Venul 717X is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in general-purpose diagnostic procedures.

Device Description

Venu1717X is a cassette-size tethered X-ray flat panel detector based on amorphous silicon thin-film transistor technology. It is designed to provide the high quality radiographic image which contains an active matrix of 3070×3070 with 139um pixel pitch. The scintillator of Venu1717X is CsI(Caesium Iodide). The technology of CsI direct growth reduces the exposure dose and improves the image quality. Since Venu1717X supports multiple trigger modes, it can satisfy both of the general DR system and retrofit DR system.

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 intended to be used directly by other users beside DR system manufacturers. The iRay SDK is unchanged from the predicate device.

AI/ML Overview

The information provided indicates that the iRay Technology Taicang Ltd. Flat Panel Detector (Venu1717X) is a digital imaging solution for general radiographic diagnosis. While the provided text describes the device's technical specifications and non-clinical studies to establish substantial equivalence to a predicate device (Mars1717V-VSI, K201043), it does not contain details about specific acceptance criteria for diagnostic accuracy metrics (like sensitivity or specificity) for a clinical study.

Instead, the provided text focuses on demonstrating substantial equivalence primarily through technical performance characteristics and a "concurrence study" of clinical images.

Here's an attempt to answer your request based only on the provided text, highlighting what is available and what is missing:

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

The document does not explicitly state "acceptance criteria" in terms of diagnostic performance metrics for a clinical study (e.g., sensitivity, specificity, or AUC with target thresholds). It focuses on demonstrating equivalence through technical performance.

Criterion Type	Acceptance Criteria (Not explicitly stated as such for clinical performance in text)	Reported Device Performance (as presented)	Notes
Technical Performance	Demonstrated substantial equivalence to predicate device (Mars1717V-VSI, K201043)	Spatial Resolution: Min. 3.4 lp/mm (Predicate: Min. 3.6 lp/mm)	While the proposed device's spatial resolution is slightly lower than the predicate, the document likely considers this within acceptable variation for substantial equivalence, especially when considered with other factors.
		Modulation Transfer Function (MTF): 0.66 at 1 lp/mm (Predicate: 0.65 at 1 lp/mm)	Improved MTF compared to predicate.
		Detective Quantum Efficiency (DQE): 0.28 at 1 lp/mm (RQA5, 2.5µGy) (Predicate: 0.40 at 1 lp/mm (RQA5, 2.5µGy))	Note: The proposed device's DQE is lower than the predicate. This is a significant difference in a key image quality metric. The justification for substantial equivalence despite this difference is not explicitly detailed beyond the overall conclusion. It often implies that other aspects of performance or the context of use mitigate this difference for diagnostic purposes.
		Electrical Safety and EMC: Meet IEC/ES 60601-1, IEC60601-2-54, and IEC 60601-1-2 standards.	All test results reported to meet standard requirements.
		Biological Evaluation: Confirmed safety as predicate device per ISO 10993-1.	Evaluated and assured safety.
		Cybersecurity: Passed assessment related to Cybersecurity.	Passed the required assessments.
Clinical Performance	No significant difference between images of the proposed and predicate device.	"There was no significant difference between the images of the Venu1717X and those of the predicate device." (from a "concurrence study of 30 clinical images")	This is the closest statement to a clinical performance outcome. However, "no significant difference" is a qualitative assessment and not tied to specific quantitative diagnostic accuracy metrics. The study's purpose was to "provide further evidence in addition to the laboratory performance data to show that the complete system works as intended," rather than to establish diagnostic accuracy against a specific acceptance criterion.

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 for Test Set: 30 clinical images.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only states "Clinical images were provided".

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)

The document mentions a "concurrence study" but does not specify the number of experts, their qualifications, or how ground truth was established for the 30 clinical images. The statement "There was no significant difference between the images" implies a qualitative comparison by human readers, but details are missing.

