Mars1417V-TSI wireless digital flat panel detector and Mano4336W wireless digital flat panel detector are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.

Device Description

Mars1417V-TSI and Mano4336W Wireless Digital Flat Panel Detectors (Hereinafter referred to as Mars1417V-TSI and Mano4336W) are the kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 34.56cm×42.00cm. Mars1417V-TSI and Mano4336W are totally same except for label and model name.

The sensor plate of Mars1417V-TSI and Mano4336W is direct-deposited with CsI 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 Mars1417V-TSI and Mano4336W is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software.

iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.

AI/ML Overview

The provided text is a 510(k) summary for the iRay Technology Taicang Ltd. Wireless Digital Flat Panel Detectors (Models Mars1417V-TSI, Mano4336W). This document does not contain details about acceptance criteria, a specific study proving the device meets those criteria, or clinical performance data in the context of diagnostic accuracy. These types of studies (like MRMC or standalone performance evaluations with ground truth) are typically required for AI-powered diagnostic devices, which this is not.

This document focuses on establishing substantial equivalence to a predicate device (Mars1417XF-CSI, K182551) based on non-clinical performance characteristics, safety, and technological characteristics, rather than clinical performance for diagnostic tasks.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment for diagnostic accuracy cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria for diagnostic performance or present a table comparing such criteria to reported diagnostic performance. It focuses on technical specifications and safety standards.

Metric	Acceptance Criteria (Not explicitly stated for diagnostic performance)	Reported Device Performance (from "Technological Characteristic" and "Substantial Equivalence" sections)
Image Matrix Size	Refer to predicate device's performance	2304 × 2800 pixels (Proposed Device) vs. 2336× 2836 pixels (Predicate Device)
Pixel Pitch	Refer to predicate device's performance	150μm (Same for Proposed and Predicate)
ADC Digitization	Refer to predicate device's performance	16 bit (Same for Proposed and Predicate)
Effective Imaging Area	Refer to predicate device's performance	345.6 mm × 420.0 mm (Proposed Device) vs. 350.4 mm × 425.4 mm (Predicate Device)
Spatial Resolution	Refer to predicate device's performance	Min. 3.3lp/mm (Same for Proposed and Predicate)
Modulation Transfer Function (MTF)	Refer to predicate device's performance	0.68 at 1 lp/mm (Proposed Device) vs. 0.5 at 1 lp/mm (Predicate Device)
Detective Quantum Efficiency (DQE)	Refer to predicate device's performance	0.36 at 1 lp/mm (RQA5, 2.5µGy) (Proposed Device) vs. 0.37 at 1 lp/mm (RQA5, 2.5µGy) (Predicate Device)
Power Consumption	Refer to predicate device's performance	Max. 18W (Proposed Device) vs. Max. 19W (Predicate Device)
Communications (Wireless functionality)	Refer to predicate device's performance	Wired (only for service): Gigabit Ethernet; Wireless: IEEE 802.11a/b/g/n/ac (2.4 GHz / 5 GHz) (Proposed Device)Wireless: IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz) (Predicate Device)
Electrical Safety and EMC	Meet standard requirements (IEC/ES 60601-1, IEC 60601-1-2)	All test results meet standard requirements
Biological Evaluation	Assured safety (ISO 10993-1)	Evaluation results and test results assured safety the same as the predicate device

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The substantial equivalence argument relies on non-clinical performance and safety testing, not on a clinical test set for diagnostic accuracy with patient data.

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 because there was no clinical diagnostic performance study described. The document is about the technical specifications and safety of the X-ray detector, not an AI or diagnostic algorithm that requires expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there was no clinical diagnostic performance study described.

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 such study is mentioned or implied in this 510(k) summary. This device is a digital flat panel detector, a hardware component for X-ray imaging, not an AI-assisted diagnostic software.

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

No standalone diagnostic algorithm performance study is mentioned. This device is a digital flat panel detector, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical diagnostic performance study with ground truth was described.

8. The sample size for the training set

Not applicable, as this device is a hardware component and not an AI/ML algorithm that requires a training set of imaging data.

9. How the ground truth for the training set was established

Not applicable, as this device is a hardware component and not an AI/ML algorithm that requires a training set with established ground truth.

