The Fluorescence Mode is an accessory to the EXTARO 300 surgical microscope to utilize a kind of LED light that illuminates the tooth surfaces in the blue light region with a narrow band ( around wavelength 405nm). The Fluorescence Mode is not a standalone device. It is a built-in feature (new components) to existing surgical microscope. These components include (1) an additional violet source in existing LED lamp, (2) a bandpass filter in existing OPMI (Operation Microscope) Head and (3) multi-function knob on existing OPMI Head.

AI/ML Overview

The provided text describes information from a 510(k) submission for the "Fluorescence Mode" device, an accessory to the EXTARO 300 surgical microscope. However, it does not contain a discrete acceptance criteria table or a detailed study report proving the device meets specific performance acceptance criteria for detecting dental caries.

The document focuses on demonstrating substantial equivalence to a predicate device (VistaCam iX "Proof" (K150672)) by comparing technological characteristics, intended use, and general performance, rather than presenting a standalone study with defined performance metrics and acceptance thresholds for the "Fluorescence Mode" itself.

Here's a breakdown of the information available based on your request, highlighting what is present and what is missing:

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

Acceptance Criteria: Not explicitly stated as a table with numerical or categorical thresholds for caries detection performance (e.g., sensitivity, specificity, accuracy). The document discusses general compliance with standards and safety.
Reported Device Performance: Instead of performance metrics for caries detection, the document reports on the successful completion of various verification and validation tests to established specifications and standards.
- Light Safety Testing: Conforms to IEC 62471:2006.
- Environmental Testing: Performance not changed after various environmental tests (temperature, simulated transportation, moisture, pressure).
- Usability Testing: Device could be used by intended users without serious errors or problems.
- System Verification Testing: All System Requirement Specifications were met (product stability, ergonomics, dimensions, image quality, image filters, light sources).
- EMC/ES Testing: Conforms to IEC 60601-1-2:2014.
- Software Verification and Validation Testing: Performed in accordance with FDA Guidance for a Moderate Level of Concern.
- Background Light Interference Verification: Expected levels of background light (40lx for CCT 4000K-6500K) do not impact device performance; carious teeth can be differentiated at 40lx and below.

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

Sample Size for Test Set:
- For Usability Testing: Total of 15 clinicians across 12 sites used the Fluorescence Mode to aid in the detection of caries in more than 40 cases in clinical practices.
- For other performance tests like Light Safety, Environmental, System Verification, EMC/ES, Software V&V, and Background Light Interference, the sample sizes are not explicitly stated in terms of patient/tooth count, but rather the tests were conducted on the device hardware/software.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The "clinical practices" mentioned for usability testing imply real-world usage, but no further details are given.

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)

The document does not explicitly describe how ground truth was established for the "more than 40 cases" in usability testing for the purpose of evaluating the carie detection performance of the device. The usability testing primarily assessed the device's usability, not its diagnostic accuracy against a definitive ground truth.
The "clinicians" involved in usability testing are dentists/users, but their role in establishing ground truth for performance evaluation is not detailed, nor are their specific qualifications provided beyond being "clinicians."

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

No adjudication method for establishing ground truth for a test set (in terms of caries detection accuracy) is described. The usability study focused on user experience and safety, not diagnostic performance adjudication.

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 is mentioned. The device is described as an "aid in the detection of dental caries," implying assistance to a dentist, but no study comparing human readers with and without the device is provided.
The device is a "Fluorescence Mode" and not explicitly stated as an "AI" device, so the comparison of improvement with AI vs. without AI assistance is not applicable here based on the provided text.

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

The document states, "The Fluorescence Mode is intended to be used by dentist as an aid in the detection of dental caries." This explicitly indicates a human-in-the-loop scenario.
No standalone (algorithm only) performance study of the "Fluorescence Mode" for caries detection is described.

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

As mentioned in point 3, the document does not specify the type of ground truth used for evaluating the device's performance in caries detection. The focus of the reported studies is on safety, usability, and system functionality. For the "more than 40 cases" in usability testing, the method of confirming actual caries presence or absence (ground truth) is not detailed.

8. The sample size for the training set

The document describes verification and validation for the "Fluorescence Mode" feature but does not mention any "training set" or "training data." This typically implies that the device is based on a deterministic physical principle (fluorescence) rather than a machine learning model that requires training data.

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

Since no training set is mentioned (as per point 8), the establishment of ground truth for a training set is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Carl Zeiss Suzhou Co., Ltd. % Mandy Ambrecht Staff Regulatory Affairs Specialist Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, California 94568

Re: K171007

Trade/Device Name: Fluorescence Mode Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: Class II Product Code: NBL Dated: April 4, 2018 Received: April 4, 2018

Dear Ms. Ambrecht:

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.

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

May 3, 2018

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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.

