The IC-WHCD100 is a toothbrush-sized handpiece used for diagnosis of caries. A USB cable is used to connect the handpiece to a personal computer with a dental imaging software. After a camera cover is placed over the end, the handpiece is positioned over the tooth to be examined. The camera takes images by illuminating the tooth surface with a white LED light for regular tooth image. With fluoresced light, the device can show bacteria on the surface of tooth. With infrared light, the device can show tooth cavity by highlighting enamel. The user can view the images on 510k cleared dental imaging software such as Apteryx vision (K983111), Romexis (K171385), Sidexis (K132773), etc.

AI/ML Overview

The provided text details the FDA 510(k) summary for the IC-WHCD100 (Inspire) device, which is an intraoral camera intended as an aid in the detection and diagnosis of dental caries. However, the document primarily focuses on demonstrating substantial equivalence to predicate devices and provides limited information regarding specific acceptance criteria and detailed study results. Critical information needed to fully answer the request, such as a precise table of acceptance criteria and reported device performance with numerical metrics (e.g., sensitivity, specificity for caries detection), detailed sample size for the test set, number and qualifications of experts for ground truth, adjudication methods, details of comparative effectiveness studies (MRMC), or a comprehensive standalone performance study report are not explicitly present in the provided text.

Based on the available information, here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Performance Test for imaging (Image Sharpness, Image Size, Image Resolution, tooth Caries Detection)" as a non-clinical test. However, it does not provide a specific table of acceptance criteria or the reported device performance metrics (e.g., sensitivity, specificity, accuracy) for caries detection. It only broadly states that "the performance test results of the subject device supports that the transillumination mode works well despite this difference." and "the performance test result supports that the subject device is substantially equivalent to the predicate devices."

Unfortunately, a specific table with numerical acceptance criteria and corresponding performance data for caries detection is not found in the provided text.

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

The document states "performance test results of the subject device supports that the transillumination mode works well despite this difference." and refers to "Performance Tests (Non-clinical)". However, the specific sample size used for the test set (number of teeth, lesions, or patients) and the data provenance (e.g., country of origin of the data, retrospective or prospective nature of data collection) are not disclosed in this 510(k) summary.

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

The provided text does not specify the number of experts used to establish ground truth or their qualifications. It only refers to "Performance Tests" related to caries detection, implying some form of ground truth was used, but details are absent.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for establishing the ground truth for the test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

The provided text does not mention or describe a Multi Reader Multi Case (MRMC) comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The focus is on the device's performance relative to predicate devices, not human-AI collaboration.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The document broadly states "Performance Test for imaging... tooth Caries Detection)". While the device has a caries detection aid capability, the summary does not explicitly detail a standalone algorithm-only performance study with specific metrics (e.g., sensitivity, specificity of the algorithm itself). The device is described as an "aid in the detection and diagnosis," implying human involvement.

7. The Type of Ground Truth Used

The document refers to "tooth Caries Detection" as one of the performance tests. However, the specific type of ground truth used (e.g., expert consensus, pathology/histology, clinical outcomes data, or a combination) is not explicitly stated.

8. The Sample Size for the Training Set

The 510(k) summary does not provide any information regarding a training set sample size. This type of document typically focuses on performance testing for regulatory clearance rather than details of model development. Given that the device is an "intraoral camera with Caries Detection Aid" using specific light sources (405nm and 940nm) to highlight bacteria and cavities, it's possible its "detection aid" might be based on optical properties rather than a complex AI model requiring extensive training data in the traditional sense, but this is speculative given the lack of detail.

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

Since there is no mention of a training set, there is no information on how its ground truth was established.

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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 2, 2020

Good Doctors Co.,Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt. Ste 200 Irvine, California 92620

Re: K183471

Trade/Device Name: IC-WHCD100 (Inspire) Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: Class II Product Code: NBL Dated: June 8, 2020 Received: June 9, 2020

Dear Priscilla Chung:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Srinivas ''Nandu'' Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K183471

Device Name

IC-WHCD100 (Inspire)

Indications for Use (Describe)

The IC-WHCD100 (Inspire) 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

(K183471)

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

Date: July 2, 2020

1. 510K Applicant / Submitter:

Good Doctors Co., Ltd. #208, Woolim Lions Valley B-dong, 283 Bupyeong-daero, Bupyeong-gu, Incheon 403-911, Republic of Korea Tel: +82-32-424-6325 Fax: +82-32-424-6326

2. Submission Contact Person

LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200, Irvine CA 92620 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

Proprietary Name: IC-WHCD100 (Inspire) .
Common Name: Intraoral camera with Caries Detection Aid ●
Classification: Class II (21 CFR 872.1745) .
Product Code: NBL .

4. Predicate Devices

Primary Predicate: VistaCam iX Proof (K150672)
Reference Device: CamX Triton HD Proxi Head (K172007). XRAY VISION (K983111). Planmeca Romexis (K171385), SIDEXIS 4 (K132773), DBSWIN And VistaEasy Imaging Software (K143290)

5. Description:

The IC-WHCD100 is a toothbrush-sized handpiece used for diagnosis of caries. A USB cable is used to connect the handpiece to a personal computer with a dental imaging software.

