The Wireless(V14C, V14G, V17C, V17G)/Wired(V14C, V14G, V17C, V17G, V17Ge) Yushan X-Ray Flat Panel Detector with DROC is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector with DROC is not intended for mammography, tomography, and angiography applications.

Device Description

InnoCare's Yushan X-Ray Flat Panel Detector with DROC, model V14C, V14G, V17C, V17G are portable digital detector system, while V17Ge is a non-protable digital detector. The Yushan X-Ray Flat Panel Detector with DROC is designed to be used in any environment that would typically use a radiographic cassette for examinations. Model V14C, V14G, V17C, V17G support both wireless and wired/tethered data communication between the detector and the system, while model V17Ge is only applicable for wired use. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. Every model have memory exposure mode, and extended image readout feature. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water.

The Yushan X-Ray Flat Panel Detector with DROC is currently indicated for general projection radiographic applications and offers two different detector types in terms of scintillator materials (gadolinium oxysulfide (GOS) and cesium iodide (CsI)).

The Yushan X-Ray Flat Panel Detector with DROC sensor can automatically collects x-ray images from an x-ray source. It collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided and controlled by independent system manufacturers. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images.

Yushan series is working due to the combination of SDK(software development kit) and DROC(Digital Radiography Operating Console).

The SDK provides the interface for DROC to control the Yushan X-Ray Flat Panel Detector. SDK initiates the taking of X-ray images from the Yushan X-Ray Flat Panel Detector, through the Sensor Driver application. Once an X-ray is taken, Sensor Driver reads it from the flat panel and transfers it to SDK. Then the DROC will take the image data from SDK for further image process and display.

The DROC is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function include:

1. Detector status update
1. Xray exposure workflow
1. Image viewer and measurement.
1. Post image process and DICOM file I/O
1. Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network

AI/ML Overview

The provided text describes the Yushan X-Ray Flat Panel Detector with DROC, a device for capturing radiographic images. However, it does not include detailed acceptance criteria or a study proving its performance against such criteria in the way typically expected for an AI/CADe device.

The document is a 510(k) summary for a medical device that integrates software (DROC) for processing, annotating, and storing x-ray images, but the primary device is still a flat panel detector. The regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device, not on specific AI performance metrics or clinical studies comparing AI-assisted vs. non-AI-assisted reads.

Here's a breakdown of the requested information based on the provided text, and where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated for AI performance)	Reported Device Performance (Related to image quality and features)
Image Quality: Substantial equivalence to predicate device.	Image quality evaluation confirmed equivalence to predicate.
Compliance with voluntary standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-1-6, ANSI AAMI IEC 62366-1 and ANSI/AAMI HE75).	Device confirms to all listed standards.
Compliance with FDA guidance for Solid State X-ray Imaging Devices.	Followed FDA guidance for submission of 510(k)s for Solid State X-ray Imaging Devices.
Wireless features testing (FCC, ETSI).	Passed FCC 47 CFR PART 15 SUBPART C, FCC 47 CFR PART 15 SUBPART E, FCC SAR, ETSI EN 301 489-17 V3.1.1:2017, and ETSI EN 301 489-1 V2.1.1:2017.
Software Level of Concern: Moderate.	Determined to be Moderate based on "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Cybersecurity risks addressed.	Cybersecurity risks addressed through device risk analysis, controls treated and implemented.
Load-bearing characteristics and protection against ingress of water.	Tested and passed.
Biocompatibility with ISO 10993 series.	Demonstrated through ISO 10993 series.
DQE at 1 lp/mm, RQA5	GOS: 0.27; CsI: 0.48
MTF at 1 lp/mm, RQA5	GOS: 0.52; CsI: 0.69
Max resolution	GOS: 3.57 lp/mm; CsI: 3.57 lp/mm
A/D Conversion	16 bit

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not mentioned for any AI/software performance evaluation. The document states "No clinical study has been performed." The "image quality evaluation" mentioned is a non-clinical study, but details about the number of images/phantoms used are not provided.
Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not mentioned. The document focuses on demonstrating substantial equivalence through non-clinical performance and engineering tests, rather than a clinical study requiring expert ground truth for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable as there is no described clinical test set with ground truth established by experts.

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 MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study has been performed." and "The substantial equivalence has been demonstrated by non-clinical studies."

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

The document implies that an "image quality evaluation" was performed for the device's output. While the DROC includes processing software, the submission appears to treat it as an integral part of the flat panel detector system rather than a separate AI algorithm with standalone performance metrics. No specific standalone algorithm performance (e.g., sensitivity, specificity for a specific condition) is provided or discussed, as the device's primary function is to capture and display radiographic images, not to automatically interpret them or provide diagnoses.

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

For the non-clinical image quality evaluation, the ground truth would likely be based on established physical phantoms and objective measurements (e.g., DQE, MTF under controlled conditions) rather than expert consensus on clinical findings, pathology, or outcomes data, as no clinical study was performed.