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 medical devices and radiation-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) K171007

Device Name

Fluorescence Mode

Indications for Use (Describe)

The Fluorescence Mode is intended to be used by dentist as an aid in the detection of dental caries

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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510(k) SUMMARY (per 21 CFR §807.92)

Fluorescence Mode

GENERAL INFORMATION

Applicant:	Carl Zeiss Suzhou Co., Ltd.Modern Industrial Square 3bNo. 333 Xing Pu Road SipSuzhou, Jiangsu 215126 China+ 86-512-8227-1388 (phone)+ 86-512-6287-1366 (fax)Establishment Registration Number: 3008564898
Contact Person:	Mandy AmbrechtStaff Regulatory Affairs SpecialistCarl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, CA 94568(925) 557-4561 PhoneE-mail: mandy.ambrecht@zeiss.com
Date Prepared:	May 3, 2018
Common Name:	Dental Fluorescence Examination Device
Classification Name:	Laser Fluorescence Caries Detection Device
Product Code and Class:	NBL — Class II
Classification Number:	21 CFR 872.1745
Trade/Proprietary Name:	Fluorescence Mode

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PREDICATE DEVICE

Company: Durr Dental AG

Device: VistaCam iX "Proof" (K150672)

lt is the opinion of Carl Zeiss Suzhou Company, Limited that the dental Fluorescence Mode of the EXTARO 300 surgical microscope is substantially equivalent to the predicate VistaCam iX "Proof" (K150672) for the intended use as an aid in the detection of dental caries .The Fluorescence Mode built-in to the surgical microscope aids in the detection of caries.

INDICATIONS FOR USE (21 CFR §807.92(a)(5))

The Fluorescence Mode is intended to be used by dentist as an aid in the detection of dental caries

DEVICE DESCRIPTION SUMMARY (21 CFR §807.92(a)(4))

CZSZ currently manufactures an optional accessory, Fluorescence Mode, to the EXTARO 300 intended to be used by dentist as an aid in the detection of dental caries.

Device Overview

The Fluorescence Mode is not a standalone device. It is a built-in feature (new components) to existing surgical microscope. These components include (1) an additional violet source in existing LED lamp, (2) a bandpass filter in existing OPMI (Operation Microscope) Head and (3) multi-function knob on existing OPMI Head.

The primary operating functions of EXTARO 300 are:

to provide a view of the surgical field with variable magnification,
to illuminate the surgical field, ।
to provide means to move the microscope to the surgical field, and,
to hold it in this position while viewing the surgical procedure.

The primary operating functions are realized by the viewing optics in the microscope, the illumination system, and the microscope stand/suspension system.

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Description of Software

Software of the EXTARO 300 surgical microscope provides the firmware control following functionalities:

Light source control l
-Filter control
। Video control
। Communication with iPad
Wi-Fi module has access control -

CZSC has implemented a software development process according to IEC 62304 for software with a Moderate Level of Concern.

Risk Management

Carl Zeiss Suzhou Co., Ltd. has implemented and maintains a risk management assessment process according to ISO 14971. This process which is defined in an internal Standard Operation Procedure was conducted on EXTARO 300.

The device labeling contains instructions for use and any necessary cautions and warnings for use of the device.

Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by software means, user instructions, verification of requirements and validation of the clinical workflow to ensure that the product meets its intended uses. To minimize electrical, mechanical and radiation hazards, ZEISS adheres to recognized and established industry practice and relevant international standards.

Technological Characteristics and Substantial Equivalence (21 CFR §807.92(a)(6)):

lt is the opinion of CZSZ that the proposed device, the dental Fluorescence Mode of the EXTARO 300 surgical microscope, is substantially equivalent to the predicate VistaCam iX "Proof" (K150672).

The indications for use for the Fluorescence Mode of the EXTARO 300 surgical microscope is similar to the indications for the predicate device VistaCam iX "Proof" (K150672).

Technological and functionalities comparisons demonstrate that the Fluorescence Mode of the EXTARO 300 surgical microscope is functionally equivalent to the primary predicate VistaCam iX "Proof" (K150672) and does not raise new questions regarding safety and effectiveness.

Non-Clinical Performance Testing (21 CFR §807.92(b)):

There were several devices identified to already be on the market which were considered similar or equivalent to Fluorescence mode based on EXTARO 300 surgical microscope. Due to non-contact operation of this fluorescence module and surgical microscope with the patient, it has a very low surgical risk profile. The verification and validation test of the Fluorescence Mode based on EXTARO 300 have generated data to provide evidence of substantial equivalence.

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The Fluorescence Mode of the EXTARO 300 surgical microscope is designed and tested to applicable standards for electrical and optical safety with established specifications. Performance testing conducted on the system was consistent to the intended use claim. The verification testing demonstrates that the device performance complies with specifications and requirements. Results of verification and validation demonstrate substantially equivalent safety and effectiveness as the predicate device; tests can be categorized into the following groups:

Device System Verification
Verification According to Harmonized/Recognized Standards
- Electromagnetic Compatibility and Electrical Safety .
- . Environmental Simulation
- Usability
Software Verification and Validation
Product Validation

Testing to Consensus Standards (21 CFR §807.92(b)(1))

The Fluorescence Mode of EXTARO 300 surgical microscope has been tested (as needed) to meet the requirements for conformity (where applicable) to multiple industry standards. The R&D evaluation of the relevant testing to consensus standards is documented and listed as below.

