RAYSCAN a-Expert 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate dentomaxillofacial 3D images. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. 2D Image is obtained using the standard narrow beam technique.

Device Description

RAYSCAN α-Expert 3D is a 3D computed tomography for scanning hard tissues such as bones and teeth. By rotating the c-arm that include the high voltage generator all-in-one xray tube and a detector on each end, a CBCT image of whole dentomaxillofacial is attained by recombining data from the same level that are scanned from different angles. Panoramic image scanning function for attaining images of the entire or segmental teeth and cephalometric scanning option (One shot type & Scan type) for attaining the cephalic images are included. It allows to choose from two different types of CEPH detectors: Base: RAYSCAN α-3D: CT+PANO Option: RAYSCAN α-Multi 3D: CT+PANO+One-shot CEPH Option: RAYSCAN a-SM3D: CT+PANO+SCAN CEPH SMARTDent software for processing and archiving is optional.

AI/ML Overview

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

The document (K131695) describes the RAYSCAN α-Expert 3D, a dental panoramic/tomography and cephalometric x-ray system. This is a Special 510(k) submission, indicating a modification to a previously cleared device (K122981).

Emphasis: It's crucial to understand that this document is a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not typically involve detailed performance studies with acceptance criteria in the way one might expect for a novel device or a significantly modified one that requires extensive clinical validation. Instead, the "study" proving acceptance is largely based on demonstrating that the modified device's performance is equivalent to the predicate, particularly for the new feature (Scan type CEPH sensor).

Acceptance Criteria and Study Details:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a Special 510(k) for substantial equivalence to a predicate device, the "acceptance criteria" are essentially for demonstrating that the modified device's specifications and performance meet or are equivalent to the predicate device, especially for the new feature.

Parameter	Acceptance Criteria (Predicate: RAYSCAN α-Expert 3D [K122981])	Reported Device Performance (Modified: RAYSCAN α-Expert 3D)	Device Meets Criteria?
Common Name	Dental panoramic/tomography and cephalometric x-ray system	Dental panoramic/tomography and cephalometric x-ray system	Yes
Indications for Use	Intended for dental radiographic examination of teeth, jaw, oral structures; panoramic examinations, implantology, TMJ studies, cephalometry; capability for dento-maxillo-facial 3D images using CBVT technique; uses cone-shaped x-ray beam projection onto flat panel detector for 3D reconstruction; 2D images via standard narrow beam.	Intended for dental radiographic examination of teeth, jaw, oral structures; panoramic examinations, implantology, TMJ studies, cephalometry; capability for dento-maxillo-facial 3D images using CBVT technique; uses cone-shaped x-ray beam projection onto flat panel detector for 3D reconstruction; 2D images via standard narrow beam.	Yes
3D Technology	CBCT Cone beam Computed Tomography	CBCT Cone beam Computed Tomography	Yes
Performance Specification	Panoramic, Cephalometric (optional: One_shot type)	Panoramic, Cephalometric (optional: One_shot type, Scan type)	Yes (with added Scan type)
Functional Option	Base: α -3D : CT+PANO; Option: a-Multi 3D: CT+PANO+One-shot CEPH	Base: α -3D : CT+PANO; Option: a-Multi 3D: CT+PANO+One-shot CEPH(option), a -SM3D: CT+PANO+SCAN CEPH(option)	Yes (with added Scan type option)
Detector Type (CT)	Flat panel X-ray sensor	Flat panel X-ray sensor	Yes
Detector Type (Pano)	Flat panel X-ray sensor	Flat panel X-ray sensor	Yes
Detector Type (Ceph, One-shot)	Flat panel X-ray sensor	Flat panel X-ray sensor(One-shot type)	Yes
Detector Type (Ceph, Scan type)	Not applicable (predicate did not have this)	CdTe Direct flat panel sensor [Scan type]	N/A (new feature, performance evaluated for equivalence)
Focal Size	0.5mm	0.5mm	Yes
Field of View (CT)	90x90mm	90x90mm	Yes
X-ray Voltage	60-90kVp	60~90kVp	Yes
X-ray Current	4-17mA	4~17mA	Yes
Total Filtration	2.6 mm Al equivalent	2.6 mm Al equivalent	Yes
Magnification (CT)	1.39	1.39	Yes
Magnification (Pano)	1.31	1.31	Yes
Magnification (Ceph One-shot)	1.13	1.13	Yes
Magnification (Ceph Scan type)	Not applicable	1.11	N/A (new feature, performance evaluated for equivalence)
Scan Time (CT)	14sec	14sec	Yes
Scan Time (Pano)	14sec	below 14sec	Yes
Scan Time (Ceph One-shot)	0.3sec~3.0sec	0.3sec~3.0sec	Yes
Scan Time (Ceph Scan type)	Not applicable	below 18sec	N/A (new feature, performance evaluated for equivalence)
Safety and EMC (Applicable Standards)	IEC 60601-1, -1-1, -1-3, -2-7, -2-28, -2-32, -2-44, -1-2	IEC 60601-1, -1-1, -1-3, -2-7, -2-28, -2-32, -2-44, -1-2	Yes
Certificate Product	CE0120(MDD93/42/EEC)	CE0120(MDD93/42/EEC)	Yes
Non-clinical & Clinical Considerations (for added Scan CEPH sensor)	N/A	Report provided for equivalence	Yes

