The CRUXCAN (CRX-1000) is a dental computed radiography system and is intended to produce digital X-Ray images for dental radiography purposes. It consists of a scanner, reusable imaging plates and workstation software. This device scans X-Ray exposed imaging plate and produces X-Ray image in digital form. Then, digital image is transferred to workstation for further processing and routing. The design features a built-in erase function and a color touch-screen LCD panel without physical push buttons for device operation. This device is intended to be operated in a radiological environment by qualified staff. The Imaging Plate is a polyester film made of densely applied particles of inorganic crystals called photostimulable phosphor. It is a flexible X-ray sensor for the CR system which can be used with a conventional medical X-ray imaging system and can be employed as a substitute for the screen/film system. The phosphor layer has a function of recording an X-ray image. This photostimulable phosphor is a special luminescent material which stores X-ray energy and emits light proportional to the stored X-ray energy when stimulation energy such as visible light is irradiated onto it. CRUXCAN TWAIN Driver and Viewer which transmit and display images are substantially equivalent to the predicate device software as well in terms of functions and principle of operations. The User interface is slightly different but the differences in design do not raise questions in device effectiveness.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

The document (K183637) describes the CRUXCAN (CRX-1000), a dental computed radiography system. The acceptance criteria and performance study presented here are primarily focused on demonstrating substantial equivalence to predicate devices rather than proving a specific clinical performance threshold against a predefined ground truth or an improvement over human readers.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparative performance shown against the predicate devices. The "SE Note" column indicates whether the subject device is considered "Equivalent" or if there's "No issue on safety and effectiveness" despite differences. This means the subject device's performance, even if quantitatively different, is considered acceptable because it's either comparable or superior without raising new safety/effectiveness concerns.

Category	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (CRUXCAN)	SE Note
Indications for Use	Capturing, digitization, and processing of intra-oral x-ray images.	Capturing, digitization, and processing of intra-oral x-ray images.	Equivalent
Communication	DICOM (Predicate)	TIFF / Raw Format	No issue on safety and effectiveness
Power Supply	50 – 60 Hz, 100 - 240 V ~	50 – 60 Hz, 100 - 240 V ~	Equivalent
Operating System	Windows NT 4.0/2000/XP (Predicate 1), Windows 7 or 8 (Predicate 2)	Windows 10 or higher	Equivalent
X-ray Absorber	Imaging Plate	Imaging Plate	Equivalent
Cassette Size	Size 0, 1, 2, 3 (specific mm dimensions)	Size 0, 1, 2, 3 (specific mm dimensions)	No issue on safety and effectiveness
Pixel Size	40 um, 64 um (Predicate 1); 30um, 60um (Predicate 2)	25 um, 50 um	No issue on safety and effectiveness (Subject device has smaller pixels, considered better)
Dynamic Range (Acq.)	14 bit (Predicates)	8bit / 16 bit	Equivalent (Subject device offers wider dynamic range with 16-bit)
Resolution	12.5 lp/mm @ 40um (Predicate 1); 16.7 lp/mm@30um (Predicate 2)	14.0lp/mm @ 25um	No issue on safety and effectiveness (Subject device's resolution is comparable/better)
DQE at 10% eff.	2.4 lp/mm (Predicates)	2.8 lp/mm	No issue on safety and effectiveness (Subject device has better DQE)
MTF at 3lp/mm	32% (Predicates)	35%	No issue on safety and effectiveness (Subject device has better MTF)
Max. Resolution	40um (Predicate 1); 30um (Predicate 2)	25um	No issue on safety and effectiveness (Subject device has better max resolution)

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

The document states that "Performance studies were conducted on the device imaging plate according to the FDA guidance 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices'." However, it does not specify the sample size used for performance testing (e.g., number of images, number of patients).

Furthermore, the data provenance (e.g., country of origin, retrospective or prospective) for any images used in the performance evaluation is not mentioned in the provided text.

