The VistaCam iX "Proof" aids in the detection and diagnosis of caries. It consists of a toothbrush-sized handpiece and a "Proof" 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 is placed over the distal end, and an autoclave-able spacer is installed, the Handpiece is positioned over the tooth to be examined. The camera functions by illuminating the tooth surface with a light that causes the bacteria resident in carries to fluoresce. The fluoresced light is then converted into an electrical signal, sent to a computer, converted into an image (by imaging software) and presented on a monitor in multiple colors to illustrate suspected areas of decay.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the VistaCam iX "Proof" device, formatted to answer your questions.

It's important to note that this document is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive standalone clinical trial. Therefore, detailed information on certain aspects you asked for (like MRMC study effect sizes or ground truth establishment for a training set) might not be explicitly present if the submission relies heavily on non-clinical comparative data.

Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence to a predicate device (Air Techniques' Spectra Fluorescence Caries Detection Aid Device, 510K# K090169). Therefore, the "acceptance criteria" are implicitly tied to demonstrating similar performance attributes rather than a specific clinical performance metric like sensitivity or specificity.

Table 1: Acceptance Criteria and Reported Device Performance

Performance Attribute	Acceptance Criteria (Implicitly based on Predicate)	Reported Device Performance (VistaCam iX "Proof")
LED Illumination	Similar to predicate device	Equivalent: "illumination and fluorescence of potential caries detection products are similar for both Dürr Dental AG's VistaCam iX "Proof" and Air Techniques' Spectra camera." (Page 8)
Output	Similar to predicate device	Equivalent: "illumination and fluorescence of potential caries detection products are similar for both Dürr Dental AG's VistaCam iX "Proof" and Air Techniques' Spectra camera." (Page 8)
Image Quality	Similar to predicate device	Equivalent: "Validation and verification test results showed that new device and the predicate device are equivalent..." (Page 8)
Color Separation	Similar to predicate device	Equivalent: "Validation and verification test results showed that new device and the predicate device are equivalent..." (Page 8)
Intensity	Performance not impacted by intensity difference	"The difference in intensity of these devices does not impact VistaCam iX "Proof's" performance, safety and effectiveness. VistaCam iX's performance is demonstrated in the Executed validation report." (Page 6)
Light source/Lens	Performance not impacted by difference in count	"This difference in number of LEDs and lenses does not impact device's performance. VistaCam iX "Proof's" performance is demonstrated in the Executed validation report." (Page 7)
Software	Compatibility with DBSWIN imaging software	"The compatibility of VistaCam iX "Proof" and DBSWIN is demonstrated by the DBSWIN software documents that are provided." (Page 7)
System Function	Functionality as a caries detection aid	"The VistaCam iX "Proof" aids in the detection and diagnosis of caries." (Page 4)
Safety	Compliance with relevant electrical and medical device safety standards; biocompatibility	Fully complies with IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, ISO 10993-10, ISO 10993-5. (Pages 6, 8, 9)
Sterilization	Spacers sterilization validity	Sterilization validation study performed on 10 mm Spectra spacers (similar to 8mm VistaCam iX "Proof" spacers) per ISO 11134:1994, validated by Nelson laboratories to current FDA recognized standard ISO 17665-1. (Page 7)

Study Details

Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a clinical "test set" in terms of patients or lesions. The studies mentioned are primarily non-clinical validation and verification tests comparing the new device to the predicate device in terms of LED illumination, output, image quality, and color separation.
- The data provenance is not explicitly stated as country of origin, nor is it classified as retrospective or prospective clinical data, as this is a non-clinical equivalence submission for performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the submission relies on non-clinical performance comparison rather than a clinical study requiring expert-established ground truth on patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided as there is no described clinical test set with human adjudication.
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, an MRMC comparative effectiveness study was not done. This device is a "Laser Fluorescence Caries Detection Device," not an AI-based system. The submission focuses on comparing its physical and functional characteristics to a predicate device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable in the context of an AI algorithm, as this device is a hardware-based fluorescence detection system. The "algorithm" mentioned (page 7) refers to the image processing algorithm for fluorescence ratios, which is the same as the predicate device. The performance evaluated was the device's ability to produce similar illumination, output, image quality, and color separation to the predicate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance tests (LED illumination, output, image quality, color separation), the "ground truth" was effectively the established performance characteristics of the predicate device. The new device had to demonstrate performance "similar" or "equivalent" to the predicate.
- For biocompatibility, the ground truth was compliance with ISO 10993 standards.
- For electrical safety, the ground truth was compliance with IEC 60601 standards.
The sample size for the training set:
- This information is not applicable as the document describes a hardware device using fluorescence technology and a shared image processing algorithm (the same as the predicate), not a machine learning or AI model that requires a training set.
How the ground truth for the training set was established:
- This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set).

