Description

The TIA Tip is an optional interchangeable component tip assembly that works with the Dental CAD/CAM System Scanner. With the TIA Tip installed the system allows for the simultaneous side by side visualization of live transilluminated and color imaging of the patient's dental anatomy, as well as providing the user with the ability to capture and save transilluminated static images to a patient digital file. The system consists of:

Dental Scanner .
TIA Tip ●
Computer with Software ●

With one of the other provided interchangeable scanning tips installed, the system is also used to process dental restorations that are regulated under 21 CFR 872.3661, Optical Impression Systems for CAD/CAM of Dental Restorations.

The Scanner is a hand-held electronic device that consists of three parts: the scanner body, the TIA Tip and a custom USB data cable that connects the scanner to the computer. The scanner contains the electrical and opto-mechanical components.

The USB cable uses industry standard USB 3.0 type-A and type-C connectors, and the cable assembly is detachable making it easily replaceable.

The TIA tip must be connected to the scanner to work. It incorporates two "probes" containing Light Emitting Diodes (LEDs) that emit 727nm near infrared light.

In operation the probes conform to dental anatomy to direct light into the desired area of inspection. The light penetrates the tooth surface due to the translucent nature of dental anatomy. This allows a user to visualize the inner structure of the tooth and specifically to detect irreqularities like caries that show up as dark areas or spots on the transilluminated image. The scattering light of the illuminated anatomy is reflected by the tip mirror and directed toward the camera in the scanner which allows for a digital image to be captured.

The tooth is illuminated with light from both the scanner's laser projection system (RGB) and the TIA Tip LED's. Timing of the light is controlled through the electronics and is divided into separate frames. Collecting and presenting these images at many frames per second allows simultaneous "live" views of transilluminated image and full color view to the system operator. This allows the user to better visualize caries that cannot be detected with standard color imaging. For example, a proximal dental cavity becomes visible as a dark region in the transilluminated image.

The software will also allow for the capture of static images throughout the inspection process if the user wishes to document an area of interest and show the patient to discuss treatment options.

The software operates on a laptop or desktop pc. A network connection is required for interoperability.

When the TIA Tip is installed, it is automatically detected by the scanner and the operator is presented with both a transilluminated view and a live view simultaneously. The operator is provided with controls on the scanner to start/stop and toggle TIA illumination from Both/Right/Left LEDs to enhance TIA viewing. Additionally, on screen controls allow for TIA illumination intensity control for further TIA view optimization. Image capture of simultaneous TIA and live view images is provided which can be used for later reference. No digitization occurs during TIA viewing.

AI/ML Overview

The provided text describes the TIA Tip, Cariosity, Transillumination Accessory Tip, P/N 156930xx and its substantial equivalence to a predicate device. However, the document explicitly states that "Clinical testing is not required and has not been performed," and therefore it does not contain a study proving the device meets acceptance criteria.

Instead, the document focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text, noting where information is not available:

1. Table of acceptance criteria and the reported device performance

Since no clinical study was performed to establish acceptance criteria for detection performance, this table cannot be provided from the given text. The document refers to "Key performance attributes tested and compared include: a. LED illumination and output power, b. Image Quality" to demonstrate similar performance to the predicate device, not to meet specific acceptance criteria for caries detection.

2. Sample size used for the test set and the data provenance

Not applicable, as no clinical or comparative performance study using a test set was conducted for caries detection. The non-clinical tests relate to hardware performance and safety.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical study or test set requiring expert ground truth was conducted.

4. Adjudication method for the test set

Not applicable, as no clinical study or test set requiring adjudication was conducted.

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

No MRMC comparative effectiveness study was done. The device does not incorporate AI; it is a transillumination accessory for direct visualization.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as the device is a diagnostic aid for human viewing and does not involve a standalone algorithm for performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no ground truth for caries detection performance was established due to the absence of a clinical study for this purpose.

8. The sample size for the training set

Not applicable, as the device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as the device is not an AI/ML algorithm that requires a training set.

Summary of Non-Clinical Performance Testing (as described in the document):

The TIA Tip was evaluated through non-clinical performance testing to demonstrate substantial equivalence to the predicate device, the CamX Triton HD Proxi. The key aspects tested and compared were:

LED illumination and output power: The comparison table indicates that while the TIA Tip uses 727nm wavelength LEDs and the predicate uses 850nm, the output power (Max 3.74mW/cm² for TIA Tip at 3.845 mm vs. Max 2.00 mW/cm² for predicate at 7mm) was considered "almost the same" when measured side-by-side using the same equipment and test environment, accounting for measuring distance differences.
Image Quality: Specific metrics or quantitative results for image quality are not provided in this summary, but it states "image quality of potential caries detection products are similar for both Duerr Dental AG's CamX Triton HD Proxi and E4D's TIA Tip."

Additionally, the device complied with several safety and biocompatibility standards:

IEC 60601-1 Edition 3.1 - Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 – Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ISO 17665-1 (Sterilization validation – Moist Heat)
ISO 10993 series (Biocompatibility Testing), specifically ISO 10993-10 for Irritation and Delayed Hypersensitivity, and ISO 10993-5 for Cytotoxicity.

