(30 days)
Mars1417XF-GSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications.
Mars1417XF-GSI Wireless Digital Flat Panel Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 35.04cm×42.54cm. The sensor plate of Mars1417XF-GSI Wireless Digital Flat Panel Detector is direct-deposited with Gd2O2S scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Mars1417XF-GSI Wireless Digital Flat Panel Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software.
The provided document is a 510(k) summary for a medical device called the "Wireless Digital Flat Panel Detector" (Model: Mars1417XF-GSI). This document primarily focuses on demonstrating substantial equivalence to a predicate device (Mars1417V-PSI, K161730) rather than presenting a detailed study with acceptance criteria for an AI/CAD algorithm.
The device itself is a digital X-ray detector, not an AI or CAD system that provides diagnostic assistance. Therefore, many of the requested criteria such as "effect size of how much human readers improve with AI vs without AI assistance" or "adjudication method" for establishing ground truth for an AI algorithm are not applicable to the information provided.
However, I can extract information related to the technical performance of the device, which can be seen as acceptance criteria for its physical characteristics and image quality, and how it was tested.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a typical clinical study sense for an AI device. Instead, it compares the technical characteristics of the proposed device to its predicate device to demonstrate substantial equivalence. These technical characteristics can be considered as performance metrics that, when similar or improved, demonstrate "acceptance" in the context of a 510(k) submission.
| Characteristic | Predicate Device (Mars1417V-PSI) Performance | Proposed Device (Mars1417XF-GSI) Performance |
|---|---|---|
| Image Matrix Size | 2304 × 2800 pixels | 2336 × 2836 pixels |
| Pixel Pitch | 150μm | Same (150μm) |
| ADC Digitization | 14 bit | 16 bit |
| Effective Imaging Area | 355 mm × 434 mm | 350.4 mm × 425.4 mm |
| Spatial Resolution | Min. 3.4lp/mm | Min. 3.3lp/mm |
| Modulation Transfer Function (MTF) | 0.75 at 0.5lp/mm | 0.84 at 1 lp/mm |
| Detective Quantum Efficiency (DQE) | 0.27 at 0.5 lp/mm (RQA5, 3.2μGy) | 0.43 at 1 lp/mm (RQA5, 2.5μGy) |
| Power Consumption | Max. 13W | Max. 19W |
| Communications | Wired: Gigabit Ethernet, Wireless: IEEE 802.11a/b/g/n | Wireless: IEEE 802.11a/b/g/n |
| Dimensions | 384 mm × 460 mm × 15 mm | Same (384 mm × 460 mm × 15 mm) |
| Operating Temperature | +5 ~ +35°C | +5 ~ +30°C |
| Operating Humidity | 30 ~ 75% (Non-Condensing) | 10 ~ 80% (Non-Condensing) |
| Storage/Transportation Temperature | -20 ~ +55°C | -20 ~ +50°C |
| Storage/Transportation Humidity | 10 ~ 90% (Non-Condensing) | 10 ~ 90% (Non-Condensing) |
Note: The "acceptance criteria" for these are generally that the proposed device performs comparably or better, demonstrating that the changes do not negatively impact safety or effectiveness. For some parameters, like ADC Digitization, the proposed device shows an improvement (16 bit vs 14 bit).
2. Sample size used for the test set and the data provenance:
The document describes non-clinical studies focused on the physical and performance attributes of the detector itself, not on analyzing patient data with an algorithm. Therefore, there isn't a "test set" of patient images in the context of an AI algorithm evaluation.
The non-clinical studies performed include:
- Electrical Safety and EMC testing (IEC/ES 60601-1, IEC 60601-1-2)
- Biological Evaluation (ISO 10993-1)
- Evaluation of detector characteristics: Detective quantum efficiency (DQE), Quantum limited performance, Modulation transfer function (MTF), Effects of aliasing, Sensitivity linearity, Lag, Change in detection sensitivity, Dose requirement and reciprocity changes, Stability of device characteristics with time, Uniformity of device characteristic, Noise power spectrum (NPS), Spatial resolution, Image Acquisition time, and Black level.
The "sample size" for these technical tests would refer to the number of devices or components tested, which is not specified but is typically a small number for device verification. The data provenance would be laboratory testing data, not patient data from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this is not an AI/CAD device being evaluated on clinical images by human experts. The "ground truth" for the technical performance metrics (e.g., DQE, MTF) is established through standardized physical measurements and calculations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as there is no clinical test set requiring expert adjudication.
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. The device is a digital X-ray detector, not an AI or CAD system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device itself is the "standalone" component in the sense that it converts X-rays to digital images without an AI algorithm for diagnostic interpretation. The document explicitly states that the device is a "key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the evaluation of the detector's image quality and physical performance, the "ground truth" is established through physical measurements and calculations using standardized methods (e.g., for DQE, MTF, spatial resolution). These are objective technical metrics, not clinical ground truth like pathology or expert consensus.
