(172 days)
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.
RAYSCAN a- 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. RAYSCAN a- Expert offers digital imaging with or without the optional cephalometric attachment. The system includes processing, and archiving "SMARTDent "software(Optional)
The provided document K122918 describes the RAYSCAN α-Expert Dental X-Ray System. However, it does not explicitly detail acceptance criteria or a specific study proving the device meets those criteria in the way typically found for an AI/CADe device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Orthophos XGPlus DS/Ceph K033073) and compliance with electrical, mechanical, environmental, and EMC safety and performance standards.
The closest information regarding performance acceptance criteria and study is within the "Safety and Effectiveness Information" section, which states: "Non-clinical & Clinical considerations according to FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed. All test results were satisfactory." This is a general statement and does not provide specific performance metrics, sample sizes, or ground truth establishment relevant to an AI/CADe system.
Therefore, many of the requested details for an AI/CADe device cannot be extracted from this document, as the RAYSCAN α-Expert is an X-ray imaging system, not an AI-powered diagnostic tool in the sense of the prompt's implied context (e.g., for detecting specific pathologies). The focus is on the safety and effectiveness of the imaging system itself to produce X-rays for examination and diagnosis by a human, not on automated analysis or improved human reading through AI assistance.
Based on the provided text, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or reported device performance metrics in the way one would expect for an AI/CADe device (e.g., sensitivity, specificity, AUC for a diagnostic task). The performance assessment is qualitative, focusing on compliance with safety and effectiveness standards, and substantial equivalence to a predicate device in terms of technical specifications.
| Acceptance Criteria Category | Specific Criteria (Implicit from document) | Reported Device Performance (Implicit from document) |
|---|---|---|
| Safety | Compliance with 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 60601-1-2 (EMC) | "All test results were satisfactory." |
| Effectiveness | Ability to produce X-rays for dental radiographic examination and diagnosis. Substantial equivalence to predicate device (Orthophos XGPlus DS/Ceph K033073) in intended use, indications, construction materials, principle of operation, features, and technical data. | "the RAYSCAN α-Expert system is safe and effective to perform its intended use as well as substantially equivalent to the Predicate device." |
| Image Quality | Not directly specified with metrics, but implied through substantial equivalence to predicate device's image modality (Digital only) and detector types. | Not specified with metrics. |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. The document primarily discusses non-clinical and clinical considerations for the imaging device itself, not a test set for an AI algorithm's diagnostic performance. There is no mention of a "test set" in the context of diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This concerns an AI/CADe system's diagnostic accuracy, which is not the focus of this document for an X-ray imaging system.
4. Adjudication method for the test set
Not applicable/Not provided.
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
Not applicable/Not provided. The device is an X-ray system, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. The device is not an AI algorithm.
7. The type of ground truth used
Not applicable/Not provided.
8. The sample size for the training set
Not applicable/Not provided. The device is an X-ray system, not an AI algorithm that undergoes training.
9. How the ground truth for the training set was established
Not applicable/Not provided.
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MAR 1 5 2013
K122968
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510(k) Submission- RAYSCAN a - Expert
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date:
| APPLICANT | RAY Co.,Ltd |
|---|---|
| ADDRESS | #362-43 (218 Maeyoung Rd.) 3rd & 4th Floor,Wonchun-dong, Youngtong-gu, Suwon-si, Gyeonggi-do, Korea |
| Manufacturer | RAY Co., Ltd#362-43 (218 Maeyoung Rd.) 3rd & 4th Floor,Wonchun-dong, Youngtong-gu, Suwon-si, Gyeonggi-do, KoreaTEL : +82-31-605-1000FAX : +82-2-6280-5534 |
| Contact Person | Yun-Jung HAe-mail : yunjung.ha@raymedical.co.krTEL : +82-31-605-1000FAX : +82-2-6280-5534 |
Device Name
Trade/Proprietary Name : RAYSCAN a - 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
Orthophos XG 105 DS/Ceph Dental X-ray system(K033073)
Description
RAYSCAN a- 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.
RAYSCAN a- Expert offers digital imaging with or without the optional cephalometric attachment. The system includes processing, and archiving "SMARTDent "software(Optional)
Indication for use
The RAYSCAN a- 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.
