The CamX Triton HD Proxi Head is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.

Device Description

The CamX Triton HD "Proxi" aids in the detection and diagnosis of proximal caries. It consists of a toothbrush-sized handpiece and a "Proxi" head. A USB cable connects the handpiece to a personal computer with PACS software such as DBSWIN to enable communication between a PC computer and the handpiece. After a camera cover (single patient disposable sheath, K132953) is placed over the distal end, and an autoclave-able spacer is installed, the Handpiece is positioned over the teeth to be examined. The camera functions by transilluminating sound tooth enamel with infrared light. Areas that spread and reflect the light (e.g. caries lesions) show up clearly delimited bright areas. A digital camera converts the object situation into an electrical signal, sent it over USB to a computer, converted into an image (by imaging software) and presented on a monitor in monochrome colors to illustrate suspected areas of decay.

AI/ML Overview

This document is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria through a clinical study. Therefore, comprehensive information regarding acceptance criteria and a detailed study proving the device meets them, as typically found in a clinical trial report, is not present.

However, based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative table format with corresponding performance results. Instead, it relies on a comparison to the predicate device and validation of key performance attributes.

Acceptance Criteria (Inferred from non-clinical testing)	Reported Device Performance
LED Illumination and output (similar to predicate)	Validation and verification test results showed that new device and the predicate device are equivalent.
Image Quality (similar to predicate)	Illumination and image quality of potential caries detection products are similar for both Duerr Dental AG's CamX Triton HD Proxi and KaVo's DIAGNOcam camera.
Compliance with Standards	Duerr Dental AG's CamX Triton HD Proxi complies with IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (edition 3), IEC 60601-1-2:2014 (edition 4), and IEC 80601-2-60:2012 (first edition).
Sterilization Validation	Sterilization validation testing was successfully performed according to ANSI/AAMI/ISO 17665-1, Annex D and the validation approach outlined in ANSI/AAMI/ISO 14937, Annex D (Approach 3).
Biocompatibility (for patient-contacting components)	Patient contact Distance Spacer component was tested and complies with ISO 10993-10:2002 Standard and Amendment 1, and ISO 10993-5. (Other components isolated from patient contact).
Functional Principle (transillumination)	The main function is based on transillumination, same as the predicate devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document explicitly states: "11. Clinical Data: Not required for a finding of substantial equivalence." This means a clinical test set of patient data, as would be used in a typical clinical study, was not required or performed for this submission. The performance assessment was based on non-clinical data.

3. 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)

Given that clinical data was not required, there is no mention of experts establishing ground truth for a clinical test set. The "ground truth" concept in a clinical context (e.g., confirmed caries presence) is not applicable here as no clinical study was performed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring adjudication was used.

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

Not applicable. This is a device for detecting caries, not an AI-assisted diagnostic tool for human readers in the context of an MRMC study.

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

The device is described as "a diagnostic aid," implying human-in-the-loop use. The primary mode of operation described is a digital camera converting the object situation into an electrical signal, sent to a computer, converted into an image, and "presented on a monitor in monochrome colors to illustrate suspected areas of decay." This suggests the image is then interpreted by a dentist. A standalone algorithm performance was not reported.

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

For the non-clinical testing of "illumination and image quality," the ground truth implicitly would be objective measurements and comparisons against the predicate device's characteristics and output. For biocompatibility and sterilization, the ground truth is adherence to established international standards and successful completion of specified tests.

8. The sample size for the training set

Not applicable. This device does not appear to be an AI/machine learning product that would require a "training set" in the conventional sense. Its function is based on transillumination and image capture.

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

Not applicable, as there is no mention of a training set for an AI/machine learning model.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 22, 2017

Duerr Dental AG % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114

Re: K172007

Trade/Device Name: CamX Triton HD Proxi Head Regulation Number: 21 CFR 872.1745 Regulation Name: Laser fluorescence caries detection device Regulatory Class: Class II Product Code: NTK Dated: October 5, 2017 Received: October 10, 2017

Dear Daniel Kamm:

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 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mary S. Runner -S

For Tina Kiang, Ph.D. 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) K172007

Device Name CamX Triton HD Proxi Head

Indications for Use (Describe)

The CamX Triton HD Proxi Head is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary, DUERR DENTAL AG, CamX Triton HD Proxi Head K172007

This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92.

Date Summary Prepared: 1.