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

The provided document does not mention the use of experts to establish a ground truth for a test set in the context of clinical performance or diagnostic accuracy. The performance evaluation focuses on technical imaging characteristics (e.g., DQE, MTF, resolution).

4. Adjudication Method for the Test Set

Since there is no mention of a test set requiring expert interpretation or establishing clinical ground truth, there is no adjudication method described.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not necessary for the subject device, in order to demonstrate substantial equivalence." Therefore, there is no information on the effect size of human readers improving with AI vs. without AI assistance as this type of study was not conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is an imaging system (scanner, imaging plate, workstation software) that produces images, rather than an AI algorithm for image analysis. Therefore, the concept of a "standalone" algorithm-only performance as typically applied to AI CAD systems does not directly apply in the context presented. The performance tests ("Performance studies were conducted on the device imaging plate") describe the technical capabilities of the imaging system itself.

7. Type of Ground Truth Used

The ground truth for the performance tests appears to be technical measurements and comparisons of physical imaging characteristics (e.g., lp/mm for resolution, percentage for MTF, lp/mm for DQE) against established engineering standards and the specifications of predicate devices. This is not a clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

The document does not mention a training set as this device is a hardware/software system for image acquisition and processing, not a machine learning algorithm that requires a training set in the typical sense.

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

As no training set is mentioned or applicable in the context of this traditional medical device evaluation for image acquisition, there is no information on how ground truth was established for a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 12, 2019

CRUXELL Corp. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 IRVINE CA 92620

Re: K183637

Trade/Device Name: CRUXCAN (CRX-1000) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: December 10, 2018 Received: December 26, 2018

Dear Ms. 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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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,

Michael D. O'Hara

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K183637

Device Name

CRUXCAN (CRX-1000)

Indications for Use (Describe)

The CRUXCAN (CRX-1000) is indicated for capturing, digitization and processing of intra-oral x-ray images stored in imaging plate recording media.

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

(K183637)

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

Date: Feb 5, 2019

1. 510K Applicant / Submitter:

CRUXELL Corp. A-405, Migun Techno World II, 187 techno 2-ro. Yuseong-gu. Daejeon, 34025 South Korea Tel : +82-42-935-2554 Fax : +82-42-931-2554

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: CRUXCAN (CRX-1000)
Common Name: Dental PSP Scanner ●
Classification: Class II (21 CFR 872.1800) ●
Product Code: MUH .
Regulation Name: Extraoral source x-ray system .

4. Predicate Devices

4.1. Digora Optime (K041050) by Soredex Instrumentariumn Corporation
Common Name: Dental PSP Scanner .
Classification: Class II (21 CFR 872.1800) .
Product Code: MUH
Regulation Name: Extraoral source x-ray system .

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4.2. Digora Optime (K133231) by Instrunmentariuin Dental

. Common Name: Dental PSP Scanner
Classification: Class II (21 CFR 872.1800) .
. Product Code: MUH
Regulation Name: Extraoral source x-ray system .

5. Device Description:

The design features a built-in erase function and a color touch-screen LCD panel without physical push buttons for device operation. This device is intended to be operated in a radiological environment by qualified staff.

The Imaging Plate is a polyester film made of densely applied particles of inorganic crystals called photostimulable phosphor. It is a flexible X-ray sensor for the CR system which can be used with a conventional medical X-ray imaging system and can be employed as a substitute for the screen/film system. The phosphor layer has a function of recording an X-ray image. This photostimulable phosphor is a special luminescent material which stores X-ray energy and emits light proportional to the stored X-ray energy when stimulation energy such as visible light is irradiated onto it.

CRUXCAN TWAIN Driver and Viewer which transmit and display images are substantially equivalent to the predicate device software as well in terms of functions and principle of operations. The User interface is slightly different but the differences in design do not raise questions in device effectiveness.

8. Indications for Use

The CRUXCAN (CRX-1000) is indicated for capturing, digitization and processing of intraoral x-ray images stored in imaging plate recording media.