8. The sample size for the training set

Not applicable / Not mentioned. The device is a flat panel detector system. While it has software (DROC) for image processing and display, the document does not describe it as an AI/CADe device that performs automated diagnostic interpretations requiring a training set in the conventional sense. The "processing software" mentioned is for general image display and manipulation, not for machine learning-based diagnostic assistance.

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

Not applicable / Not mentioned. (See point 8).

Summary

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October 11, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

InnoCare Optoelectronics Corp. % Yumei Cheng Senior Engineer Rm. B, No. 2, Sec. 2, Huanxi Rd., Xinshi Dist., Tainan City, Taiwan 744 REPUBLIC OF CHINA

Re: K201528

Trade/Device Name: Yushan X-Ray Flat Panel Detector with DROC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: June 2, 2020 Received: August 31, 2020

Dear Yumei Cheng:

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

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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 (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 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.

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)

K201528

Device Name

Yushan X-Ray Flat Panel Detector with DROC

Indications for Use (Describe)

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)	X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K201528

I. SUBMITTER

InnoCare Optoelectronics Corp. Rm. B, No. 2, Sec. 2, Huanxi Rd., Xinshi Dist., Tainan City 744, Taiwan (R.O.C.) TEL: +886-6-700-7238 # 22598 Email: yumei.cheng@innocare-x.com Contact Person: Yumei Cheng / Senior Engineer Date Prepared: Jun 02, 2020

II. DEVICE

Trade name: Yushan X-Ray Flat Panel Detector with DROC Model name: V14C, V14G, V17C, V17G, V17G, V17Ge Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680 Device class: Class II

III. PREDICATE DEVICE

Substantial equivalence to the following predicate device is as follows: Trade/Device Name: Yushan X-Ray Flat Panel Detector FDA 510(k) clearance number: K191939 Manufacturer: InnoCare Optoelectronics Corp. Decision Date: 08/29/2019 Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680 Device class: Class II

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IV. DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFI-CATION

Yushan series is working due to the combination of SDK(software development kit) and DROC(Digital Radiography Operating Console).

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the image data from SDK for further image process and display.

The DROC is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function include:

1. Detector status update
1. Xray exposure workflow
1. Image viewer and measurement.
1. Post image process and DICOM file I/O
1. Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network

The software level of concern for the Yushan X-Ray Flat Panel Detector with DROC has been determined to be moderate based on the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

The cybersecurity risks of the Yushan X-Ray Flat Panel Detector with DROC have been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation, and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g., requirements, verification).

V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Yushan X-Ray Flat Panel Detector with DROC (V14C, V14G, V17C, V17G) and its predicate device, Yushan X-Ray Flat Panel Detector (V14C, V14G) are portable digital detector systems, while the model V17Ge is a non-portable type, that are used to acquire x-ray exposures. Yushan X-Ray Flat Panel Detector with DROC has the same Indications for Use, and very similar functional and technical requirements as the predicate device, K191939. The comparison of technological characteristics are listed in the following table. Yushan X-Ray Flat Panel Detector with DROC has been successfully tested and validated, there are 5 models in this submission, V14C, V14G, V17C, V17G, V17Ge, and V14C, V14G are exactly the same device in K191939 named V14C and V14G, except for the modification of the user interface which has

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been changed into DROC version, and V17C, V17G, V17Ge are the serial models using the same user interface, DROC. Please refer to the following table for more detailed information.

Product name	Yushan X-Ray Flat Panel Detectorwith DROC	Yushan X-Ray Flat Panel Detector
Model name	V14GV14CV17GV17CV17Ge	V14GV14C
Manufacturer	InnoCare Optoelectronics Corp.	InnoCare Optoelectronics Corp.
Qualifiednumber	-	K191939
Clinical
Indications foruse	The Wireless(V14C, V14G, V17C,V17G)/Wired(V14C, V14G,V17C, V17G, V17Ge) Yushan X-Ray Flat Panel Detector withDROC is intended to capture fordisplay radiographic images ofhuman anatomy. It is intended foruse in general projection radio-graphic applications whereverconventional film/screen or CRsystems may be used. The YushanX-Ray Flat Panel Detector withDROC is not intended for mam-mography, fluoroscopy, tomogra-phy, and angiography applications.	The Wireless/Wired Yushan X-RayFlat Panel Detector is intended tocapture for display radiographicimages of human anatomy. It isintended for use in general projec-tion radiographic applicationswherever conventional film/screenor CR systems may be used. TheYushan X-Ray Flat Panel Detectoris not intended for mammography,fluoroscopy, tomography, and an-giography applications.