September 21, 2017

2. Submitter's Identification:

DUERR DENTAL AG Höpfigheimer Strasse 17 74321 Bietigheim-Bissingen Deutschland/Germany Phone: + 49 (0) 7142 70 5-0 Fax: + 49 (0) 7142 705-500 E-Mail info@duerr.de Internet: www.duerrdental.com

Contact:

Oliver Lange Head of Quality Management DUERR Dental AG Höpfigheimer Strasse 17 D-74321 Bietigheim-Bissingen Deutschland / Germany Phone: + 49 (0) 7142 / 705-0 Fax: + 49 (0) 7142 / 705-500 Email: lange.o@duerr.de

U.S. Contact:

Suzanne Lucas Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747 Tel: 516-214-5514 Email: slucas@airtechniques.com

3. Device:

Trade /Proprietary Name: Device: Regulation Description: Medical Specialty: Product Code: NTK Regulation Number: Device Class: 2

CamX Triton HD Proxi Head Caries Detector, Laser Light, Transmission Laser fluorescence caries detection device. Dental 872.1745

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4. Predicate Devices:

DIAGNOcam 2170 (K123402); Kaltenbach & Voigt GmbH,
DIFOTI USB2.0 System (K043068), ELECTRO-OPTICAL SCIENCES, INC.
Transillumination Cable Ti2200 K071429), Sybron Dental Specialties, Inc
For all of these predicates:
Device:	Caries Detector, Laser Light, Transmission
Regulation Description:	Laser fluorescence caries detection device.
Medical Specialty:	Dental
Product Code:	NTK
Regulation Number:	872.1745
Device Class:	2

5. Device Description:

After a camera cover (single patient disposable sheath, K132953) is placed over the distal end, and an autoclave-able spacer is installed, the Handpiece is positioned over the teeth to be examined. The camera functions by transilluminating sound tooth enamel with infrared light. Areas that spread and reflect the light (e.g. caries lesions) show up clearly delimited bright areas. A digital camera converts the object situation into an electrical signal, sent it over USB to a computer, converted into an image (by imaging software) and presented on a monitor in monochrome colors to illustrate suspected areas of decay.

6. Indications for use:

The CamX Triton HD Proxi Head is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.

7. Summary of the technological characteristics of the device compared to the predicate devices:

Duerr Dental's CamX Triton HD Proxi Head is substantially equivalent in terms of indications for use and the technology to the predicate devices which are currently in commercial distribution.

Table 1 below, summarizes the technological characteristics of CamX Triton HD Proxi Head vs. the predicate devices.

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Summary of the Technological Characteristics

DescriptiveInformation	CamX Triton HD Proxi Head (newproduct)	DIAGNOcam 2170(K123402)	DIFOTI USB 2.0 System(K043068)	TransilluminationCable TI2200(K071429)
Indication for Use	The CamX Triton HD Proxi Head is adiagnostic aid for the detection ofinterproximal caries lesions abovethe gingiva and for monitoring theprogress of such lesions	The DIAGNOcam 2170 is adiagnostic aid for the detection ofopen or incipient caries lesionsabove the gingiva and formonitoring the progress of suchlesions.Indications:- Detection of smooth surfacecaries- Detection of occlusal caries- Detection of proximal caries- Detection of secondary caries- Detection of cracks	The DIFOTI USB 2.0 System (DIFOTISystem for Dental Examinations,Model B) is indicated for detectionof frank or incipient caries lesionsabove the gum line, and formonitoring the progression of suchlesions.	The TI2200Transillumination Cable is adiagnostic aid used tolocate decay, calculus,fracture lines, endodonticorifices, cracks and fissuresunderneath the toothsurface utilizing a fiberoptic cable and handleattached to a light source
Design	Handheld device	Identical	Identical	Identical
FunctionalPrinciple	TransilluminationIt makes use of the tooth structurewhich has the ability of lighttransmission. If the lighttransmission is interrupted due tocaries lesions a bright area appears(inverse to e.g.DIAGNOcam 2170)	TransilluminationIt makes use of the tooth structurewhich has the ability of lighttransmission. If the lighttransmission is interrupted due tocaries lesions a dark shadowappears.	TransilluminationIt makes use of the tooth structurewhich has the ability of lighttransmission. If the lighttransmission is interrupted due tocaries lesions a dark shadowappears.	TransilluminationIt makes use of the toothstructure which has theability of light transmission.If the light transmission isinterrupted due to carieslesions a dark shadowappears.
DeviceComponents	Handheld device with USBcable and software	Identical	Identical	Handheld device withcable and unit.
DescriptiveInformation	CamX Triton HD Proxi Head (newproduct)	DIAGNOcam 2170(K123402)	DIFOTI USB 2.0 System(K043068)	TransilluminationCable TI2200(K071429)
Light Source	Two LED are used to generate theexact wavelength being detectableby the CMOS sensor.	An internal laser diode is used togenerate the exact wavelengthbeing detectable by the CCDsensor.	An internal laser diode is used togenerate the exact wavelengthbeing detectable by the CCDsensor.	External light source
Installation	The computer basedinstallation enables thecustomer to update thesoftware	The computer based installationenables the customer to updatethe firm- and software	The computer based installationenables the customer to updatethe firm- and software	Independent (nosoftware)
Power Source	USB-5V	Identical	Identical	N/A
Compatibility	USB connection	Identical	Identical	Specific connection
Compliance toStandards	IEC 60601-1	IEC60601-1, UL60601-1	IEC60601-1, UL60601-1	Not specified
Autoclaveable	Yes (distance spacer of theproduct)	Yes (tip of the product)	No (tip of the product isdisposable)	No
Portable	No	Identical	Identical	Identical
Software	The software is a computerbased software, which iscontrolling:- Show / display the pictures- Store / save the pictures- Live stream- Steering of camera function	The software consists of aproduct firmware and acomputer based software,which is controlling:- Show / display the pictures- Store / save the pictures- Life stream- Steering of camera function	The software consists of aproduct firmware and acomputer based software,which is controlling:- Show / display the pictures- Store / save the pictures- Life stream- Steering of camera function	No software
Intended Users	Dentist	Identical	Identical	Identical
Wavelength	850 nm	788 nm	670 nm	Not specified
Output power	2 sources (together ~4,5mW)max. 4,1 mW / cm² at a distanceof 7 mm (spacer)	2 sources (each ~2mW)max. 21 mW / cm²	2 sources (left side ~1mW,right side ~3mW) max. 41mW/cm²	Not specified