No.	Performance testing	Standard followed	Conclusion
1	Light Safety Testing	IEC 62471:2006/EN 62471:2008Photobiological safety of lampsand lamp systemsIEC/TR 62471-2 edition 1.02009-08 Technical ReportPhotobiological safety of lampsand lamp systems - Part 2Guidance on manufacturingrequirements relating to non-laser optical radiation safety	Testing has demonstrated thefluorescence mode conformsto the requirements of currentFDA recognized standard, IEC62471:2006 Photobiologicalsafety of lamps and lampsystems.
2	EnvironmentalTesting	N/A	The Environmental testingdemonstrated that theperformance of products werenot changed after variousenvironmental testingparameters, includingtemperature, simulatedtransportation, moisture, andpressure.
3	Usability Testing	IEC 62366-1 : 2015 Medicaldevices -- Part 1: Application ofusability engineering to medicaldevices	Usability testing demonstratedthat the device could be usedby the intended users withoutserious use errors orproblems, for the intendeduses and under the expecteduse conditions. This testinginvolved total 15 clinicians and
Performance testing	Standard followed	Conclusion
		12 sites, who usedFluorescence Mode to aid inthe detection of caries in morethan 40 cases in clinicalpractices.
System VerificationTesting	ISO 10936-1:2000 Optics andphotonics -- Operationmicroscopes -- Part 1:Requirements and test methods	System verification testingdemonstrated that all SystemRequirement Specificationswere met, including those forproduct stability, ergonomics,dimensions, image quality,image filters, and lightsources.
EMC/ES Testing	IEC 60601-1-2:2014 (4thedition) - Medical electricalequipment - Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral Standard:Electromagnetic disturbances -Requirements and tests	The device conforms to IEC60601-1-2:2014 (4th edition)and the requirements ofcurrent FDA recognizedstandard, IEC 60601-1-2Edition 4.0 2014-02 Medicalelectrical equipment - Part 1-2: General requirements forbasic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances - Requirementsand tests.Essential performancerequirements have been metand documented.
Software Verificationand ValidationTesting	N/A	Software V&V was performedin accordance with FDAGuidance for the Content ofPremarket Submissions forSoftware Contained in MedicalDevices for a device ofModerate Level of Concern.
Background lightinterferenceverification.	N/A	Testing demonstrated thatexpected levels of backgroundlight do not impact theperformance of the device. Alight intensity of 40lx for CCT4000K-6500K light wasselected as an acceptable levelof background light in theexam room. Testing across thespectrum of 4000k-6500kbackground light sources hasdemonstrated that the cariousteeth can be differentiated at

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No.

40lx and below.

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Substantial Equivalence to Predicates (21 CFR §807.92(b)(1))

Verification testing to the system requirements (SRS) for the Fluorescence Mode and the validation of the intended use is intended to support the claim of substantial equivalence to the following Substantial Equivalence table:

Table 1: Substantial Equivalence Table (abbreviated)

Device	The Fluorescence Mode(Proposed Device)	VistaCam iX "Proof" (K150672)
Intended Use	The Fluorescence Mode is intended to be used bydentist as an aid in the detection of dental caries	Caries detection aid
Indication forUse	The Fluorescence Mode is intended to be used bydentist as an aid in the detection of dental caries.	The VistaCam iX "Proof" is intended to be used asan aid in the detection and diagnosis of dentalcaries
DeviceClassificationName	Laser Fluorescence Caries Detection	Laser Fluorescence Caries Detection
GenericCommon Name	Dental Fluorescence Examination Device	Intraoral Camera with Fluorescence CariesDetection Aid
ClassificationProduct Code	NBL	NBL
Class	II	II
Technology	Fluorescence technology to aid in the detection ofcarious lesions	Fluorescence technology to aid in the detectionof carious lesions
Mode ofOperation	Excites bacteria to fluoresce	Excites bacteria to fluoresce
DetectionWavelength	405 nm	405 nm (Proof interchangeable head)
Differences:
DeviceOperatingFeature	Dental microscope with built-in feature providesvisualization and an uninterrupted workflow	Headpiece with control buttons
Software	Software of Surgical Microscope:• Light Source Control• Filter Control• Video Control• Wi-Fi Module: Firmware processes networkcommunication	Using DBSWIN Imaging Software

The above table shows that these two devices are similar in the technological characteristics, the intended use, and the performances in detecting dental caries. Details of the Substantial Equivalence Discussion and comparison chart are in Section 12.

The differences between the subject device and the predicate device are supported by performance data and do not raise any new questions about safety and effectiveness. The device can therefore be considered substantially equivalent to the predicate device.

510(k) Summary (21 CFR §807.92(c))

As described in this 510(k) Summary, all testing deemed necessary was conducted on the Fluorescence Mode of the EXTARO 300 surgical microscope to ensure that the device is substantially equivalent to the predicate in terms of safety and effectiveness for its intended use when used in accordance with its Instructions for Use.

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.