This submission is for a modification of a device system cleared under K983658, the DIAGNOdent® 2095. The modification is in the form of a new method of packaging the device, in the form of a pen-like device instead of the former electronic unit with a fiber optic probe.

AI/ML Overview

The provided 510(k) summary for the KaVo DIAGNOdent® 2190 does not contain specific acceptance criteria or a detailed study report proving the device meets acceptance criteria. The document states that the conclusion of substantial equivalence is "based on indications for use, bench, invitro, and clinical studies, as well as EMC and electrical safety testing," but it does not provide the details of these studies or the performance metrics used.

Therefore, I cannot fulfill your request for detailed information on acceptance criteria, sample sizes, expert qualifications, or specific study designs as this information is not present in the provided text.

Based solely on the provided text, the following information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in the document. The document lists a comparison of general characteristics between the predicate (DIAGNOdent® 2095) and the new device (DIAGNOdent® 2190), indicating that for most aspects, the new device is "SAME" or has minor modifications (e.g., integrated probe, slightly different laser power, LCD numbers instead of LED numbers).

Comparison Areas	Predicate (DIAGNOdent® 2095)	DIAGNOdent® 2190
Indications for use	For use as an aid in the Diagnosis of Dental Caries	SAME
Probe technology	Fiber Optic with sapphire tip.	Probe is integrated into the body of the hand held unit, with sapphire tip.
Light Source	655 nm <1 mw Laser	650 nm, 190 nw maximum average radiant power
Laser power class	Class II	Class I
Returned light	Fluorescence	Fluorescence
Sterilization	Probe tip only, autoclave	SAME
User interface	Numeric and audible tones LED numbers	SAME except LCD numbers
Power source	6- AA Alkaline battery	1- AA Alkaline battery
Target population	Dentists' offices	SAME

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

Not provided in the document.

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

Not provided in the document.

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

Not provided in the document.

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 provided in the document. The device is a "Laser Fluorescence Caries Detection Device," which aids in diagnosis. It's not explicitly an AI-assisted diagnostic tool in the sense of image interpretation.

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

Not provided in the document. However, as it's a diagnostic aid for human use, it is designed for human-in-the-loop performance.

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

Not provided in the document. The general indication for use is "as an aid in the diagnosis of dental caries." The specific methods for confirming caries in the study are not mentioned.

8. The sample size for the training set:

Not applicable, as no algorithm training is described for this device, which appears to be a hardware device measuring fluorescence.

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

Not applicable.

Summary

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K051909

0CT 2 1 2005

EXHIBIT 2 510(k) Summary KaVo Dental Corporation 340 East Main Street Lake Zurich, Illinois 60047 Toll Free: 800 323 8029 Tel: 847 / 550 - 6800 Fax: 847 / 550 - 6825 e-mail: info@kavousa.com Contact: John Miller, Director of RA/QA July 11, 2005

1. Identification of the Device: Proprietary-Trade Name: KaVo DIAGNOdent® 2190 Classification Name: Dental Hand Instrument, Laser Fluorescence Caries Detection Device, Product Codes NTK Common/Usual Name: Laser fluorescence caries detection device
1. Equivalent legally marketed device: DIAGNOdent® 2095, K983658.
1. Indications for Use (intended use): For use as an aid in the diagnosis of dental caries.
1. Description of the Device: This submission is for a modification of a device system cleared under K983658, the DIAGNOdent® 2095. The modification is in the form of a new method of packaging the device, in the form of a pen-like device instead of the former electronic unit with a fiber optic probe.

Image /page/0/Picture/7 description: The image shows two different DIAGNOdent devices. On the left is the Predicate DIAGNOdent 2095, which has a screen and a probe. On the right is the DIAGNOdent 2190, which is a handheld device with a screen. Both devices are used for dental diagnostics.

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1. Safety and Effectiveness, comparison to predicate device:

ComparisonAreas	DIAGNOdent® 2095,K983658	DIAGNOdent® 2190
Indicationsfor use	For use as an aid in theDiagnosis of Dental Caries	SAME
Probetechnology	Fiber Optic with sapphiretip.	Probe is integrated intothe body of the hand heldunit, with sapphire tip.
Light Source	655 nm <1 mw Laser	650 nm, 190 nwmaximum average radiantpower
Laserpowerclass	Class II	Class I
Returnedlight	Fluorescence	Fluorescence
Sterilization	Probe tip only, autoclave	SAME
User interface	Numeric and audible tonesLED numbers	SAME exceptLCD numbers
Power source	6- AA Alkaline battery	1- AA Alkaline battery
Targetpopulation	Dentists' offices	SAME

1. Conclusion: In all important respects, the DIAGNOdent® 2190 is substantially equivalent to the DIAGNOdent® K983658. This conclusion is based on indications for use, bench, invitro, and clinical studies, as well as EMC and electrical safety testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.

Public Health Service

OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KAVO AMERICA C/O Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deer Field, Illinois 60015

Re: K051909

Trade/Device Name: DIAGNODENT Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence caries detection device Regulatory Class: II Product Code: NBL Dated: October 12, 2005 Received: October 13, 2005

Dear Mr. 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 releveloca doors and have be 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 Amendinents, or to arrested Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvial applicions of the Act. The general controls provisions of the Act include controls provisions of a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III 11 your dovice is classified (See a siditional controls. Existing major regulations affecting (1 writ), it hay be do adjoco in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device tan as roublish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Kamm

Please be advised that FDA's issuance of a substantial equivalence determination does not I least be auvrsou that 122 a determination that your device complies with other requirements modified in any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal bara suirements, including, but not limited to: registration 1 ou must comply with an also 120 cross and 801); good manufacturing practice and houng (21 OF RT rate 001), systems (QS) regulation (21 CFR Part 820); and if requirements us sectionic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in your be rinding of substantial equivalence of your device to a premaired predicated. - I a device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific ad riod for your at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Driber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Supti y. Michael Oms

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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):_K051909

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

For use as an aid in the diagnosis of dental caries.

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runpe

Suision Sign-Off) Olvision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K051105

Page 1 of 1

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.