Conclusion stated in the document:
Based on similarities in indications for use and technological characteristics, together with results of non-clinical performance testing, it is concluded that the TIA Tip is substantially equivalent to the CamX Triton HD Proxi Head system. This substantial equivalence determination allows the device to be marketed without the need for a new clinical study demonstrating specific acceptance criteria for caries detection performance.

Summary

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April 29, 2022

D4D Technologies, LLC Eddie Anderson Regulatory Affairs Manager 2920 Telecom Parkway, Suite 100 Richardson, Texas 75082

Re: K213482

Trade/Device Name: TIA Tip, Cariosity, Transillumination Accessory Tip Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: Class II Product Code: NTK Dated: March 30, 2022 Received: March 31, 2022

Dear Eddie Anderson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K213482

Device Name

TIA Tip, Cariosity, Transillumination Accessory Tip, P/N 156930xx

Indications for Use (Describe)

The TIA Tip is a diagnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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E4D TECHNOLOGIES

510(k) Summary-K213482

Sponsor / 510(k) Owner 5.1

D4D Technologies, LLC (dba E4D Technologies) 2920 Telecom Parkway, Suite 100 Richardson, Texas 75082 USA Main: 972-534-3101

Contact:

Eddie Anderson Regulatory Affairs Manager Direct: 972.534.3101 Email: eanderson@e4d.com

5.2 Date Summary Prepared:

March 16, 2022

5.3 Device Name

Trade Name(s):	Cariosity; TIA Tip, Transillumination Accessory Tip
Common Name:	Caries Detector, Laser Light, Transmission
Classification Name:	Laser fluorescence caries detection device
Regulation Number:	872.1745
Product Code:	NTK
Device Class:	Class 2
Medical Specialty:	Dental

Predicate Device(s) 5.4

CamX Triton HD Proxi Head (K172007); Duerr Dental AG

5.5 Device Description

Dental Scanner .
TIA Tip ●
Computer with Software ●

The USB cable uses industry standard USB 3.0 type-A and type-C connectors, and the cable assembly is detachable making it easily replaceable.

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510(k) Summarv

The TIA tip must be connected to the scanner to work. It incorporates two "probes" containing Light Emitting Diodes (LEDs) that emit 727nm near infrared light.

The software will also allow for the capture of static images throughout the inspection process if the user wishes to document an area of interest and show the patient to discuss treatment options.

The software operates on a laptop or desktop pc. A network connection is required for interoperability.

5.5.1. Scientific Concept

The underlying scientific concept is the use of transillumination, shining light through a body area or organ to check for abnormalities. The 727nm near IR LEDs in the TIA Tip illuminate the internal layers (enamel, dentin, pulp) of a tooth and the imaging sensor in the scanner captures the images in real time. The software displays the black and white 2D transillumination images on a computer screen as a live view and can also store the images for later use. A dentist can then use the images as an aid in the detection and monitoring of caries, or other abnormalities inside the tooth.

5.6 Indications for Use

The TIA Tip is a diaqnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva.

5.7 Summary of technological characteristics / Substantial Equivalence Discussion

The following Table compares the Transillumination Accessory (TIA) Tip, P/N 156930xx to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence.

