(98 days)
This system is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic use by dentists.
RIOSensor(Model RIS500) is intended to acquire real-time, clinical digital intraoral X-ray images using a solid-state imaging sensor. This system consists of the CMOS sensor and software for image display. This system senses the onset of the X-ray exposure and automatically acquires and save the image data to a PC (software).
Here's a breakdown of the acceptance criteria and study information for the RIO Sensor (RIS 500) based on the provided document:
This device is an intraoral imaging unit (dental X-ray sensor), and the focus of the performance evaluation is on its imaging characteristics, rather than diagnostic AI performance. Therefore, many typical AI-related criteria like MRMC studies, effect size of AI, and ground truth for disease detection are not applicable here. The evaluation centers on the physical and technical performance of the X-ray sensor itself.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Imaging Properties) | Reported Device Performance (RIS500) | Predicate Device-1 (EzSensor P) | Predicate Device-2 (EzSensor) |
|---|---|---|---|
| Theoretical Resolution (lp/mm) | 25 lp/mm | 25 lp/mm | 14.3 lp/mm |
| MTF (Modulation Transfer Function) | > 30% at 6 lp/mm | > 30% at 6 lp/mm | > 30% at 6 lp/mm |
| DQE (Detective Quantum Efficiency) | > 40% at 2.5 lp/mm | > 40% at 2.5 lp/mm | > 40% at 2.5 lp/mm |
| Pixel Size | 20x20 µm | 20x20 µm | 35x35 µm |
| Pixel Matrix (Size 1) | 1000x1500 pixel | 1200x1650 pixel (for Size 1.5) | 572x858 pixel (for Size 1) |
| Pixel Matrix (Size 2) | 1300x1700 pixel | 1300x1800 pixel (for Size 2.0) | 686x944 pixel (for Size 1.5) |
| Sensor Thickness | 5.6 mm | 4.95 mm | 4.95mm |
Note: The predicate devices have slightly different sizing conventions (e.g., "Size 1.5", "Size 2.0") which makes a direct pixel matrix comparison challenging without knowing the exact dimensions corresponding to "Size 1" and "Size 2" for RIS500 relative to the predicates. However, the theoretical resolution, MTF, and DQE are directly comparable and are the primary performance metrics. The RIS500 meets or exceeds the key imaging performance criteria of the predicate devices.
2. Sample Size for the Test Set and Data Provenance
The document primarily describes bench testing and non-clinical testing for evaluating the technical performance of the imaging device. It does not mention a "test set" in the context of clinical images for diagnostic evaluation, as there is no AI algorithm being evaluated for diagnostic efficacy.
- Bench Testing: Used to assess whether parameters related to imaging properties and patient dosage satisfy designated tolerances. The sample size for this is not explicitly stated but implies testing a sufficient number of devices or iterations to demonstrate compliance with standards.
- Non-Clinical Testing: Included MTF and DQE of the detector. No specific "sample size" of images is mentioned beyond the testing methodology itself.
- Clinical Considerations: "For clinical testing, two licensed practitioners/clinicians observed and verified that Intraoral Imaging Unit from RIOSensor (Model name: RIS500)." This suggests a qualitative observation by clinicians, not a quantitative study with a defined image test set.
- Data Provenance: Not applicable in the traditional sense for an AI model. The tests are on the device's hardware performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Ground Truth for Technical Performance: The "ground truth" for the technical performance metrics (MTF, DQE, theoretical resolution) is established by the performance testing standards themselves (e.g., IEC 61223-3-4). These are objective measurements against established physical standards.
- Clinical Observation: Two "licensed practitioners/clinicians" observed and verified the device. Their specific qualifications (e.g., years of experience, specialization) are not detailed beyond being "licensed practitioners/clinicians." This was for general verification, not for establishing diagnostic ground truth on a specific test set of cases.
4. Adjudication Method for the Test Set
Not applicable. There was no diagnostic test set requiring adjudication from multiple experts. The "clinical considerations" involved observation and verification by two practitioners, but not an adjudication process as understood in AI studies for ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size
No, an MRMC comparative effectiveness study was not done. The device is a direct X-ray sensor, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is the X-ray sensor itself; it's not a standalone AI algorithm. Its performance is its ability to acquire and convert X-ray photons into electronic impulses for display.
7. The Type of Ground Truth Used
For the technical performance of the device (MTF, DQE, resolution), the ground truth is established by objective physical measurements against industry standards (e.g., IEC 61223-3-4). This is a form of scientific/engineering ground truth.
8. The Sample Size for the Training Set
Not applicable. This is an X-ray sensor, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no AI model or training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2015
Ray Co., Ltd. % Mr. Andrew H. Paeng Consultant 4747 Hoen Avenue SANTA ROSA CA 95405
Re: K143000
Trade/Device Name: RIO Sensor (RIS 500) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 28, 2014 Received: October 30, 2014
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 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,
Robert A. Ochs
Robert Ochs, Ph.D. Acting 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) K143000
Device Name
Trade Name: RIOSensor Proprietary Name: RIS500 Common Name: Intraoral Imaging Unit
Indications for Use (Describe)
This system is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic use by dentists.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(K) Summary
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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:
| 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, KoreaTEL : +82-31-605-1000FAX : +82-2-6280-5534 |
| Contact Person | Kyungha Seoe-mail: Kyungha.seo@raymedical.co.kr |
Device Name
Trade Name: RIOSensor Proprietary Name: RIS500 Common Name: Intraoral Imaging Unit
Classification
Classification name: solid state x-ray imager (flat panel/digital imager) Regulatory Number: 21 CFR 892.1680 Class: II Product code: MQB Panel: Radiology
Description
RIOSensor(Model RIS500) is intended to acquire real-time, clinical digital intraoral X-ray images using a solid-state imaging sensor. This system consists of the CMOS sensor and software for image display. This system senses the onset of the X-ray exposure and automatically acquires and save the image data to a PC (software).