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After a camera cover is placed over the end, the handpiece is positioned over the tooth to be examined. The camera takes images by illuminating the tooth surface with a white LED light for regular tooth image. With fluoresced light, the device can show bacteria on the surface of tooth. With infrared light, the device can show tooth cavity by highlighting enamel. The user can view the images on 510k cleared dental imaging software such as Apteryx vision (K983111), Romexis (K171385), Sidexis (K132773), etc.

8. Indications for Use

The IC-WHCD100 (Inspire) is intended to be used as an aid in the detection and diagnosis of dental caries.

9. Substantial Equivalence Discussion:

The subject device has the same indications for use as the predicate devices. The power supply and lighting source are also the same.

The predicate device. VistaCam IX Proof, shows fluorescence image using 405nm light source and the reference device, CamX Triton HD Proxi Head, shows transillumination image using 840nm (infrared) light source. The subject device, IC-WHCD100, uses 405nm and 940nm (infrared), and offers both modes(fluorescence & transillumination) that VistaCam IX Proof and CamX Triton HD Proxi Head each offers.

The subject device uses 940nm. whereas, the reference device uses 840mm, however, the performance test results of the subject device supports that the transillumination mode works well despite this difference. The lens type and the resolutions are also different but again the performance test result supports that the subject device is substantially equivalent to the predicate devices.

	Applicant device	Primary device		Reference Device
Company	Good Doctors Co., Ltd.	Durr Dental AG		Durr Dental AG
Product name	IC-WHCD100(inspire)	VistaCam IX Proof		CamX Triton HD ProxiHead
Commonname	Intraoral camera	Intraoral camera		Intraoral camera
ClassificationRegulation	21 CFR 872.1745Laser Fluorescence CariesDetection Device	21 CFR 872.1745Laser FluorescenceCaries Detection Device		21 CFR 872.1745Laser FluorescenceCaries DetectionDevice
Classificationname on FDA	Laser, Fluorescence CariesDetection	Laser, FluorescenceCaries Detection		Laser, FluorescenceCaries Detection
510(k)Number	K183471	K150672		K172007
Similarities
Indication for	This device is an intraoral camera	The VistaCam iX		The CamX Triton HD

use	used to take images of the inside of the mouth or oral cavity.	"Proof" is intended to be used as an aid in the detection and diagnosis of dental caries.	Proxi Head is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions
Technology	Transillumination and fluorescence technology to aid in the detection of carious lesions	Fluorescence technology to aid in the detection of carious lesions	Transillumination to aid in the detection of carious lesions
Detection wave length	940nm, 405nm	405 nm	840 nm
Power supply	USB 5V	USB 5V	USB 5V
Lighting source	LED	LED	LED
Sensor type	CMOS / 5M	CMOS	CMOS
Resolution	1280 x 720	1280 x 1024	1280 x 1024
Cable length	Approximately 3 meters	2.5 meters	2.5 meters
Operating environment	10-40 C20 to 80% RH non-condensing	10-40 C20 to 75% RH non-condensing	10-40 C20 to 75% RH non-condensing
Appearance	Image: dental imaging device	Image: dental imaging device	Image: dental imaging device
Differences
Software	Can be use with other imaging software.	VistaCam iX "Proof" driversoftware and DBSWIN.VistaCam iX "Proof" can only be used with DBSWIN imaging software
Hand piece	Metal (Zinc + plating + UV	ASA+PC (Acrylonitrile	ASA+PC (Acrylonitrile
housing	coating)	StyreneAcrylate +Polycarbonate)	StyreneAcrylate +Polycarbonate)
Spacers	8 mm	8 mm	8 mm
Intensity	3mW/cm squared at 8mm	3 mW/cm squared at8mm	4.1 mW / cm² at adistanceof 7 mm
Lens	Liquid lens	2 Duerr Dental lenses	2 Duerr Dental lenses
Size / weight	129 x 21.5 x 32mm/61g (without cable)	7.48 x 1.03 x 1.03inches /	7.48 x 1.03 x 1.03inches /

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10. Performance Tests (Non-clinical)

Performance Test for imaging (Image Sharpness, Image Size, Image Resolution, tooth ● Caries Detection)
EMC and Electrical Safety Testing in accordance with IEC 60601-1 & IEC 60601-1-2 ●
Software Validation Test
Biocompatibility Tests (Cytotoxicity, Irritation, and Skin Sensitization) in accordance ● with ISO 10993-5 and ISO 10993-10.
Cleaning and Disinfecting Validation Test by referencing ISO 10993-17, AAMI TIR12, AAMI TIR30, ASTM E2314-03, ISO 15883-1, ISO 15883-5, ISO 10993-12, ISO/TS 17665-2
Optical Radiotin Safety Test in accordance with IEC 62471 .

The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences.

11. Conclusions:

Based on the information provided in this premarket notification, Good Doctors Co., Ltd. concludes that the IC-WHCD100 (Inspire) is substantially equivalent to the predicate device as described herein in.

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.