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Sec510(k) Summary

Table 5A – Comparison of Characteristics

Description	TIA Tip,P/N 156930xxK213482(Subiect Device)	CamX Triton HD ProxiHeadK172007(Predicate Device)	Device Comparison
Product Code	NTK	NTK	Same
Regulation Number	872.1745	872.1745	Same
Indications for Use	The TIA Tip is a diagnosticaid for viewing theinterproximal areas ofdental anatomy to detectand monitor theprogression of proximalcarious lesions above thegingiva.	The CamX Triton HD ProxiHead is a diagnostic aid forthe detection ofinterproximal caries lesionsabove the gingiva and formonitoring the progress ofsuch lesions.	Equivalent – Proximal andInterproximal are usedinterchangeably. Thesubject device and thepredicate device both usetransillumination to viewthe same area of the dentalanatomy and for the samepurposes. The difference isthat when viewing from theocclusal position, thesubject device projectstransilluminated light fromthe buccal/linqual positionof the tooth whereas thepredicate device projectsthe transilluminated lightfrom the occlusal positionof the teeth.
Design	Handheld device	Handheld device	Same
Functional Principle	Transillumination:Based on the principle thattooth enamel is translucentto NIR light. If the lighttransmission is interrupteddue to caries lesions a darkarea appears, in normalmode. (Inverse CamXTriton HD Proxi Head)	Transillumination:It makes use of the toothstructure which has theability of light transmission.If the light transmission isinterrupted due to carieslesions a bright areaappears.	Equivalent: Both use theprinciple oftransillumination. Thedifference is that thepredicate device indicatesthe potential carious lesionsas bright spots and the TIATip provides alternateviews in normal, invertedand color.
Device Components	Handheld device with USB,cable and software installedon a computer.	Handheld device with USB,cable and software installedon a computer.	Same
Light Source	Two LEDs are used togenerate the exactwavelength beingdetectable by the CMOSsensor.	Two LEDs are used togenerate the exactwavelength beingdetectable by the CMOSsensor.	Same
Installation	The computer-basedinstallation enables thecustomer to update thesoftware	The computer-basedinstallation enables thecustomer to update thesoftware	Same
Power Source	USB-5V	USB-5V	Same
Compatibility	USB 3.0 connection	USB connection	Same
Compliance to Standards	IEC 60601-1	IEC 60601-1	Same
Description	TIA Tip,P/N 156930xxK213482(Subject Device)	CamX Triton HD ProxiHeadK172007(Predicate Device)	Device Comparison
Cross ContaminationControl	Autoclave (tip of thedevice)The scanner body (operatorcontact) is covered with anFDA cleared disposablesheath or barrier material.	Camera cover (singlepatient disposable sheath,K132953) is placed overthe distalend, and an autoclave-ablespacer	The entire TIA Tip isautoclavable whereas thepredicate device uses acombination of a singlepatient disposable sheathtogether with anautoclavable spacer.
Available Configurations	One Configuration:Handpiece and proprietarysoftware. The handpiececan be connected via USBto a computer.	One Configuration:Handpiece and proprietarysoftware. The handpiececan be connected via USBto a computer (customerprovided).	Same
Software	The software is acomputer-based software,which is controlling:- Show / display thepictures- Store / save the pictures- Live Stream (side by sidefor transilluminated andlive color image)– Controlling of camerafunctions	The software is acomputer-based software,which is controlling:- Show / display thepictures- Store / save the pictures- Live Stream– Controlling of camerafunctions	Equivalent – the TIA Tiphas the added feature ofbeing able to show thetransilluminated live imageand the color live viewimages side by side,whereas the predicatedevice only displays the livetransilluminated image.
Intended Users	Dentist	Dentist	Same
Wavelength	727 nm	850 nm	the predicate device usesLEDs with a slightly higherwavelength. The higherwavelength will naturallypenetrate better into thetooth. However, this iseasily compensated for byadjusting the drivingcurrent for LEDs on thesubject device to achieveoptimal image quality.
Output Power	2 LED Sources(transillumination) – Max3.74mW/cm2 (1.8-1.9mW/cm² for each LED)measured at the 3.845 mmmeasuring distanceLaser (live color view) -Max 1.12mW/cm² at100mm measuring distancethrough a 7mm aperture.	2 LED sources - Max 2.00mW/cm² at 7mmmeasuring distance	Considering the differencein measuring distance of3.845 vs. 7mm, the LEDoutput power for TIA Tipand CamX Triton arealmost the same asmeasured in side-by-sidetesting using the samemeasurement equipmentand in the same testenvironment.The Laser power wasmeasured by TUV in report7169004049-100. (Seepage 17-480)
Description	TIA Tip,P/N 156930xxK213482(Subject Device)	CamX Triton HD ProxiHeadK172007(Predicate Device)	Device Comparison
Illumination Type	Pulsed Illumination –method of illumination thatconsists of periodical lightsource activation. I.e.alternating ON(pulse)/OFFstates.	Continuous Illumination –method of illumination inwhich the source isactivated continuously.	The TIA Tip uses sequentialpulses of RBG laser lightand NIR LED light toproduce side by sidetransillumination and colorlive stream images.

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D4D Technologies, LLC 510 Trounnorogios, 220

Transillumination Accessory (TIA) Tip, P/N 156930xx
Traditional 510(k) - K213482/Supplement

E4D TECHNOLOGIES

510(k) Summary

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E4D TECHNOLOGIES

510(k) Summarv

5.8 Summary of Nonclinical Performance Testing

The TIA Tip was evaluated to demonstrate substantial equivalence based on similar performance to the predicate device, the CamX Triton HD Proxi. Key performance attributes tested and compared include:

a. LED illumination and output power
b. Image Quality

Validation and verification test results showed that the subject device and the predicate device are substantially equivalent, and that illumination and image quality of potential caries detection products are similar for both Duerr Dental AG's CamX Triton HD Proxi and E4D's TIA Tip. The TIA Tip complies with the following:

. IEC 60601-1 Edition 3.1 - Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
. IEC 60601-1-2:2014 – Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
Sterilization validation was conducted in accordance with ISO 17665-1 Sterilization of Health . Care Products – Moist Heat-Part 1
. Biocompatibility Testing in accordance with the reguired parts of the ISO 10993 series; derived from the ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing

There are no known biocompatibility issues associated with any patient contact materials used to manufacture the TIA Tip. The assembled tip was tested and complies with ISO 10993-10 for Irritation and Delayed Hypersensitivity, and ISO 10993-5 for Cytotoxicity.

5.9 Summary of Clinical Testing

Clinical testing is not required and has not been performed.

5.10 Conclusion

A comparison of the indications for use, construction materials, and principle of operations, features and technical data show that the TIA Tip is safe and effective for its intended use. Evaluation of the minor technological differences between the subject device and the predicate do not raise any new issues of safety or effectiveness.

Based on similarities in indications for use and technological characteristics, together with results of non-clinical performance testing, it is concluded that the TIA Tip is substantially equivalent to the CamX Triton HD Proxi Head system.

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.