The RAYSCAN α- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Device Description

Modified RAYSCAN α- Expert is designed for panoramic scanning of teeth, jaw and oral cavity, used to create and control the X-ray beam. And as a dental digital panoramic X-ray system with X-ray located on outer part of the oral cavity, includes the Cephalometric scanning function, as an option, for acquiring images of the head. The modifications are as following: Hardware: Added option CEPH sensor (Scan type). In addition to the one-shot type CEPH sensor of original device (K122918), the modified device offers an additional Scan type CEPH sensor. Updated Software including: Additional protocol for new CEPH sensor (Scan type): Lateral wide Additional PANO protocols: Segmentation (Individual Tooth), Bitewing, and Orthogonal RAYSCAN α- Expert offers digital imaging with or without the optional One-shot type & Scan type cephalometric attachment. Detector Options: Base: RAYSCAN α-P: PANO Option: RAYSCAN α-OC: PANO+One-shot CEPH Option: RAYSCAN α-SC: PANO+SCAN CEPH The system includes processing, and archiving "SMARTDent "software(Optional)

AI/ML Overview

The provided text describes a 510(k) submission for the RAYSCAN α-Expert, primarily focusing on modifications to an existing device (K122918). The modifications include adding a "Scan type CEPH sensor" and new PANO protocols. The submission argues for substantial equivalence to the predicate device.

Here's an analysis of the acceptance criteria and study information provided:

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

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy thresholds). Instead, the performance specification comparison table largely establishes that the modified device either has the same specifications as the predicate device or additional specifications for the new "Scan type" cephalometric function. The implicit acceptance criterion is that the new components perform either equivalently to the existing components or to a satisfactory level for their intended function.

Parameter	Acceptance Criteria (Implicit from Predicate & New Features)	Reported Device Performance (Modified K131693)
Common Name	Same as Predicate: Dental panoramic and cephalometric X-ray system	Dental panoramic and cephalometric X-ray system
Indications for use	Same as Predicate: For dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.	The RAYSCAN α- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Performance Specification	Panoramic, One-shot type Cephalometric (optional), Additional Scan type Cephalometric (optional)	PanoramicCephalometric(optional)- One_shot type- Scan type
Detector type	α-OC: PANO+One-shot CEPH (option), α -P : PANO, Additional α -SC: PANO+SCAN CEPH (option)	α-OC: PANO+One-shot CEPH (option)α -P : PANOα -SC: PANO+SCAN CEPH (option)
Detector Type (detail)	Pano: Flat panel X-ray sensor, Ceph(Optional): Flat panel X-ray sensor [One-shot type], Additional CdTe Direct flat panel sensor[Scan type]	Pano: Flat panel X-ray sensorCeph(Optional)- Flat panel X-ray sensor [One-shot type]- CdTe Direct flat panel sensor[Scan type]
Focal size	Same as Predicate: 0.5mm	0.5mm
X-ray Voltage	Same as Predicate: 60~90kVp	60~90kVp
X-ray Current	Same as Predicate: 4~17mA	4~17mA
Total Filtration	Same as Predicate: 2.6 mm Al equivalent	2.6 mm Al equivalent
Magnification	Pano: 1.31, Ceph[One-shot type]: 1.13, Additional Ceph[Scan type]: 1.11	Pano: 1.31Ceph[One-shot type]: 1.13Ceph[Scan type]: 1.11
Scan time	Pano: 14sec, Ceph[One-shot type]: 0.3sec~3.0sec, Additional Ceph[Scan type]: below 18sec	Pano: 14secCeph[One-shot type]: 0.3sec~3.0secCeph[Scan type]: below 18sec
Applicable Standards	Compliance with IEC 60601-1, -1-1, -1-3, -2-7, -2-28, -2-32, -1-2	All listed IEC standards met.
Software Functionality	Modified device performs as intended with no adverse impact from hardware/software changes.	"Software verification testing and validation testing was performed to confirm that the modified device performed as intended and that changes made to the hardware and software had no adverse impact on the functionality of the system. All tests met requirements demonstrating that the modified device performed as expected."
Non-clinical/Clinical Safety	Equivalence to predicate regarding safety and effectiveness, especially for new Scan type CEPH sensor.	Safety & effectiveness reports for the added Scan type cephalometric sensor provided separately. "Non-clinical & Clinical considerations according to FDA Guidance 'Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices' were performed. All test results were satisfactory." "expert review of image comparisons for both devices" concluded substantial equivalence.