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

The document does not specify any adjudication method for the "concurrence study" of the 30 clinical images.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study mentioned is a "concurrence study of 30 clinical images" comparing the proposed device to a predicate device, which is different from an MRMC study designed to assess reader improvement with AI assistance. The device itself is a Flat Panel Detector, which is hardware for image acquisition, not inherently an AI-driven diagnostic assistance tool.

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

This section is not applicable as the device is a Flat Panel Detector, a hardware component for imaging, not an AI algorithm performing diagnostic tasks in a standalone manner. The software mentioned (iRay SDK, iDetector) are for controlling the detector and integration, not for standalone diagnostic interpretation.

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

For the "concurrence study" of 30 clinical images, the type of "ground truth" and how it was established is not detailed. The study aimed to show "no significant difference" between images of the proposed and predicate device, rather than assessing diagnostic accuracy against an independent ground truth.

8. The sample size for the training set

This information is not applicable as the description refers to a medical imaging device (Flat Panel Detector) and its associated control software, not an AI model that would typically have a "training set" in the context of machine learning.

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

This information is not applicable for the same reasons as #8.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

June 29, 2022

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

Re: K221714

Trade/Device Name: Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: May 10, 2022 Received: June 13, 2022

Dear Guo Wu:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K221714

Device Name Flat Panel Detector

Indications for Use (Describe)

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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K221714 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)

1. Date Prepared [21 CFR 807.92(a)(1)]

April 15, 2022

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:	Guo Wu
Phone:	0512- 50720539
Fax:	0512- 50720539
Email:	guo.wu@iraygroup.com

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name:	Flat Panel Detector
Common Name:	Solid State X-Ray Imager
Model Name:	Venu1717X
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 Taicang Ltd.
Trade Name:	Wireless Digital Flat Panel Detector
Model Name:	Mars1717V-VSI
Product Code:	MQB

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Classification Name: Stationary x-ray system FDA 510 (k) #: K201043

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

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

6.1. Intended Use

Venu1717X is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including adults only. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. This equipment provides digital X-ray imaging for diagnosis of disease, injury, or any applicable health problem. The image is obtained as the result of X-ray passing through the human body and detected by the equipment.

iRay will provide equipment and software support for integration of system.

6.2. Suitable patient

This panel is not intended for mammography or dental applications, and not recommend for pregnant women and new born.

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

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health problem.