Summary of "Acceptance": The device meets "acceptance criteria" by demonstrating that all parameters common with the predicate device are identical or within acceptable bounds, and the new "Scan type CEPH sensor" feature is evaluated and found to be substantially equivalent in terms of safety and effectiveness.

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

The document does not explicitly state a "test set" sample size or its provenance in terms of patient data. For a Special 510(k), the focus is often on engineering verification and validation (V&V) and comparing the new feature to the existing one.

Test Set: Not explicitly defined in terms of patient images for a statistical study. The "test set" for demonstrating equivalence appears to be qualitative comparisons of imaging performance, particularly for the new "Scan type CEPH sensor."
Data Provenance: Not specified. However, given that the manufacturer is based in South Korea, it's plausible any internal testing or "expert review of image comparisons" would involve data generated internally, possibly from phantoms or a limited set of patient images, likely retrospective if not specifically collected for this submission.

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

The document mentions an "outcome of experts review of image comparisons."

Number of Experts: Not specified.
Qualifications of Experts: Not specified. It's reasonable to infer they would be qualified to review dental radiographic images, such as radiologists or oral and maxillofacial radiologists, but specific experience levels are not provided.

4. Adjudication Method for the Test Set

The document states "outcome of experts review of image comparisons," implying a qualitative assessment.

Adjudication Method: Not explicitly stated (e.g., 2+1, 3+1). It was likely a consensus approach or individual expert assessment contributing to an overall finding of equivalence. There's no detail on how disagreements would be resolved.

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

MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is an imaging system, not an AI-assisted diagnostic tool. The submission is about physical device performance and substantial equivalence, not the improvement of human readers with AI assistance.

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

Standalone Performance: Not applicable in the context of an AI algorithm. This device is an X-ray imaging system. The "performance" assessment focuses on the image quality produced by the system and its technical specifications compared to the predicate device.

7. The Type of Ground Truth Used

Type of Ground Truth: For the "expert review of image comparisons," the "ground truth" would be the subjective assessment of image quality, diagnostic utility, and comparability between images from the modified device (especially the new CEPH scan type) and the predicate device. This is a form of expert consensus/assessment, rather than pathology or outcomes data. For the technical specifications, the ground truth is established through engineering measurements and adherence to international standards.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is an X-ray imaging machine, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

NOV 01 2013

K131695
Page 1 of 5

510(k) Submission- RAYSCAN a-Expe

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, Korea
	TEL : +82-31-605-1000
	FAX : +82-2-6280-5534
Contact Person	Yun-Jung HA / Manager
	e-mail : yunjung.ha@raymedical.co.kr

Device Name

Trade/Proprietary Name : RAYSCAN α~Expert 3D Common Name: Dental panoramic/tomography and cephalometric x-ray system

Classification

x-ray, tomography, computed, dental (21 CFR 892.1750) Class : II Product code : OAS Panel : Radiology

Predicate device

RAYSCAN α-Expert 3D(K122981)

{1}------------------------------------------------

Description

Panoramic image scanning function for attaining images of the entire or segmental teeth and cephalometric scanning option (One shot type & Scan type) for attaining the cephalic images are included. It allows to choose from two different types of CEPH detectors:

Detector Options:

Base: RAYSCAN α-3D: CT+PANO Option: RAYSCAN α-Multi 3D: CT+PANO+One-shot CEPH Option: RAYSCAN a-SM3D: CT+PANO+SCAN CEPH

SMARTDent software for processing and archiving is optional.

Indication for use

The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations.

2D Image is obtained using the standard narrow beam technique.