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KI22918
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Statement of Substantial Equivalence
| Parameter | RAYSCAN α-ExpertRAY Co.,Ltd | Orthophos XGPlus DS/CephK033073 | |
|---|---|---|---|
| Common name | Dental panoramic andcephalometric X-ray system | Dental panoramic and cephalometric X-ray system | |
| Indication for use | The RAYSCAN α- Expert Dental X-RaySystem is an extraoral source dentalpanoramic and optional cephalometricX-ray system intended to produce X-raysfor dental radiographic examination anddiagnosis of diseases of the teeth, jaw, andoral structures. | The Orthophos XGPlus DS/Ceph Dental X-Ray System is an extraoral source dentalpanoramic and optional cephalometric X-ray system intended to produce X-rays fordental radiographic examinationanddiagnosis of diseases of the teeth, jaw,and oral structures. | |
| Mode ofOperation | Continuous operation withintermittent,stated permissible loading | Continuous operation withintermittent load | |
| PerformanceSpecification | PanoramicCephalometric(optional) | PanoramicCephalometric(optional) | |
| Imaging modality | Digital only | Digital only | |
| Exammode | PANO | NormalPedodonticsTMJSinus | Standard panoramaStandard panorama without ascendingbranchesPediatric programLateralAxialSinusProgram for posterior teeth |
| Ceph | PA, APLateralSMVCarpusReverse Town'sWaters | PAAPCarpus | |
| Optional | TSA(Transversal layers based on wide-beam tomography) | ||
| DetectorType | Pano : Flat panel X-ray sensorCeph : Flat panel X-ray sensor | Pano : CCD X-ray sensorCeph : CCD X-ray sensor | |
| Control Panel | Touch monitor(Panel) | Easy Pad(Touch type) | |
| Main Component | Ceph ApparatusVertical CarriageRotatorX-RAY GeneratorX-ray tubeHigh Frequency GeneratorColumn | Ceph ApparatusVertical CarriageRotatorX-ray GeneratorX-ray tubeHigh Frequency GeneratorColumn | |
| Touch monitor (panel) | Easy Pad (Touch type) | ||
| Detector(Panoramic,Cephalometric) | Detector(Panoramic,Cephalometric) | ||
| Chinrest | Chinrest | ||
| Head rest | Head rest | ||
| Automatic Collimator | Collimator | ||
| Exposure switch | Exposure switch | ||
| Emergency stop switch | Emergency stop switch | ||
| AutomaticCollimator | Yes | Yes | |
| Bite block | Bite block | ||
| Accessories | Chinrest(Patient support of thestand type)Chinrest(TMJ, Sinus and etc:) | Chinrest(Patient support of the stand type) | |
| Head rest | Head rest(included temple support) | ||
| X-ray push button withextensible cable | X-ray push button | ||
| Earload | Earplugs with holders | ||
| Nasal bar | Nose support | ||
| Remote controller(Optional) | Remote controller(Optional) | ||
| Rated power | 110-240 V~, 50 / 60 Hz, 2.3kVA | 100-120 V, 220-240 V, 50/60Hz,2.8kW | |
| Class I with type B applied parts | Class I with type B applied parts | ||
| Class | according to IEC 60601-1 | according to IEC 60601-1 | |
| Focal size | 0.5mm | 0.5mm | |
| X-ray Voltage | 60~90kVp | 60~90kVp | |
| X-ray Current | 4~17mA | 3~16mA | |
| Total Filtration | 2.6 mm Al equivalent | 2.5 mm Al equivalent | |
| Detector Pixel | Pano : 100 μm | Pano : 27 μm | |
| size | Ceph : 150 μm | Ceph : 27 μm | |
| Magnification | Pano : 1.31 | Pano : 1.25 | |
| Ceph : 1.13 | Ceph : 1.25 | ||
| Pano : 14.2sec | |||
| Scan time | Pano : 14sec | Pano(Quickshot) : 9.1sec | |
| Ceph : 0.3sec-3sec | Ceph : 9.14sec | ||
| Ceph(Quickshot) : 4.7sec | |||
| Formatcompatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | |
| PC technicalSpecifications(Requirementsfor PC system) | - OS : Windows 7, 32Bit- CPU : Intel Dual core and over- RAM : 4GB and over- HDD : 500GB and over- Network : Gigabit Ethernet- Display : 32 bit color display- Resolution : 1366x768 and over | - OS : Windows 2000 Workstation ,Windows XP Professional Workstationor Vista- RAM min. 256 MB- HDD: > 4 GB/database- > 50 MB/SIDEXIS installation- Network : 10/100 MBit Ethernet- Resolution : 1024x768 and over | |
| Dimension | Panoramic: 1,118mm x 1,481mm x 2,296mm(WxDxH)Panoramic +Cephalostic (optional): 1,672mmx 1,481mm x 2,296mm(WxDxH) | Panoramic: 1,042mm x 1,371mm x 2,249mm(WxDxH)Panoramic+Cephalostic(optional): 1,955mm x 1,371mm x 2,249mm(WxDxH) | |
| Weight | Panoramic: 147kg(324lb)Panoramic+Cephalostic(optional): 164kg(361lb) | Panoramic: 120kg(264lb)Panoramic+Cephalostic(optional): 141kg(310lb) | |
| Type ofinstallation | Wall or floor mount | Wall or floor mount | |
| Patient position | Standing / Wheelchair | Standing / Wheelchair | |
| ApplicableStandards | IEC 60601-1IEC 60601-1-1IEC 60601-1-3IEC 60601-2-7IEC 60601-2-28IEC 60601-2-32IEC 60601-1-2 | IEC 60601-1IEC 60601-1-1IEC 60601-1-3IEC 60601-2-7IEC 60601-2-28IEC 60601-2-32IEC 60601-1-2 | |
| CertificateProduct | CE0120(MDD93/42/EEC) | CE0086(MDD93/42/EEC), FDA,SFDA |
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K122918
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510(k) Submission - RAYSCAN a - Expert
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K1229.18
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510(k) Submission- RAYSCAN a - Expert
RAYSCAN a- Expert have the same indication for use as the predicate devices, 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 devices.
Safety and Effectiveness Information
Electrical, mechanical, environmental safety and performance testing according to standard 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 standard IEC 60601-1-2. Non-clinical & Clinical considerations according to FDA 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 a- Expert system is safe and effective to perform its intended use as well as substantially equivalent to the Predicate device.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting three abstract shapes, possibly representing people or services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 15, 2013
Ray, Co., Ltd. % Mr. Andrew Paeng Consultant 8920 Wilshire Blvd., Suite 603 BEVERLY HILLS CA 90211
Re: K122918
Trade/Device Name: RAYSCAN α-Expert Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: January 14, 2013 Received: February 06, 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. Iisting 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. 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 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,
Smh7)
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
510(k) Number (if known): K122918
Device Name: RAYSCAN a- Expert
Indications for Use:
The RAYSCAN «- 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K122918 510(k)
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§ 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.