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

Item	Predicate Device:Wireless Digital Flat PanelDetector	Proposed Device:Flat Panel Detector
510(K) Number	K201043	K221714
Intended Use	The Mars1717V-VSI WirelessDigital Flat Panel Detector isindicated for digital imagingsolution designed for providinggeneral radiographic system inallgeneral-purpose diagnosticprocedures.	This equipment provides digital X-ray imaging for diagnosis ofdisease, injury, or any applicablehealth problem. The image isobtained as the result of X-raypassing through the human bodyand detected by the equipment.iRay will provide equipment andsoftware support for integration ofsystem.
Indications forUse	Mars1717V-VSI is indicated fordigital imaging solutionsdesigned to provide generalradiographic diagnosis for humananatomy including both adult andpediatric patients. It is intended toreplace film/screen systems in allgeneral-purpose diagnosticprocedures.	Venu1717X is indicated for digitalimaging solutionsdesigned to provide generalradiographic diagnosis for humananatomy including adults only. It isintended to replace film/screensystems in all general-purposediagnostic procedures.
ClassificationName	Stationary x-ray system	Same
Product Code	MQB	Same
Regulation Number	21 CFR 892.1680	Same
Panel	Radiology	Same
Classification:	II	Same
X-Ray Absorber(Scintillator):	CsI	Same
Installation Type:	Wireless, Portable	Wired, Portable
Detector structure:	Amorphous silicon TFT	Same
	Predicate Device:
Item	Wireless Digital Flat Panel	Proposed Device:
	Detector	Flat Panel Detector
Dimensions:	460 mm× 460 mm × 15 mm	Same
Image Matrix Size:	3072 × 3072 pixels	Same
Pixel Pitch:	139μm	Same
EffectiveImagingArea:	427mm×427mm	Same
ADCDigitization	16 bit	Same
Spatial Resolution	Min. 3.6lp/mm	Min. 3.4 lp/mm
ModulationTransferFunction (MTF)	0.65 at 1 lp/mm	0.66 at 1 lp/mm
DetectiveQuantumEfficiency(DQE)	0.40 at 1 lp/mm (RQA5, 2.5µGy)	0.28 at 1 lp/mm (RQA5, 2.5µGy)
Imaging protectPlate:	Carbon Fiber Plate	Same
Power Consumption:	Max. 30W	Max. 20W
Communications:	a) Wired (only forservice): GigabitEthernet (1000BASE-T)b) Wireless: IEEE802.11a/b/g/n/ac (2.4 GHz/ 5 GHz)	Wired: GigabitEthernet (1000BASE-T)
Cooling:	Air cooling	Same
Protection againstmatter/Water	IPX1	IPX1
Protection againstshock	Type B applied part	Same
Operation:	Temperature: +5 ~ +35°CHumidity: 5 ~ 95%(Non-Condensing)Atmospheric pressure: 55 ~106 kPaAltitude: Max. 3000 meters	Temperature: +5 ~ +35°CHumidity: 30 ~ 80%(Non-Condensing)Atmospheric pressure: 70 ~ 106kPaAltitude: Max. 3000 meters
Storage andTransportation:( detector )	Temperature: -10 ~ +55°CHumidity: 5 ~ 95%(Non-Condensing)	Temperature: 10 to 55°CHumidity: 10 ~ 90%(Non-Condensing)
Item	Predicate Device:Wireless Digital Flat PanelDetector	Proposed Device:Flat Panel Detector
	Atmospheric pressure: 55 ~106 kPaAltitude: Max. 3000 meters	Atmospheric pressure: 70 ~ 106kPaAltitude: Max. 3000 meters
Software	iDetector	iDetector

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iRay Technology Taicang Ltd.

[510(k)] Application

8. System requirements to operate with other radiographic system components

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

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

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 your distributor or iRay's service office.

1. Application Program Interface (API) for system integration manufacturer
  Peripheral hardware: Venu1717X connected via wired communication.

Operating System:	Windows 10 or above 32/64bit
CPU:	Intel Core i7 dual core, or even higher
Memory:	4G or higher
Hard Disk:	160 G or higher
LAN Card:	Intel Gigabit CT adapter Network Interface Cardor equivalent

1. X-ray exposure mode
  The inner trigger module is a unit can connect X-ray signal in the Venu1717X. 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.

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9. Nonclinical study

1. Electrical Safety and EMC testing:
  Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 and IEC60601-2-54 were 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:
  The top cover surface film and painting materials of the detector may contact patients'skin, this has been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device.
1. Nonclinical Considerations:
  According to the Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, the non-clinical studies have been performed and the results have shown that the Venu1717X is substantially equivalent to the predicate devices on the Market (K201043):

Dose to output signal transfer function, Signal to noise ratio, uniformity, Defect, Minimum triggering dose rate, Modulation transfer function (MTF), Spatial resolution, Low contrast resolution and Image Acquisition time. According to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software SDK(contains iDetector) classifies the hazards, defines requirements specification and design specification, all the specification pass all the test cases and complies the intended design specification.

1. Clinical Consideration:
  A concurrence study of 30 clinical images was conducted to compare the performance of the Venul 717X to that of the predicate device (Mars 1717V-VSI, K201043).

Clinical images were provided; these images were not necessary to establish substantial equivalence based on the differences from the predicate but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.

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There was no significant difference between the images of the Venu1717X and those of the predicate device.

1. Cybersecurity:
  According to the Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, the Venu1717X had passed the assessment related to Cybersecurity.

10. Conclusion

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 Venu1717X is 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.