{2}------------------------------------------------

Parameter	RAYSCAN a-- Expert 3D [Modified]	RAYSCANa-Expert 3D [K122981]
Common	Dental panoramic/tomography and	Dental panoramic/tomography and
Name	cephalometric x-ray system	cephalometric x-ray system
Indications	RAYSCAN &-Expert 3D panoramic x-ray	RAYSCAN α-Expert 3D panoramic x-ray
for use	imaging system with cephalostat, is an	imaging system with cephalostat, is an
	extraoral source x-ray system, which is	extraoral source x-ray system, which is
	intended for dental radiographic examination	intended for dental radiographic examination
	of the teeth, jaw, and oral structures,	of the teeth, jaw, and oral structures,
	specifically for panoramic examinations and	specifically for panoramic examinations and
	implantology and for TMJ studies and	implantology and for TM3 studies and
	cephalometry, and it has the capability, using	cephalometry, and it has the capability, using
	the CBVT technique, to generate dento-	the CBVT technique, to generate dento-
	maxillo-facial 3D images.	maxillo-facial 3D images.
	The device uses cone shaped x-ray beam	The device uses cone shaped x-ray beam
	projected on to a flat panel detector, and	projected on to a flat panel detector, and
	the examined volume image is reconstructed	the examined volume image is reconstructed
	to be viewed in 3D viewing stations.	to be viewed in 3D viewing stations.
	2D Images are obtained using the	2D Images are obtained using the
	standard narrow beam technique.	standard narrow beam technique.
	CBCT Cone beam	CBCT Cone beam
3D technology	Computed Tomography	Computed Tomography
	CBCT Computed tomography	CBCT Computed tomography
	Panoramic	Panoramic
PerformanceSpecification	Cephalometric(optional)	Cephalometric(optional)
	- One_shot type	-One_shot type
	- Scan type
FunctionalOption	Base	Base
	α -3D : CT+PANO	α -3D : CT+PANO
	Option	Option
	a-Multi 3D: CT+PANO+One-shot CEPH(option)	a-Multi 3D: CT+PANO+One-shot CEPH(option)
	a -SM3D: CT+PANO+SCAN CEPH(option)
	Computed Tomography(CT) :	Computed Tomography(CT) :
	Flat panel X-ray sensor	Flat panel X-ray sensor
Delector	Pano : Flat panel X-ray sensor	Pano : Flat panel X-ray sensor
Type	Ceph(Optional)	Ceph(Optional)
	- Flat panel X-ray sensor(One-shot type)	- Flat panel X-ray sensor
	- CdTe Direct flat panel sensor[Scan type]
Focal size	0.5mm	0.5mm
Field ofView(CT)	90x90mm	90x90mm

Statement of Substantial Equivalence

{3}------------------------------------------------

X-ray Voltage	60~90kVp	60-90kVp
X-ray Current	4~17mA	4~17mA
Total Filtration	2.6 mm Al equivalent	2.6 mm Al equivalent
Magnification	CT : 1.39	CT : 1.39
	Pano : 1.31	Pano : 1.31
	Ceph[One-shot type] : 1.13	Ceph[One-shot type] : 1.13
	Ceph[Scan type] : 1.11
Scan time	CT : 14sec	CT : 14sec
	Pano : below 14sec	Pano : 14sec
	Ceph[One-shot type] : 0.3sec~3.0sec	Ceph : 0.3sec~3.0sec
	Ceph[Scan type] : below 18sec
ApplicableStandards	IEC 60601-1	IEC 60601-1
	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 60601-2-44	IEC 60601-2-44
	IEC 60601-1-2	IEC 60601-1-2
CertificateProduct	CE0120(MDD93/42/EEC)	CE0120(MDD93/42/EEC)

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

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 considerations and the outcome of experts review of image comparisons for both devices, new RAYSCAN α-Expert 3D is substantially equivalent, in terms of safety and effectiveness, to the predicate device RAYSCAN α- Expert 3D[K122981].

{4}------------------------------------------------

510(k) Submission- RAYSCAN a-Expert 3D

K131695
Page 5 of 5

Safety and Effectiveness Information

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, IEC 60601-2-32 and IEC 60601-2-44 was performed, and EMC testing was conducted in accordance with the standard IEC 60601-1-2.

In addition, 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, constructions, construction materials, principal of Operations, features and technical data, the RAYSCAN α-Expert 3D system are safe and effective to perform its intended use as well as substantially equivalent to the predicate device

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/12 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.

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: K131695

Trade/Device Name: RAYSCAN a-Expert 3D Regulation Number: 21 CFR 872.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS 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

{6}------------------------------------------------

Page 2 - Mr. Andrew Paeng

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 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/ResourcesforYou/Industrv/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.gov/MedicalDevices/Safety/ReportalProblem/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/Industry/default.htm.

Sincerely yours,

Michael D. O'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

{7}------------------------------------------------

Indications for Use

510(k) Number (if known): K131695

Device Name: RAYSCAN a-Expert 3D

Indications For Use:

2D Image is obtained using the standard narrow beam technique.

Over-The-Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ x AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health K131695 510(k) ==

Page 1 of

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.