8. The sample size for the training set:
Not applicable. This device is an X-ray detector, not a machine learning model that requires a training set. The "software" mentioned (iRay DR and iRay SDK) are for device control, image acquisition, and processing, not for AI-based interpretation.
9. How the ground truth for the training set was established:
Not applicable (see point 8).
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iRay Technology Taicang Ltd. Meng Li Registration and Regulatory Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone TAICANG, JIANGSU 215434 CN
October 17, 2018
Re: K182550
Trade/Device Name: Wireless Digital Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: September 13, 2018 Received: September 17, 2018
Dear Meng Li:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D'Hara For
Robert A. 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
510(k) Number (if known)
K182550
Device Name
Wireless Digital Flat Panel Detector
Indications for Use (Describe)
Mars1417XF-GSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------- |
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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
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[510(k)] Application
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
August 1st, 2018
2. Submitter;s Information [21 CFR 807.92(a)(1)]
| Company Name: | iRay Technology Taicang Ltd. |
|---|---|
| Company Address: | No.33 Xinggang Road, Taicang Port Economic andTechnological Development Zone, Jiangsu, China 215434 |
| Contact Person: | Meng Li |
| Phone: | 0512-53690872 |
| Fax: | 0512-53690872 |
| Email: | meng.li@iraychina.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Wireless Digital Flat Panel Detector |
|---|---|
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Mars1417XF-GSI |
| Classification Name: | Stationary X-Ray System |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification predicates within this submission are as follows: Manufacturer: iRay Technology Co.,Ltd.
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K182550
iRay Technology Taicang Ltd.
| Trade Name: | Wireless Digital Flat Panel Detector |
|---|---|
| Model Name: | Mars1417V-PSI |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| FDA 510 (k) #: | K161730 |
5. Description of the Device [21 CFR 807.92(a)(4)]
Mars1417XF-GSI Wireless Digital Flat Panel Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 35.04cm×42.54cm.
The sensor plate of Mars1417XF-GSI Wireless Digital Flat Panel Detector is directdeposited with Gd2O2S scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface.
The major function of the Mars1417XF-GSI Wireless Digital Flat Panel Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software.
6. Intended Use [21 CFR 807.92(a)(5)]
6.1. Intended Use
Mars1417XF-GSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures. This device is not intended for mammography or dental applications.
[510(k)] Application
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6.2. Suitable patient
It is suitable for providing digital X-ray imaging for DR system conventional photography but not intended for mammography or dental applications. The remaining notes depend on the DR system.
6.3. Processing of input and output
When flat panel detector works continuously, it can automatically distinguish Xray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.
| Item | Predicate Device:Wireless Digital Flat PanelDetector | Proposed Device:Wireless Digital Flat PanelDetector | ||
|---|---|---|---|---|
| 510(K)Number | K161730 | To be assigned | ||
| Intended Use | The Mars1417V-PSIWireless Digital Flat PanelDetector is indicated fordigital imaging solutiondesigned for providinggeneral radiographicsystem in all generalpurpose diagnosticprocedures. | Same | ||
| ClassificationName | Stationary X-ray system | Same | ||
| Product Code | MQB | Same | ||
| RegulationNumber | 21 CFR 892.1680 | Same | ||
| Predicate Device: | Proposed Device: | |||
| Item | Wireless Digital Flat PanelDetector | Wireless Digital Flat PanelDetector | ||
| Panel: | Radiology | Same | ||
| Classification: | II | Same | ||
| X-Ray Absorber(Scintillator): | Gd2O2S | Same | ||
| Installation Type: | Wireless, Portable | Same | ||
| ReadoutMechanism: | Thin Film Transistor | Same | ||
| Image MatrixSize: | 2304 × 2800 pixels | 2336× 2836 pixels | ||
| Pixel Pitch: | 150μm | Same | ||
| ADC Digitization | 14 bit | 16 bit | ||
| EffectiveImaging Area: | 355 mm × 434 mm | 350.4 mm × 425.4 mm | ||
| SpatialResolution: | Min. 3.4lp/mm | Min. 3.3lp/mm | ||
| ModulationTransferFunction(MTF) | 0.75 at 0.5lp/mm | 0.84 at 1 lp/mm | ||
| DetectiveQuantumEfficiency(DQE) | 0.27 at 0.5 lp/mm (RQA5,3.2μGy) | 0.43 at 1 lp/mm (RQA5,2.5μGy) | ||
| PowerConsumption: | Max. 13W | Max. 19W | ||
| Item | Predicate Device:Wireless Digital Flat PanelDetector | Proposed Device:Wireless Digital Flat PanelDetector | ||
| Communications: | Wired: Gigabit Ethernet(1000BASE-T)Wireless: IEEE802.11a/b/g/n (2.4 GHz / 5 GHz) | Wireless: IEEE802.11a/b/g/n (2.4 GHz / 5 GHz) | ||
| Imaging protectPlate: | Carbon Fiber Plate | Same | ||
| Cooling: | Air cooling | Same | ||
| Dimensions: | 384 mm × 460 mm × 15 mm | Same | ||