Summary

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

September 8, 2016

Durr Dental Ag % Ms. Suzanne Lucas Air Techniques, Inc 1296 Walt Techniques, Inc Melville, New York 11747

Re: K150672

Trade/Device Name: VistaCam iX "Proof" Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: April 24, 2015 Received: May 26, 2015

Dear Ms. Lucas:

This letter corrects our substantially equivalent letter of January 27, 2016

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 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 Industry and Consumer Education 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" (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 Industry and Consumer Education 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.

Sincerelv.

Susan Runno DDS, mA

Tina Kiang, Ph.D Acting Division Director Science and Policy 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K150672

Device Name VistaCam iX "Proof"

Indications for Use (Describe)

The VistaCam iX "Proof" is intended to be used as an aid in the detection and diagnosis of dental caries.

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

[X] Prescription Use (Part 21 CFR 801 Subpart D)
[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

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

1. Date Summary Prepared:

January 21, 2016

2. Submitter's Identification:

DÜRR DENTAL AG Höpfigheimer Strasse 17 74321 Bietigheim-Bissingen Deutschland/Germany Telefon: (0 71 42) 70 5-0 Telefax: (0 71 42) 705-500 E-Mail info@duerr.de Internet: www.duerrdental.com

Contact:

Oliver Lange Email: lange.o@@duerr.de Head of Quality Management DÜRR 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:	VistaCam iX "Proof"
Common Name:	Intraoral Camera with Fluorescence Caries Detection
	Aid
Classification:	21 CFR 872.1745; Laser Fluorescence Caries Detection
	Aid
Product Code:	NBL

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Predicate Device: 4.

Spectra Fluorescence Caries Detection Aid Device by Air Techniques, Inc. 510K# K090169

5. Device Description:

6. Indications for use:

The VistaCam iX "Proof" is intended to be used as an aid in the detection and diagnosis of dental caries.

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

Dürr Dental's VistaCam iX "Proof" is identical in terms of indications for use and the technology to the Spectra caries detection aid manufactured by Air Techniques'. Whose predicate dental devices are currently in commercial distribution and US-FDA cleared under 510K #K090169.

Table 1 below, summarizes the technological characteristics of VistaCam iX "Proof" vs. the predicate device.

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Table 1: Comparison to the Predicate device:

Comparison criteria	New deviceVistaCam iX "Proof"510K # K150672	Predicate deviceAir Technique's SpectraFluorescence CariesDetection Device510K #K090169
Owner/ Operator	Dürr Dental AG	Dürr Dental AG
Manufacturer	Dürr Dental AG	Air Techniques, Inc
Similarities
Intended use	Caries detection aid	Caries detection aid
Indications for use	The VistaCam iX "Proof" isintended to be used as an aid inthe detection and diagnosis ofdental caries.	The Spectra is indicated as anaid in the detection anddiagnosis of dental caries.
Technology	Fluorescence technology to aidin the detection of cariouslesions	Fluorescence technology to aidin the detection of cariouslesions
Mode of operation	Excites bacteria to fluoresce	Excites bacteria to fluoresce
Image evaluation	Same as predicate	Image ColorRelative levelGreen: 0 - 1.0Blue: 1.0 - 1.5Red 1.5 - 2.0Orange 2.0 - 2.5Yellow 2.5 - 3.0Lighter colors and highernumbers indicate an increasingmagnitude of the red / greenfluorescence ratio and thelikelihood of poorer toothhealth.
Detection wavelength	495 nm	495 nm
Power Supply	Uses power from PC USB port	Uses power from PC USB port
Returned light	Fluorescence	Fluorescence
Differences:
Enclosure	ASA+PC (Acrylonitrile StyreneAcrylate + Polycarbonate)	ABS (Acrylonitrile ButadieneStyrene) Plastic
Intensity	3 mW/cm squared at 8mm	3.5 mW/cm squared at 10mm
Light source	Utilizes 4 Violet LEDs with lightcollecting lens.	Utilizes 6 Violet LEDs with lightcollecting lens.
Comparison criteria	New deviceVistaCam iX "Proof"510K # K150672	Predicate deviceAir Technique's SpectraFluorescence CariesDetection Device510K #K090169
Software:	VistaCam iX "Proof" driversoftware and DBSWIN.VistaCam iX "Proof" can onlybe used with DBSWIN imagingsoftware	ATI Spectra driver software andVisix.
Operating	10-40 C	10-40 C
environment	20 to 75% RH non-condensing	10 to 90% RH non-condensing
Length	7.48 inches	8.6 inches
Width	1.03 inches	0.87 inches
Height	1.03 inches	1.15 inches
Spacers	8 mm	10 mm

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Discussion of Differences: 8.