	- FDA Standards 21 CFR- 892.1680 for stationary x-ray- system- European Medical Devices- Directive (93/42/EEC)- EN ISO 13485- ISO 14971- ANSI/AAMI ES60601-1- CAN/CSA C22.2 No. 60601-- 1:14- IEC 60601-1-2- IEC 62304- IEC 60601-1-6- IEC 62366-1- ISO 10993-1- ISO 10993-5- ISO 10993-10- ISO 15223-1	- FDA Standards 21 CFR- 892.1680 for stationary x-ray- system- European Medical Devices- Directive (93/42/EEC)- EN ISO 13485- ISO 14971- ANSI/AAMI ES60601-1- CAN/CSA C22.2 No. 60601-- 1:14- IEC 60601-1-2- IEC 62304- IEC 60601-1-6- IEC 62366-1- ISO 10993-1- ISO 10993-5- ISO 10993-10- ISO 15223-1
Compliancestandard	Technical
	V14G:460(W)×383(L)×15(H)V14C:460(W)×383(L)×15(H)V17G:460(W)×460(L)×15(H)V17C:460(W)×460(L)×15(H)V17Ge:460(W)×460(L)×15(H)	V14G:460(W)×383(L)×15(H)V14C:460(W)×383(L)×15(H)
Dimensions(mm)
Weight (Kg)	V14G: 2.7	V14G: 2.7

	V14C: 2.7	V14C: 2.7
	V17G: 3.2
	V17C: 3.2
	V17Ge: 3.5
Scintillator	V14G: GOS
	V14C: CsI
	V17G: GOS	V14G: GOS
	V17C: CsI	V14C: CsI
	V17Ge: GOS
Pixel Pitch	140 μm	140 μm
DQE	GOS: at 1 lp/mm, RQA5 is 0.27CsI: at 1 lp/mm, RQA5 is 0.48	GOS: at 1 lp/mm, RQA5 is 0.27CsI: at 1 lp/mm, RQA5 is 0.48
MTF	GOS: at 1 lp/mm, RQA5 is 0.52CsI: at 1 lp/mm, RQA5 is 0.69	GOS: at 1 lp/mm, RQA5 is 0.52CsI: at 1 lp/mm, RQA5 is 0.69
Max.resolution	GOS: 3.57 lp/mmCsI: 3.57 lp/mm	GOS: 3.57 lp/mmCsI: 3.57 lp/mm
A/D Conversion	16 bit	16 bit
Pixels	V14G: 2500 x 3052
	V14C: 2500 x 3052
	V17G: 3072 x 3072	V14G: 2500 x 3052
	V17C: 3072 x 3072	V14C: 2500 x 3052
	V17Ge: 3072 x 3072
Interface	Wired: Gigabit Ethernet(100BASE-TX or 10BASE-T)Wireless: IEEE802.11 ac /a/g/n* V17Ge is not applicable forwireless function.
		Wired: Gigabit Ethernet(100BASE-TX or 10BASE-T)Wireless: IEEE802.11 ac /a/g/n
Power Source	Rechargeable Lithium Battery* V17Ge is not applicable	Rechargeable Lithium Battery
Biological
Biologicalsafety	All material contact with patientsare in accordance with ISO 10993.	All material contact with patientsare in accordance with ISO 10993.
Others
Accessories	- Battery (Optional)* V17Ge isnot applicable- Power supply (Adapter)- SE cable (Back-up cable)- Power Cord	- Battery (Optional)- Power supply (Adapter)- SE cable (Back-up cable)- Power Cord

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INCX

VI. PERFORMANCE DATA

Non-clinical Performance Data: Yushan X-Ray Flat Panel Detector with DROC (V14C, V14G, V17C, V17G, V17Ge) confirms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-1-6, ANSI AAMI IEC 62366-1 and ANSI/AAMI HE75. In addition, the FDA's Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (issued on September 1, 2016) was followed to describe the detector characteristics; Radio Frequency Wireless Technology in Medical Devices (issued on August 14, 2013), FCC 47 CFR PART 15 SUBPART C, FCC 47 CFR PART 15 SUBPART E and FCC SAR were followed to test the wireless features, which V17Ge is not applicable for this test; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued on May 11, 2005) was followed to evaluate the level of concern as moderate; Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued on October 2, 2014) was also followed to consider issues related to cybersecurity in the design and development process of this device. Additionaly, the risk analysis, necessary verification and validation activities were performed. Load-bearing characteristics and protection against ingress of water were tested and passed. The internal circuit design was demonstrated through EMC emission testing: IEC60601-1-2, FCC 47 CFR PART 15 SUBPART B, ETSI EN 301 489-

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17 V3.1.1:2017 and ETSI EN 301 489-1 V2.1.1:2017, and the results were satisfactory. Biocompatibilities were demonstrated through ISO 10993 series to prove the using material safe and effective. Furthermore, the image quality evaluation confirmed that the image quality of the Yushan X-Ray Flat Panel Detector with DROC is substantially equivalent to that of the predicate device.

Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.

VII. CONCLUSIONS

Yushan X-Ray Flat Panel Detector with DROC is substantially equivalent to the predicate device in technical characteristics, design features, operating principles, functional and performance characteristics, and for the intended uses in the stated medical specialties.

Yushan X-Ray Flat Panel Detector with DROC is designed to comply with applicable federal and international safety and performance standards.

Based upon the supporting data summarized above, we concluded the Yushan X-Ray Flat Panel Detector with DROC (V14C, V14G, V17C, V17G, V17Ge) is as safe and effective as the legally marketed device Yushan X-Ray Flat Panel Detector (Yushan V14C, Yushan V14G) (K191939), and do not raise different questions of safety and effectiveness than K191939.

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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.