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

The document does not provide details on the sample size for any clinical or non-clinical test sets, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature of data). It mentions "safety & effectiveness reports for the added Scan type cephalometric sensor is provided separately" and "report regarding non-clinical & clinical consideration for the added Scan CEPH sensor is provided separately," suggesting such details would be found within those separate documents.

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 mentions an "expert review of image comparisons for both devices" as part of the basis for concluding substantial equivalence. However, it does not specify:

The number of experts.
The qualifications of those experts (e.g., specific medical specialty, years of experience, board certifications).
How "ground truth" was established, only that images were compared.

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

The document does not describe any adjudication method (e.g., 2+1, 3+1) used for establishing ground truth or resolving discrepancies among experts. It only mentions an "expert review of image comparisons."

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor is there any mention of comparing human readers with AI assistance versus without AI assistance. The device in question is an X-ray system, not primarily an AI-driven interpretation tool. The software updates are for new protocols and sensor types, not for diagnostic assistance features requiring such a study.

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

This submission is for an X-ray imaging system, not an algorithm meant for standalone diagnostic performance. Therefore, a standalone algorithm-only performance study is not applicable and not mentioned. The "performance" refers to the imaging system's ability to produce images according to specifications.

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

The document only states that an "expert review of image comparisons" was conducted. It does not explicitly define how ground truth was established beyond this expert review (e.g., whether it involved expert consensus, comparison to a gold standard like pathology, or outcomes data). For an imaging device, "ground truth" often refers to the image quality parameters and features being correctly discernible and meeting technical specifications.

8. The sample size for the training set

The document does not provide any information regarding a training set sample size. This is consistent with the nature of the submission, which focuses on device modifications and substantial equivalence to a predicate, rather than a novel AI algorithm requiring separate training and test sets. Software verification and validation are mentioned, but not in the context of machine learning training.

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

Since no training set is mentioned in the context of machine learning or AI, there is no information on how its ground truth would have been established. The "ground truth" in this context pertains to the functional and safety performance of the hardware and software components based on engineering tests and expert image review.

Summary

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NOV 0 1 2013

K131693
Page 1 of 5

510(k) Submission- RAYSCAN a-Expert

Special 510(k) Summary

The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.

Date:

APPLICANT	RAY Co.,Ltd
ADDRESS	#362-43 (218 Maeyoung St.) 3rd & 4th Floor,Wonchun-dong, Youngtong-gu, Suwon-si, Gyeonggi-do, Korea
Manufacturer	RAY Co.,Ltd#362-43 (218 Maeyoung St.) 3rd & 4th Floor,Wonchun-dong, Youngtong-gu, Suwon-si, Gyeonggi-do, KoreaTEL : +82-31-605-1000FAX : +82-2-6280-5534
Contact Person	Yun-Jung. HA/Managere-mail : yunjung.ha@raymedical.co.kr

Device Name

Trade/Proprietary Name : RAYSCAN α – Expert Common Name: Dental panoramic and cephalometric X-ray system

Classification

Extraoral source dental X-ray system (21 CFR 872.1800) Class : II Product code : MUH Panel : Radiology

Predicate device

RAYSCAN a-Expert (K122918)

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Description

The modifications are as following:

Hardware: Added option CEPH sensor (Scan type). In addition to the one-shot type CEPH sensor of original device (K122918), the modified device offers an additional Scan type CEPH sensor.
· Updated Software including:
Additional protocol for new CEPH sensor (Scan type): Lateral wide
Additional PANO protocols: Segmentation (Individual Tooth), Bitewing, and Orthogonal

RAYSCAN α- Expert offers digital imaging with or without the optional One-shot type & Scan type cephalometric attachment.

Detector Options:

Base: RAYSCAN α-P: PANO Option: RAYSCAN α-OC: PANO+One-shot CEPH Option: RAYSCAN α-SC: PANO+SCAN CEPH

The system includes processing, and archiving "SMARTDent "software(Optional)