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8. Discussion of Differences:

i. Functional Principle: The main function is based on transillumination, same as the predicate devices. The only difference is the image information of the CamX Triton HD Proxi is displayed inverted in comparison to the predicate devices.
ii. Light source : CamX Triton HD Proxi uses 2 infrared LEDs whereas other devices use a laser light source. The difference has geometrical and constructional/ design reasons. The predicate devices use light guides to bring the laser light to the tooth surface, in contrast to the CamX Triton HD Proxi has a direct illumination by LED in the distal end.
iii. Wavelength: The wavelength which is used (850 nm) is a little bit higher than the wavelength used by the predicate devices. The wavelength of the CamX Triton HD Proxi is optimized for the ability of light transmission of the sound enamel and for the sensitivity of the used CMOS image sensor.
iv. Output power: The output power for CamX Triton HD Proxi is 4,5 mW and for DIAGNOcam and DIFOTI the output power is about 4 mW (the two sources in addition, each).

9. Non-Clinical Data and Performance Testing

The purpose of the evaluation was to demonstrate substantial equivalence based on similar performance between the new device, the CamX Triton HD Proxi and latest predicate device, DIAGNOcam 2170. Key performance attributes tested and compared include:

a. LED Illumination and output
b. Image Quality

Validation and verification test results showed that new device and the predicate device are 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 KaVo's DIAGNOcam camera. Duerr Dental AG's CamX Triton HD Proxi complies with IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (edition 3) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2:2014 (edition 4) - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, and IEC 80601-2-60:2012 (first edition) Medical electrical equipment - Part 2-60: Particular requirements for basic safety and essential performance of dental equipment. Sterilization validation testing was successfully performed according to ANSI/AAMI/ISO 17665-1, Annex D and the validation approach outlined in ANSI/AAMI/ISO 14937, Annex D (Approach 3).

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10. Biocompatibility Assessment

There are no biocompatibility issues known to be associated with any of the materials used to manufacture the CamX Triton HD Proxi. Patient contact Distance Spacer component was tested and complies with ISO 10993- 10:2002 Standard and Amendment 1, "Biological Evaluation of Medical Devices, Part 10-Tests for Irritation and Delayed-Type Hypersensitivity", and ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity. By design, many of the components of the CamX Triton HD Proxi are isolated from patient contact by a camera cover and through a distance spacer. Components that have no patient contact are:

Hand piece housing ●
Lens window-
Handpiece control buttons -
Umbilical -

Components that contact the patient are:

Camera cover*
8 mm Spacer*

*These materials are currently in use and market distribution with the similar device "Spectra Fluorescence Caries Detection Aid System" device, 510K# K090169.

1. Clinical Data: Not required for a finding of substantial equivalence.

12. Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate device in terms of technology, performance and indications for use, Duerr Dental AG concludes that the CamX Triton HD Proxi is substantially equivalent to the predicate device as described herein.

The differences between the new device and the predicate device shown in the comparison table above do not raise any new questions about safety and effectiveness and so we consider it substantially equivalent to the predicate device.

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.