(24 days)
This system is a digital intraoral dental radiographic imaging system intended for use by dentists and dental sub-specialists. The system captures, displays and sores diagnostic intraoral radiographic images.
RIOScan(Model RPS500) is Computed radiography system for dental intraoral applications. Imaging plates (i.e, storage phorsphor plates) are exposed in the same way as traditional x-ray film. The x-ray images on these plates are then fed into a small computed radiography system and scanned using a laser. The scanned image data form the plates is digitized and the images are displayed on a monitor and saved to computer. RPS500 is capable of scanning the X-ray exposed imaging plates at various speed, sizes and resolutions. Once an imaging is scanned, the image data is automatically erased form the plate and the plate ejected reuse. RIOScan digital scanner doesn't have a wireless option for data transmission
The provided document is a 510(k) Premarket Notification for a dental intraoral radiographic imaging system (RIOScan, Model RPS500). It focuses on establishing substantial equivalence to previously marketed predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria for a novel AI/medical imaging algorithm.
Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment for an AI performance study is not available in this document. This submission primarily relies on non-clinical performance data and comparisons of technical specifications to predicate devices.
Here's an attempt to answer the questions based on the available information, noting when information is absent:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in the context of an AI algorithm's performance on a test set (e.g., sensitivity, specificity thresholds). Instead, for this imaging device, the performance is demonstrated through technical specifications and comparisons to predicate devices.
| Acceptance Criteria (Implied / Comparison Point) | Reported Device Performance (RIOScan/RPS500) | Predicate Device 1 (DIGORA Optime) Performance | Predicate Device 2 (FireCR Dental) Performance |
|---|---|---|---|
| MTF (Modulation Transfer Function) @ 3 lp/mm | More than 35% | 32% | 34% |
| DQE (Detective Quantum Efficiency) @ 3 lp/mm | More than 10% | 10% @ 2.4 lp/mm | 10% @ 2.6 lp/mm |
| Resolution (Theoretical) | HS: 9 lp/mm, 16 lp/mm; HR: 21 lp/mm, SHR: (Missing Value) | 16.7 lp/mm | HS: 7.8 lp/mm; HR: 14.3 lp/mm |
| Pixel size (selectable) | 24 um (High speed), 32 um (Super resolution), 56 um (Super High resolution) | 30 um (Super resolution), 60 µm (High resolution) | 35 um (Super resolution), 64 um (High resolution) |
| Image data bit depth | 14 bit | 14 bit | 16 bit |
Note: The document explicitly states: "Base on the Non-Clinical Test report, Even though the pixel size and active area of predicate detectors are different, the diagnostic image quality of RPS500 detector is equal or better than that of predicate device and there is no significant difference in efficiency and safety." This serves as the overarching "acceptance."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: This information is not provided as the submission relies on non-clinical (engineering/bench) testing rather than a clinical human-subject study or an image-based test set for an AI algorithm.
- Data Provenance: Not applicable, as the evaluation is based on technical specifications and non-clinical tests.
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)
- This information is not provided and is not applicable to this type of submission, which focuses on device specifications and non-clinical performance, not diagnostic accuracy requiring expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No multi-reader adjudication method was used as there was no clinical image test set or AI algorithm evaluation requiring human interpretation.
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
- No, an MRMC comparative effectiveness study was not done. The document states: "In the case of the RioScan system, clinical images are not necessary to establish substantial equivalence, and the non-clinical performance data alone show that the device works as intended." There is no AI component discussed in this submission that would assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This submission is for a medical imaging device (scanner), not an AI algorithm. The performance evaluation is based on the scanner's physical and technical capabilities (e.g., MTF, DQE) rather than an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of diagnostic accuracy. For the technical performance aspects, the "ground truth" would be established by industry standards for measuring MTF, DQE, resolution, etc., using specific optical benches and phantoms.
8. The sample size for the training set
- Not applicable. This submission is for hardware (a scanner), not a machine learning algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI algorithm, no ground truth was established for it.