In summary: The provided 510(k) summary is for an X-ray detector, a hardware device. The equivalence argument is based on technical specifications, electrical safety, EMC testing, and biological evaluation, comparing it to a legally marketed predicate device. It does not involve AI/ML components or clinical diagnostic accuracy studies that would require the establishment of ground truth by experts from a sample of patient data. Therefore, most of the questions regarding clinical study design for diagnostic performance cannot be answered from this document.

Summary

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May 1, 2020

Image /page/0/Picture/1 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized caduceus. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

iRay Technology Taicang Ltd. % Meng Li Registration & Regulation Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA

Re: K201004

Trade/Device Name: Wireless Digital Flat Panel Detector (Models, Mars1417V-TSI, Mano4336W) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: April 10, 2020 Received: April 23, 2020

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 may, 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 aware 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 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

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality 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)

K201004

Device Name Wireless Digital Flat Panel Detector

Indications for Use (Describe)

Mars 1417V-TSI wireless digital flat panel detector and Mano436W wireless digital flat panel detector are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.

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)

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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)

K201004

1. Date Prepared [21 CFR 807.92(a)(1)]
  April 29th, 2020

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@iraygroup.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:	Mars1417V-TSI
	Mano4336W
Classification Name:	Stationary X-Ray System
Product Code:	MQB
Regulation Number:	21 CFR 892.1680
Device Class:	Class II

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4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[

The identification predicates within this submission are as follows:

Manufacturer:	iRay Technology Taicang Ltd.
Trade Name:	Wireless Digital Flat Panel Detector
Model Name:	Mars1417XF-CSI
Product Code:	MQB
Classification Name:	Stationary X-Ray System
Regulation Number:	21 CFR 892.1680
Device Class:	Class II
FDA 510 (k) #:	K182551

5. Description of the Device [21 CFR 807.92(a)(4)]

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6. Intended Use [21 CFR 807.92(a)(5)]

6.1. Indications for use

6.2. Suitable patient

It is suitable for providing digital X-ray imaging for DR system to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients, 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:	Proposed Device:
	Wireless Digital Flat PanelDetector	Wireless Digital Flat PanelDetector
510(K) Number	K182551	To be assigned
Intended Use	The Mars1417XF-CSIWireless Digital Flat PanelDetector is indicated for digitalimaging solution designed forproviding general radiographic	same
	Predicate Device:	Proposed Device:
Item	Wireless Digital Flat PanelDetector	Wireless Digital Flat PanelDetector
Indications forUse	system in all general-purposediagnostic procedures.The Mars1417XF-CSIWireless Digital Flat PanelDetector is indicated for digitalimaging solution designed forproviding general radiographicdiagnosis of human anatomy.We understand the Agency hasbecome aware of situationswhere solid state detectorsinserted into radiographicsystems adversely impacteddevice performance due toimproper integration(reference:http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM385149.pdf ).Below is a summary of theinformation from theMars1417XF-CSI usermanuals covering keyelectromechanical	Same with Mars1417XF-CSI,additionally, in the considerationof patient size (i.e., height,weight, body part thickness) andusable dose range, the detectorcould be used for general X raydiagnosis of usual body part forboth adults and pediatricpatients.
Item	Predicate Device:	Proposed Device:
	Wireless Digital Flat PanelDetector	Wireless Digital Flat PanelDetector
	and computer requirementsneeded for X-ray systeminterface and integration.1. Mechanical interfacerequirements.2. Computer requirements3. Data communicationinterface requirements4. Electrical powerrequirements5. X-ray trigger interfacerequirementsNeither the Mars1417XF-CSIdetector nor its software act asan X-ray generator controller,and therefore, the device is notsubject to Electronic ProductRadiation Control (EPRC)performance standards andreporting requirements.
ClassificationName	Stationary X-ray system	Same
Product Code	MQB	Same
RegulationNumber	21 CFR 892.1680	Same
Panel:	Radiology	Same
	Predicate Device:Wireless Digital Flat PanelDetector	Proposed Device:Wireless Digital Flat PanelDetector
Item
Classification:	II	Same
X-Ray Absorber(Scintillator):	CsI	Same
Installation Type:	Wireless, Portable	Same
ReadoutMechanism:	Thin Film Transistor	Same
Image MatrixSize:	2336× 2836 pixels	2304 × 2800 pixels
Pixel Pitch:	150μm	Same
ADC Digitization	16 bit	Same
Effective ImagingArea:	350.4 mm × 425.4 mm	345.6 mm × 420.0 mm
SpatialResolution:	Min. 3.3lp/mm	Same
ModulationTransferFunction(MTF)	0.5 at 1 lp/mm	0.68 at 1 lp/mm
DetectiveQuantumEfficiency(DQE)	0.37 at 1 lp/mm (RQA5,2.5µGy)	0.36 at 1 lp/mm (RQA5,2.5µGy)
PowerConsumption:	Max. 19W	Max. 18W
Item	Predicate Device:Wireless Digital Flat PanelDetector	Proposed Device:Wireless Digital Flat PanelDetector
Communications:(Wirelessfunctionality)	Wireless: IEEE 802.11a/b/g/n(2.4 GHz / 5 GHz)	a) Wired (only for service) :Gigabit Ethernet(1000BASE-T)b) Wireless: IEEE802.11a/b/g/n/ac (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 ~ +30°CHumidity: 10 ~ 80%(Non-Condensing)Atmospheric pressure: 70 ~106 kPaAltitude: Max. 3000 meters	Temperature: +5 ~ +35°CHumidity: 10 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~ 106kPaAltitude: Max. 3000 meters
Storage andTransportation:( detector )	Temperature: -20 ~ +50°CHumidity: 10 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~106 kPaAltitude: Max. 3000 meters	Temperature: -20 ~ +55°CHumidity: 5 ~ 95%(Non-Condensing)Atmospheric pressure: 70 ~ 106kPaAltitude: Max. 3000 meters
Software	iRay SDK(include iDetector) isintend to supply API interfacefor DR system manufacturers.DR system manufacturer	Same
	Predicate Device:	Proposed Device:
Item	Wireless Digital Flat PanelDetector	Wireless Digital Flat PanelDetector
	control the detector by SDKinterface. SDK is not intend touse directly by other usersbeside DR systemmanufacturers.
Utilized FDAguidancedocuments	1. Guidance for theSubmission of 510(k)'s forSolid State X-ray ImagingDevices;2. The 510(k) Program:Evaluating SubstantialEquivalence in PremarketNotifications[510(k)];3. Content of PremarketSubmissions forManagement ofCybersecurity in MedicalDevices;4. Radio Frequency WirelessTechnology in MedicalDevices.	Same with Mars1417XF-CSI,additionally:1. Guidance for "PremarketAssessment of PediatricMedical Devices";2. Guidance for "PediatricInformation for X-rayImaging Device PremarketNotifications".

