This submission is for a handheld dental caries detection device which uses the AC impedance spectroscopy technique (ACIST). Single use disposal sensors are connected to the handheld device. The sensor is placed on the tooth site to be measured and a metal lip hook is placed on the patients lip, a small electrical current is passed between the sensor and the lip hook, the signals returned indicate any mineral changes in the tooth structure.

AI/ML Overview

The CarieScan PRO is a handheld dental caries detection device that uses AC impedance spectroscopy. The device's performance was compared to a predicate device, DIAGNOdent 2095, which uses laser fluorescence.

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Predicate: DIAGNOdent 2095)	Reported Device Performance (CarieScan PRO)
Sensitivity	80%	92.5%
Specificity	52%	92.5%

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the CarieScan PRO's performance data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted, nor does it report any effect size for human readers improving with AI vs. without AI assistance. The study described focuses on standalone device performance compared to a predicate device.

6. Standalone Performance

Yes, a standalone performance study was done. The reported sensitivity and specificity of 92.5% for the CarieScan PRO are standalone performance metrics, indicating the algorithm's performance without human-in-the-loop assistance.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. Sample Size for the Training Set

The document does not provide information about the sample size used for the training set.

9. How the Ground Truth for the Training Set Was Established

The document does not describe how the ground truth for the training set was established.

Summary

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K090598

CarieScan PRO 510(k) Submission

25 February 2009

5 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter Details 5.1

CarieScan Ltd Prospect Business Centre The Technology Park Dundee DD2 1SW വി Tel: +44 (0) 1382 598 616 Fax: +44 (0) 1382 568 403 www.cariescan.com

EC 1 5 2009

5.2 Official Contact

Nikola Skelly, Quality & Regulatory Manager Tel: +44 (0) 1382 598 616 Fax: +44 (0) 1382 568 403 Email: Nikola.skelly@cariescan.com

Submission date: February 25th 2009

5.3 Device Details

Proprietary / Trade Name:	CarieScan PRO
Classification Name:	Laser Fluorescence Caries Detection Device
Product Codes:	NBL
Common / Usual Name:	Dental Caries Detection Device.

5.4 Equivalent legally marketed devices

Performance	- DIAGNOdent® 2095	K983658.
Safety	- Apex NRG XFR, Electronic Apex Locator	K071133.

5.5 Indications for Use (Intended Use)

For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

5.6 Device Description

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CarieScan PRO 510(k) Submission

Comparison of Technological Characteristics 5.7

5.7.1 Performance

. . .

With respect to performance, the CarieScan PRO is substantially equivalent to the predicate device, DIAGNOdent 2095. The devices are used in the same way for the same purpose, however the technology used is different. The DIAGNOdent uses laser fluorescence, while the CarieScan PRO uses AC impedance spectroscopy.

5.7.2 Safety

A second predicate device has been selected for safety comparison, this is the Apex NRG - Electronic Apex Locator which also uses an impedance technique.

	Candidate Device	Predicate Devices
DeviceCharacteristics		Performance	Safety
	CarieScan PRO	DIAGNOdent	Apex NRG
Intended Use /Indications forUse	For use by dentalprofessionals as an aid inthe diagnosis andmonitoring of dentalcaries.	For use as an aid inthe diagnosis of dentalcaries.	To measure the length ofthe root canal for thepurpose of performingroot canals and relateddental procedures for useby a trained professionalin general dentistry.
Target population	Dental Professionals	SAME	SAME
Anatomical Sites	Teeth	SAME	SAME
Where Used	Dental Surgery	SAME	SAME
Energy usedand/or delivered	Electrical Impedance	Laser Fluorescence	Electrical Impedance
Power Source	Lithium PolymerRechargeable Battery	5- AA Alkaline Battery	1- AA Battery
MeasurementMethod	Comparison ofimpedance at multifrequencies	Light fluorescence	Comparison of impedanceat multi frequencies
Frequencies usedfor comparison	3kHz - 20kHz	N/A	6.5kHz - 1.3 kHz
Performance*	92.5 % sensitivity92.5% specificity	80% sensitivity52% specificity	N/A
Max AppliedCurrent	< 10 μ A	N/A	< 30 μ A

Predicate Comparison Table

See Section 12.2, Substantial Equivalence Discussion.

The CarieScan PRO meets all of the medical safety standards that are applicable, tests have been mo ourced and certificates have been achieved to demonstrate conformity. This is further detailed in Declarations of Conformity (Section 9) and Electrical Safety (Section 17).

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized human figure or bird.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Nikola Skelly Quality & Regulatory Affairs Manager CarieScan Limited Prospect Business Centre, Gemini Crescent The Technology Park Dundee UNITED KINGDOM DD2 1SW

DEC 1 5 2009

Re: K090598

Trade/Device Name: CarieScan PRO Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: November 6, 2009 Received: November 12, 2009

Dear Ms. Skelly:

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.

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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Page 2- Ms. Skelly

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 (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. .

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and

Radiological Health

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K09a598

CarieScan PRO 510(k) Submission

25 February 2009

INDICATIONS FOR USE 4

510(k) Number (if known):

Device Name:

CarieScan PRO

Indications For Use:

For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

A.S. Betz DDS for Dr. K.P. Mulry (Acting)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K0902598

CarieScan Ltd

page 6 of 81

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.