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Image /page/0/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 image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15, 2016
RAY Co. Ltd. % Mr. Changhwan Lee Regulatory Affairs Manager 332-7 Samsung 1-ro, Hwaseong-si 445-330 Gyeonggi-do REPUBLIC OF KOREA
Re: K160788
Trade/Device Name: RIOScan (RPS500) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 15, 2016 Received: March 22, 2016
Dear Mr. Lee:
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 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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.'Hara
For
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160788
Device Name Trade Name: RIOScan Proprietary Name: RPS500 Common Name: Computed radiography scanner system
Indications for Use (Describe)
This system is a digital intraoral dental radiographic imaging system intended for use by dentists and dental subspecialists. The system captures, displays and sores diagnostic intraoral radiographic images.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
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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: | February 15, 2016 |
|---|---|
| APPLICANT | RAY Co., Ltd |
| ADDRESS | #332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823, Korea |
| Manufacturer | RAY Co., Ltd332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823, Korea |
| TEL: +82-31-605-1000FAX: +82-2-6280-5534 | |
| Contact Person | Changwhan.Leee-mail: ch0406.lee@raymedical.co.kr |
Device Name
Trade Name: RIOScan Proprietary Name: RPS500 Common Name: Computed radiography scanner system.
Classification
Regulation Name: Extraoral Source X-ray System. Classification name: X-ray, Extraoral, Source, Digital Regulatory Number: 21 CFR 872.1800 Class: II Product code: MUH Panel: Radiology
Description
RIOScan(Model RPS500) is Computed radiography system for dental intraoral applications. Imaging plates (i.e, storage phorsphor plates) are exposed in the same way as traditional x-ray film. The x-ray images on these plates are then fed into a small computed radiography system and scanned using a laser. The scanned image data form the plates is digitized and the images are displayed on a monitor and saved to computer.
RPS500 is capable of scanning the X-ray exposed imaging plates at various speed, sizes and resolutions. Once an imaging is scanned, the image data is automatically erased form the plate and the plate ejected reuse.
Ray Co.,Ltd
Page 1 of 6
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RIOScan digital scanner doesn't have a wireless option for data transmission
Indication for use
This system is a digital intraoral dental radiographic imaging system intended for use by dentists and dental sub-specialists. The system captures, digitizes, displays and sores diagnostic intraoral radiographic images.
Predicate device
-
- Predicate device-1 Manufacturer: PaloDEx Group Oy Device: DIGORA Optime (DXR-60) 510(k) Number: K133231
-
- Predicate device-2 Manufacturer: 3D Imaging & Simulations Corp Device: FireCR Dental Imaging SYstem 510(k) Number: K131442
Statement of Substantial Equivalence
| Parameter | Proposed Device | Predicated Device | Predicated Device |
|---|---|---|---|
| Manufacturer | RAY Co., Ltd | PaloDEx Group Oy | 3D Imaging & Simulations Corp |
| DeviceName | RIOScan | DIGORA® Optime (DXR-60) | FireCR DENTAL IMAGINGSYSTEM |
| 510(K)Number | - | K133231 | K131442 |
| Feature | Image: RIOScan | Image: DIGORA® Optime (DXR-60) | Image: FireCR DENTAL IMAGING SYSTEM |
| Intendeduse | The RIOScan(Model RPS500)is adigital intraoral dental radiographicimaging system intended for use bydentists and dental sub-specialists.The system captures, digitizes,displays and stores diagnosticintraoral radiographic images. | SOREDEX® DIGORA® Optimesystem is intended to be used onlyby dentist and other qualifieddental professional to process x-ray images exposed to the imagingplates from the intraoral complexof the skull | The FireOR Dental imagingsystem is indicated for capturing,digitization and processing of intraoral x-ray images stored inimaging plate recording media |