7. Technological Characteristic [21 CFR 807.92(a)(6)]

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8. System requirements to operate with other radiographic system components

1. Recommended Generator Specification:
  Energy range: 40~150kVp

mA range: 10~1000mA (depending on the generator power)

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ms range: 10~~6300ms to produce 0.1~~1000mAs (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 the distributor or iRay's service office.

1. Application Program Interface (API) for system integration manufacturer Peripheral hardware: Mars1417V-TSI and Mano4336W connected via wireless communication.

Operating System:	Windows 7 32/64bit
CPU:	Intel Core i7 3.6G
Memory:	4G DDR3
Hard Disk:	640 G
LAN Card:	Intel Pro EXP9301CT PROGigabit Network Adapter with PCIe interface

1. X-ray exposure mode
  The AED trigger module is a unit can connect X-ray signal in the Mars1417V-TSI/Mano4336W. Once there is X-ray generator exposure exist, the AED 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)|

1. Electrical Safety and EMC testing: Electrical, mechanical, environmental safety 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.
1. Biological Evaluation:

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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.

1. Non-clinical Considerations:
  One modification from the predicate device to Mars1417V-TSI and Mano4336W is geometric design, related to Amorphous Silicon (A-Si) panel size. Another modification is wireless functionality, predicate device has higher wireless transmission speed.

The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' are substantially equivalent to the non-consideration of predicate devices on the Market (Mars1417XF-CSI, K182551).

1. Clinical Consideration:
  Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program and software keep the same with those of predicate device. Additionally, as mentioned in clinical considerations in 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices', clinical consideration may not necessary for changes in the dimensions of the image receptor with otherwise identical materials if non-clinical information is sufficient to support the substantial equivalence.

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 Mars1417V-TSI and Mano4336W are substantially equivalent to predicate device with regards to safety and effectiveness.

Regulation Number and Section

§ 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.