| Operation: | Temperature: +5 ~ +35°CHumidity: 30 ~ 75%(Non-Condensing)Atmospheric pressure: 70 ~ 106 kPaAltitude: Max. 3000 meters | Temperature: +5 ~ +30°CHumidity: 10 ~ 80%(Non-Condensing)Atmospheric pressure: 70 ~ 106 kPaAltitude: Max. 3000 meters | ||
| Storage andTransportation:(detector) | Temperature: -20 ~ +55°CHumidity: 10 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~ 106 kPaAltitude: Max. 3000 meters | Temperature: -20 ~ +50°CHumidity: 10 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~ 106 kPaAltitude: Max. 3000 meters | ||
| Software | iRay DRThe iRay DR used forgetting Digital X -ray | iRay SDK(includeiDetector) is intend tosupply API interface for | ||
| Item | Predicate Device:Wireless Digital Flat PanelDetector | Proposed Device:Wireless Digital Flat PanelDetector | ||
| radiography images fromthe flat panel detectors.iRay DR is used to handlethe DICOM protocol(DICOM 3.0),iRay DR is responsible forthe DR equipmentmanagement, acquisitionand processing functions,to provide patientregistration, scanning,image processing, imageforwarding, image printingand other functions. | DR system manufacturers.DR system manufacturercontrol the detector bySDK interface. SDK is notintend to use directly byother users beside DRsystem manufacturers. |
7. Technological Characteristic [21 CFR 807.92(a)(6)]
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[510(k)] Application
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[510(k)] Application
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[510(k)] Application
8. System requirements to operate with other radiographic system components
-
- Recommended Generator Specification:
Energy range: 40~150kVp
- Recommended Generator Specification:
mA range: 10~1000mA (depending on the generator power)
ms range: 106300ms to produce 0.11000mAs (depending on the generator power) Note: To our best knowledge, the detector is compatible with the X-ray generators with the specifications described above. If you have any questions regarding the compatibility issue for other generators, please contact your distributor or iRay's service office.
-
- Application Program Interface (API) for system integration manufacturer Peripheral hardware: Mars1417XF-GSI detector connected via wireless communication.
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K182550
[510(k)] Application
iRay Technology Taicang Ltd.
| Operating System: | Windows XP/7 32/64bit |
|---|---|
| CPU: | Intel Core i5 3.6G |
| Memory: | 8G DDR3 |
| Hard Disk: | 640 G |
| LAN Card: | Intel Pro EXP9301CT PRO |
| Gigabit Network Adapter with PCIe interface |
3) X-ray exposure mode
The AED trigger module is a unit can connect X-ray signal in the Mars1417XF-GSI. Once there is X-ray generator exposure exist, the inner trigger module will detect the X-ray radiation and output signal to the detector. Until the exposure finished, the detector will receive a signal which represent the end of exposure from the inner trigger module and begin to acquire the image.
9. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
-
- Electrical Safety and EMC testing:
Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 was performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.
- Electrical Safety and EMC testing:
-
- Biological Evaluation:
The materials of the detector which contact operators' or patient's skin have been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device.
- Biological Evaluation:
-
- Nonclinical Considerations:
The non-clinical studies have been performed and the results have shown that the Mars1417XF-GSI wireless digital X-ray flat panel detector is substantially equivalent to the predicate devices on the Market (Mars1417V-PSI, K161730 ): Detective quantum efficiency (DQE), Quantum limited performance, Modulation transfer function (MTF), Effects of aliasing, Sensitivity linearity, Lag, Change in detection sensitivity, Dose requirement and reciprocity changes, Stability of device
- Nonclinical Considerations:
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[510(k)] Application
characteristics with time, Uniformity of device characteristic, Noise power spectrum(NPS), Spatial resolution, Image Acquisition time, and Black level. According to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software SDK classifies the hazards, defines requirements specification and design specification, all the specification pass the 16 test cases and complies the intended design specification.
4) Clinical Consideration:
Nonclinical information of Mars1417XF-GSI is sufficient to support the substantial equivalence of a subject to a predicate device (Mars1417V-PSI, K161730 ) for its modifications without the need to provide additional clinical data. The only change for the Mars1417XF-GSI is in the ADC Digitization and software. And for the communication function, the Mars1417XF-GSI reduce the wired communication function.
10. Conclusion [21 CFR 807.92(b)(3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, iRay Technology Taicang Ltd. Concludes that iRay Mars1417XF-GSI Wireless Digital Flat Panel Detectors is substantially equivalent to predicate device with regards to safety and effectiveness.
§ 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.