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Indication for use
This system is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic use by dentists.
"CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals.
Predicate device
-
- Predicate device-1 Manufacturer: HUMANRAY Co., Ltd. Device: EzSensor T 510(k) Number: K121132
-
- Predicate device-2 Manufacturer: E-WOO TECHNOLOGY Device: EzSensor 510(k) Number: K090526
Statement of Substantial Equivalence
| Parameter | Proposed Device | Predicated Device | Predicated Device |
|---|---|---|---|
| Manufacturer | RAY Co., Ltd | HUMANRAY Co., Ltd | E-WOO Technology Co., Ltd. |
| DeviceName | RIS500 | EzSensor P | EzSensor |
| 510(K)Number | K143000Traditional 510k | K121132Special 510k | K090526Traditional 510k |
| Feature | Image: Proposed Device Feature | Image: Predicated Device Feature | Image: Predicated Device Feature |
| Indicationsfor use | This system is intended to collectdental x-ray photons and convertthem into electronic impulses thatmay be stored, views andmanipulated for diagnostic use bydentists. | EzSensor P, Intra-oral ImagingSystem, isintended to collectdental x-ray photons and convertthem into electronic impulses thatmay be stored, viewed, andmanipulated for diagnostic use bydentists. | Indicated for intended to collectdental x-ray photons and convertthem into electronic impulses thatmay be stored, viewed, andmanipulated for diagnostic use bydentist. |
| DeviceDescription | RIOSensor(Model RIS500) isintended to acquire real-time,clinical digital intraoral X-rayimages using a solid-state imagingsensor. This system consists of theCMOS sensor and software forimage display. This system sensesthe onset of the X-ray exposureand automatically acquires andsave the image data to a PC(software). | EzSensor P is a solid state x-rayimager designed for dentalradiographic applications, TheEzSensot P digital intraoral sensorprovides digital image capture toreplace radiographic film/screensystem in general dental diagnosticprocedures. The captured digitalimage is transferred to PersonalComputer via USB interface port. | The EzSensor is a solid state x-ray imager designed for dentalradiographic applications, TheEzSensor provides digital imagecapture for conventionalfilm/screen radiographic dentalexaminations. The device is usedto replace radiographic film/screensystem in general dental diagnosticprocedures. The captured digitalimage is transferred to PersonalComputer via USB interface port |
| SensorDimension | Size 1: 39x25 mmSize 2: 42x30 mm | Size "1.5": 38.7x29.2 mmSize "2.0": 42.8x31.5 mm | Size "1.0": 35.7x25.2 mmSize "1.5": 38.7x29.2 mm |
| SensorThickness | 5.6 mm | 4.95 mm | 4.95mm |
| ActiveArea(mm) | Size 1: 39x25Size 2: 42x30 | Size "1.5": 24.01x33.04Size "2.0": 26.04x36.05 | Size "1.0": 20.02x30.03Size "1.5": 24.08x31.85 |
| USBModule | Integrated USB 2.0 module | Integrated USB 2.0 module | Integrated USB 2.0 module |
| Pixelsize | 20x20 μm | 20x20 μm | 35x35 μm |
| PixelMatrix | Size 1: 1000x1500 pixelSize 2: 1300x1700 pixel | Size "1.5": 1200x1650 pixelSize "2.0": 1300x1800 pixel | Size "1.0": 572x858 pixelSize "1.5": 686x944 pixel |
| PixelPitch | 20x20 μm | 20x20 μm | 35x35 μm |
| TheoreticalResolution | 25 lp/mm | 25 lp/mm | 14.3 lp/mm |
| MTF | More than 30% at 6 lp/mm | More than 30% at 6 lp/mm | More than 30% at 6 lp/mm |
| DQE | More than 40% at 2.5 lp/mm | More than 40% at 2.5 lp/mm | More than 40% at 2.5 lp/mm |
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The intended use, constructions, construction materials, technical characteristics and safety characteristics between RIS500 and Its predicate device are same. Ray Co.,Ltd Page
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Accordingly we can claim the substantially equivalence of RIS500 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 RIS500 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.
Bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - Bench"
Bench testing is used to assess whether or not the parameter measured for describing functionalities related to imaging properties of the dental X-ray device and patient dosage satisfies the designated tolerance.
Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4.
All test results were satisfactory.
Non-clinical considerations were conducted in accordance with FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices". 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 30% at 6 lp/mm and The DQE of detector shows the resolution more than 40% at 2.5 lp/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 RIS500 detector is equal or better than that of predicate device and there is no significant difference in efficiency and safety.
Clinical considerations were conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 20".
For clinical testing. two licensed practitioners/clinicians observed and verified that Intraoral Imaging Unit from RIOSensor(Model name: RIS500).
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 RIS500 is safe and effective to perform its intended use as well as substantially equivalent to the predicate device.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.