Indication for use

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ﺎ ﺳ

Parameter	RAYSCAN α-Expert[Modified]	RAYSCANα-Expert[K122918]	Remarks
Common Name	Dental panoramic andcephalometric X-ray system	Dental panoramic andcephalometric X-ray system	Same
Indicationsfor use	The RAYSCAN α- Expert DentalX-Ray System is an extraoralsource dental panoramic andoptional cephalometric X-raysystem intended to produceX-rays for dental radiographicexamination and diagnosis ofdiseases of the teeth, jaw,and oral structures.	The RAYSCAN α- Expert DentalX-Ray System is an extraoralsource dental panoramic andoptional cephalometric X-raysystem intended to produceX-rays for dental radiographicexamination and diagnosis ofdiseases of the teeth, jaw, andoral structures.	Same
PerformanceSpecification	PanoramicCephalometric(optional)- One_shot type- Scan type	PanoramicCephalometric(optional)-One_shot type	AdditionalScan typeCephalometric(Optional)
Detector type	α-OC: PANO+One-shot CEPH(option)α -P : PANOα -SC: PANO+SCAN CEPH(option)	α-OC:PANO+One-shotCEPH(option)α -P: PANO	AdditionalScan typeCephalometric(Optional)
DetectorType	Pano: Flat panel X-ray sensorCeph(Optional)- Flat panel X-ray sensor[One-shot type]- CdTe Direct flat panelsensor[Scan type]	Pano: Flat panel X-ray sensorCeph(Optional)- Flat panel X-ray sensor	AdditionalScan typeCephalometric(Optional)
Focal size	0.5mm	0.5mm	Same
X-ray Voltage	60~90kVp	60~90kVp	Same
X-ray Current	4~17mA	4~17mA	Same
Total Filtration	2.6 mm Al equivalent	2.6 mm Al equivalent	Same
Magnification	Pano : 1.31Ceph[One-shot type] : 1.13	Pano : 1.31Ceph[One-shot type] : 1.13	Same
	Ceph[Scan type] : 1.11		Additionalspecificationof Scan typeCephalometric(Optional)
Scan time	Pano : 14sec	Pano : 14sec	Same
	Ceph[One-shot type] :	Ceph	Same
	0.3sec~3.0sec	: 0.3sec~3.0sec
	Ceph[Scan type] : below 18sec		Additionalspecificationof Scan typeCephalometric(Optional)
ApplicableStandards	IEC 60601-1	IEC 60601-1	Same
	IEC 60601-1-1	IEC 60601-1-1
	IEC 60601-1-3	IEC 60601-1-3
	IEC 60601-2-7	IEC 60601-2-7
	IEC 60601-2-28	IEC 60601-2-28
	IEC 60601-2-32	IEC 60601-2-32
	IEC 60601-1-2	IEC 60601-1-2
CertificateProduct	CE0120(MDD93/42/EEC)	CE0120(MDD93/42/EEC)	Same

Statement of Substantial Equivalence

3 / 5

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510(k) Submission- RAYSCAN a-Expert

Safety details, for instance the non-clinical performance, in regards to intended use, safety characteristics, PANORAMA sensor (Detector) and One-shot CEPH sensor(Detector) are equivalent. The only difference is the additional option of Scan type CEPH sensor. The safety & effectiveness reports for the added Scan type cephalometric sensor is provided separately.

Remaining sensors are the same, the non-clinical considerations thereof are also equivalent, and the report regarding non-clinical & clinical consideration for the added Scan CEPH sensor is provided separately.

It shares the same technological characteristics as the predicate devices. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device.

Based on the non-clinical and clinical consideration and the outcome of an expert review of image comparisons for both devices, new RAYSCAN α-Expert is substantially equivalent, in terms of safety and effectiveness, with RAYSCAN α- Expert[K122918].

4 / 5

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510(k) Submission- RAYSCAN a-Ex

K131693
Page 5 of 5

Safety and Effectiveness Information

Software verification testing and validation testing was performed to confirm that the modified device performed as intended and that changes made to the hardware and software had no adverse impact on the functionality of the system.

All tests met requirements demonstrating that the modified device performed as expected.

Electrical, mechanical, environmental safety and performance testing according to standards IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with the standard IEC 60601-1-2.

Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed.

All test results were satisfactory.

Conclusions

Based on a comparison of intended use, indications, construction materials, principal of Operation, features and technical data, the RAYSCAN &-Expert system are safe and effective to perform its intended use as well as substantially equivalent to the predicate device

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized emblem of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem. The text is in all capital letters and is in a sans-serif font.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 1, 2013

Ray Co., Ltd. % Mr. Andrew Paeng Consultant 4747 Hoen Avenue SANTA ROSA CA 95405

Re: K131693

Trade/Device Name: RAYSCAN a-Expert Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: October 1. 2013 Received: October 11, 2013

Dear Mr. Paeng:

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 (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set

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Page 2 - Mr. Andrew Paeng

forth in the quality systems (QS) 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. 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.goy/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/ResourcesforYou/Industrv/default.htm.

Sincerely yours.

Mekael D. D'Hara

for

Janine M. Morris 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

K131693 510(k) Number (if known):

Device Name: RAYSCAN α-Expert

Indications For Use:

Prescription Use X AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael D. O'Hara

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiolgical Health Page 1 of 510(k) ======================================================================================================================================================================= K131693

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.