| Indicationsfor use | The RIOScan scanner system isindicated for capturing, digitizationand processing of intra oral x-rayimages stored in imaging platerecording media. | The DIGORAO® Optime imagingsystem is indicated for capturing,digitization and processing of intraoral x-ray images stored inimaging plate recording media. | The FireCR Dental imagingsystem is indicated for capturing,digitization and processing of intraoral x-ray images stored inimaging plate recording media |
| DeviceDescription | RIOScan(Model RPS500) isComputed radiography systemfor dental intraoral applications.Imaging plates (i.e, storagephorsphor plates) are exposedin the same way as traditionalx-ray film. The x-ray images onthese plates are then fed into asmall computed radiographysystem and scanned using alaser. The scanned image dataform the plates is digitized andthe images are displayed on amonitor and saved to computer.RPS500 is capable of scanningthe X-ray exposed imagingplates at various speed, sizesand resolutions. Once animaging is scanned, the imagedata is automatically erasedform the plate and the plateejected reuse. RIOScan digitalscanner doesn't have a wirelessoption for data transmission | DIGORA® Optime(DXR-60) is adigital radiography system for intraoral imaging plates located indisposable bags. The system maybe used with all x-ray equipmentwhich is designed for intra oralradiography. The image isrecorded on reusable imaging platewhich substitutes for conventionalx-ray film or digital sensor. The x-ray energy absorbed in the imagingplate remains stored as a latentimage. When fed to the device thestored energy is released as anoptical emission proportional tothe stored energy when theimaging plate is stimulated pixelby pixel by a scanning laser. Anoptical system collects theemission for photo electronicsystem, which converts theemission to digital electronicsignals. These signals areprocessed in a computer systemwhich formats and stores thesignals.Further image processing, displayand achieving are carried out withauxiliary software. | The FireCR Dental is ComputedRadiography Reader whichproduces the X-ray diagnosticimage in digital format instead ofusing traditional screens and film.This device utilizes reusable X-raystorage phosphor plate (imagingPlate) that is sensitive to X-ray andstores latent image when it isexposed to X-ray. After X-rayexposure to the X-ray storagephosphor plate, X-ray storagephosphor plate is scanned bymeans of laser in the device. Latentimage in the X-ray storagephosphor plate is released in aform of light by laser scanning.Then the light is collected andconverted into a form of digitalimage. The signal processing ismade to the digital image data suchas the digital filtering, the gain &offset correction and flat fielding.The image can then be viewed on acomputer workstation, adjusted ifnecessary, then stored locally, sentto an archive, printed or sent toPACS system. After acquisition oflatent image from the X-raystorage phosphor plate, it is erasedthoroughly to be reused. |
| AvailableImage plate | Size: 0, 1, 2, 3, 4 | Size: 0, 1, 2, 3 | Size: 0, 1, 2, 3 |
| Image platesize | Size 022 x 35 mmSize 124 x 40 mmSize 231 x 41 mmSize 327 x 54 mm | Size 022 x 31 mmSize 124 x 40 mmSize 231 x 41 mmSize 327 x 54 mm | Size 022 x 31 mmSize 124 x 40 mmSize 231 x 41 mmSize 327 x 54 mm |
| Resolution(Theoretica1) | HS9 lp/mm16 lp/mmHR21 lp/mmSHR | 16.7 lp/mm | HS7.8 lp/mmHR14.3 lp/mm |
| Pixel size(selectable) | 24 um (High speed)32 um (Super resolution)56 um (Super High resolution) | 30 um (Super resolution)60 µm (High resolution) | 35 um (Super resolution)64 um (High resolution) |
| Image databit depth | 14 bit | 14 bit | 16bit |
| Operatingvoltage | 24 VDC (External PSU 100-250Vac, 50/60Hz) | 24 VDC (External PSU 100-250Vac, 50/60Hz) | 24 VDC (External PSU 100-250Vac, 50/60Hz) |
| Lasersafetyclassification | Class 1 laser product EN60825-1:2014(Third Edition) | Class 1 las er product EN60825-1:2007 | Class 1 laser product EN60825-1:2007 |
| Interface | Ethernet RJ-45 10/100 Mbs LAN | Ethernet RJ-45 10/100 Mbs LAN | Ethernet RJ-45 10/100 Mbs LAN |
| MTF | More than 35% at 3 lp/mm | 32% at 3 lp/mm | 34% at 3 lp/mm |
| DQE | More than 10% at 3 lp/mm | 10% at 2.4 lp/mm | 10% at 2.6 lp/mm |
| Erasing | Auto | Auto | Auto |
| Dimensions(W x H xD) | 170 mm x 260 mm x 278 mm | 152 mm x 227 mm x 308 mm | 265 mm x 120 mm x 318 mm |
| Weight | 3.5 kg | 3.5 kg | 4.7 kg |
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The intended use, constructions, construction materials, technical characteristics and safety characteristics between RPS500 and Its predicate device are same.