i. Enclosure: The material of composition for VistaCam iX "Proof" is substantially equivalent to that of Spectra enclosure as both these materials are non-carcinogenic and poses no health hazards as per their MSDSs. The enclosure of the VistaCam iX "Proof" was safety tested by Intertek to IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007), Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The enclosure of the Spectra was safety tested by Underwriters Laboratory to IEC 60601-1:1988 +A1:1991 +A2:1995, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- ii. Intensity: The intensity for VistaCam iX is 3 mW/cm squared at 8mm and for Spectra is 3.5 mW/cm squared at 10mm. The difference in intensity of these devices does not impact VistaCam iX "Proof's" performance, safety and effectiveness. VistaCam iX's performance is demonstrated in the document - Executed validation report.
- Light source and Lens: VistaCam iX "Proof" uses 4 violet LEDs and 2 iii. lenses whereas Spectra use 6 violet LEDs and 4 lenses. The difference in the number of lenses and LED's has geometrical and constructional/ design reasons.

The function of lens is to focus the image of an object (surface of a tooth) onto the image sensor (CCD). As the "Proof" spacers are "shorter" (8mm), the camera and thus the image sensor is closer to the surface

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during image capturing. Therefore less lenses and LED's are needed for gaining a similar picture section and image quality. Most importantly, for both cameras, the recorded object area is nearly the same for the given distance, which is defined by the spacer.This difference in number of LEDs and lenses does not impact device's performance. VistaCam iX "Proof's" performance is demonstrated in the document - Executed validation report.

iv. Software: VistaCam iX "Proof" works with VistaCam iX "Proof" driver software and Spectra device works with ATI Spectra driver software. Both VistaCam iX "Proof" and Spectra uses same algorithm developed for VistaCam iX by Duerr. VistaCam iX "Proof" can only be used with DBSWIN imaging software as opposed to Visix for Spectra. The compatibility of VistaCam iX "Proof" and DBSWIN is demonstrated by the DBSWIN software documents that are provided.
Operating environment: The difference in the limits for relative humidity V. for VistaCam iX and Spectra is very minor and has no impact on the substantial equivalence of VistaCam iX.
vi. Spacers: The 8 mm spacers for VistaCam iX "Proof" are exactly the same as the 10 mm spacers for Spectra in terms of shape and material* of construction. Moreover these are purchased from the same supplier. The 2 mm difference in the size of these spacers is not a significant change in their dimensions and thus has no impact on their performance and/or sterilization characteristics. The Sterilization validation study was performed on the 10 mm Spectra spacers in 2009 per ISO 11134:1994. Sterilization of health care products -- Requirements for validation and routine control -- Industrial moist heat sterilization, by Nelson laboratories. Nelson has provided their rationale dated October 27, 2015 to support the validity of the Sterilization for Spectra Spacers performed to ISO 11134:1994 in 2009 and it's conformance to the requirements of current FDA recognized standard, ISO 17665-1. Sterilization of health care products moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.

*Septon plus a UV stabilizer (2-5-chloro-2H-benzotriazole-2-yl)-6-(1,1dimethylethyl)- 4-methylphenol (CAS-No. 3896-11-5) with the restriction SML(T) =30 mg/kg.

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Non-Clinical Data 9.

The purpose of the evaluation was to demonstrate substantial equivalence based on similar performance between the new device, the VistaCam iX "Proof"and the predicate device, Spectra Fluorescence Caries Detection Aid. Kev performance attributes tested and compared include:

a. LED Illumination and output
b. Image Quality
c. Color Separation

Validation and verification test results showed that new device and the predicate device are equivalent, and that illumination and fluorescence of potential caries detection products are similar for both Dürr Dental AG's VistaCam iX "Proof" and Air Techniques' Spectra camera.

10. Performance Testing

Dürr Dental AG's VistaCam iX "Proof" complies with IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (30 edition) - Medical electrical equipment -Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2:2014 (4" edition) - 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.

11. Biocompatibility Assessment

There is no biocompatibility issues known to be associated with any of the materials used to manufacture the VistaCam iX "Proof". 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 VistaCam iX "Proof" are isolated from patient contact by a camera cover or through a distance spacer. Components that have no patient contact are:

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Hand piece housing ASA+PC (Acrylonitrile Styrene Acrylate + ● Polycarbonate)
Lens window- Glass* .
Handpiece control buttons Polyester ●
Umbilical Silicone .

Components that contact the patient are:

Camera cover* Ethylene methyl acrylate copolymer and low density polyethylene
8 mm Spacer* ●
- Septon plus a UV stabilizer (2-5-chloro-2H-benzotriazole-2-yl)-6-(1,1-dimethylethyl)- 4-methylphenol (CAS-No. 3896-11-5) with the restriction SML(T) =30 mg/kg

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

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, Dürr Dental AG concludes that the VistaCam iX "Proof" 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.