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9. Substantial Equivalence Discussion:

	Subject Device	Predicate Device	Reference Device	SE Note
510k #	K183637	K041050	K133231
Device Name	CRUXCAN	Digora Optime	Digora Optime
Manufacturer	CRUXELL Co., Ltd.	Soredex InstrumentariumnCorporation	InstrunmentariuinDental
Indications for Use	The CRUXCAN (CRX-1000) is indicated forcapturing, digitizationand processing of intra-oral x-ray images storedin imaging platerecording media.	The Digora Optimeimaging system is indicatedfor capturing, digitizationand processing of intra oralx-ray images stored inimaging plate recordingmedia.	The DIGORA0Optime imagingsystem is indicated forcapturing, digitizationand processing ofintra oral x-ray imagesstored in imagingplate recording media.	Equivalent
Communication	TIFF / Raw Format	DICOM	DICOM	No issue onsafety andeffectiveness
Power Supply	50 – 60 Hz100 - 240 V ~	50 – 60 Hz100 - 240 V ~	50 – 60 Hz100 - 240 V ~	Equivalent
Operating System	Windows 10 or higher	Windows NT 4.0/2000/XP	Windows 7 or 8	Equivalent
X-ray Absorber	Imaging Plate	Imaging Plate	Imaging Plate	Equivalent
Cassette Size	Size 0 : 22 x 31mmSize 1 : 24 x 40mmSize 2 : 31 x 41mmSize 3 : 27 x 54mm	Size 0 : 22 x 31mmSize 1 : 24 x 40mmSize 2 : 31 x 41mmSize 3 : 27 x 54mm	Size 0 : 22 x 31mmSize 1 : 24 x 40mmSize 2 : 31 x 41mmSize 3 : 27 x 54mm	No issue onsafety andeffectiveness
Pixel Size	25 um50 um	40 um64 um	30um60um	No issue onsafety andeffectiveness
Dynamic Range(Acquisition)	8bit /16 bit	14 bit	14 bit	Equivalent
Resolution	14.0lp/mm @ 25um	12.5 lp/mm @ 40um	16.7 lp/mm@30um	No issue onsafety andeffectiveness
Imaging PlatePerformance- DQE- MTF- Max. Resolution	DQE at 10% efficiency:2.8 lp/mmMTF at 3lp/mm : 35%Max resolution : 25um	DQE at 10% eff : 2.4lp/mmMTF at 3lp/mm : 32%Max resolution : 40um	DQE at 10% eff : 2.4lp/mmMTF at 3lp/mm : 32%Max resolution : 30um	No issue onsafety andeffectiveness

The CRUXCAN is substantially equivalent to the predicate device, Digora Optime (K041050) and Digora Optime (K133231) in indications for use, imaging principle, and physical characteristics. The CRUXCAN also has similarities in power supply, operating system, X-ray absorber and imaging plate size.

The differences of the three devices are pixel size, dynamic range, resolution, and image plate performance. As compared in the chart above, the subject device has better or substantially equivalent resolution, DQE, and MTF data. The smaller pixel size of subject device than

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the predicate device offers wider dynamic range with storing image data using more bits.

The imaging plates are similar to the predicate plates and they employ the same technology and principle of operation. Despite the minor differences, the results of the performance testing provided in the submission support that the subject device is substantially equivalent to the predicate device.

10. Performance Tests

. Performance studies were conducted on the device imaging plate according to the FDA guidance "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices".
. The CRUXCAN (CRX-1000) has been tested for Electromagnetic Compatibility and Safety in accordance with the IEC60601 standards. The devices operated within the EMI emission, susceptibility and static discharge levels specified in the IEC 60601 standards.
. Software Validation Test

The test results of the tests performed on the subject device supported that it is substantially equivalent to the predicate device.

Clinical testing was not necessary for the subject device, in order to demonstrate substantial equivalence.

11. Conclusions:

Based on the information provided in this premarket notification, CRUXELL Corp. concludes that the CRUXCAN (CRX-1000) is substantially equivalent to the predicate device as described herein in.

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.