Accordingly we can claim the substantially equivalence of RPS500 to the predicate device.
Safety and Effectiveness Information:
Electrical, mechanical and environmental safety testing according to standard of IEC 60601-1(2005+ CORR.1(2006)+CORR.2(2007) was performed. EMC testing was conducted in accordance with the standard IEC 60601-1-2(2007).
The software of RPS500 has been validated according to FDA "Guidance for the Content d Premarket Submissions for Software Contained in Medical Devices" and applicable requirements contained in the guidance document.
The software of RPS500 is based on a RIOSenser software(K143000).
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Software release version
| Ver 1.0.0.0 | Ver 1.1.1.0 |
|---|---|
| Initial release for RIOSensor (RIS500) | Initial release for RIOScan (RPS500) |
| K143000 | K160788 |
Compares the characteristics
| Ver 1.0.0.0 | Ver 1.1.1.0 | Remark | |
|---|---|---|---|
| Resolution | 1280 X 800 or higher | 1280 X 800 or higher | |
| Graphic | Video RAM over512MB | Video RAM over512MB | |
| Language | C# | C# | |
| DevelopmentLibrary& Platform | Net Framework 4.0Microsoft DirectX SDK | Net Framework 4.0Microsoft DirectX SDK | |
| ConfigurationIntraoralsensor type | RIO Sensor(RIS 500 -K143000) | RIOSensor(RIS 500 -K143000)RIOScan | Add the device(RIOScan) |
| ImageProcessing | RIOSensor Image Func. | RIOSensor Image Func.RIOScan Image Func. | Add the device(RIOScan) |
| Export | CD/DVD exportUSB export | CD/DVD exportUSB export | |
| Paper print andDICOM print | Paper print andDICOM print | ||
| OS | Window 7,8(32or 64bit) | Window 7,8(32or 64bit) |
Similarities:
In case of the RioView Ver1.0.0.0 for RioSensor(RIS500) and RioView Ver 1.1.1.0 for RioScan(RPS500), similarities exist in the resolution, graphic, OS, method of export and print. Both software version operating principles and operating methods are also similar, power is supplied through the USB interface port for operation and Data is transmitted to a personal PC.
Differences:
There are no difference between RioView Ver 1.0.0.0 for RioSenser(RIS500) and RioView Ver 1.1.1.0 for RioScan(RPS500) as far as purpose of use, operating principles and operating methods are concerned.
The main differences exist in available device, have been added the RioScan(RPS500) to available device in RioView Ver 1.1.1.0.
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Non-clinical considerations were conducted in accordance with FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices".
"In the case of the RioScan system, clinical images are not necessary to establish substantial equivalence, and the non-clinical performance data alone show that the device works as intended. All test results were satisfactory."
The tests include the MTF(Modulation Transfer Function) and DQE(Detective Quantum Efficiency) of detector. MTF of detector shows the resolution more than 92% at 1 1p/mm and The DQE of detector shows the resolution more than 45% at 1 1p/mm.
Base on the Non-Clinical Test report, Even though the pixel size and active area of predicate detectors are different, the diagnostic image quality of RPS500 detector is equal or better than that of predicate device and there is no significant difference in efficiency and safety.
Conclusions
In accordance with the federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. RAY Co., LTD concludes that the RPS500 is safe and effective to perform its intended use as well as substantially equivalent to the predicate device.
§ 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.