Yushan X-Ray Flat Panel Detector with DROC by InnoCare Optoelectronics Corp.

The Wireless/Wired 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, fluoroscopy, tomography, and angiography applications.

Device Description

InnoCare's Yushan X-Ray Flat Panel Detector with DROC, model F14C, F14G are portable digital detector system. 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 F14C, F14G support both wireless and wired/tethered data communication between the detector and the system. 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, roundededge 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 by using DROC(Digital Radiography Operating Console). 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

This document describes the premarket notification for the "Yushan X-Ray Flat Panel Detector with DROC," models F14C and F14G. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K201528).

Acceptance Criteria and Device Performance:

The document focuses on non-clinical performance data to demonstrate substantial equivalence. It does not provide a table of acceptance criteria with specific numerical targets for particular metrics (e.g., sensitivity, specificity, or specific image quality metrics like DQE or MTF at certain conditions) and corresponding reported performance values for a clinical study with a human-in-the-loop component or standalone AI performance.

Instead, the performance data presented primarily confirms adherence to voluntary standards and established guidance documents for X-ray imaging devices. The comparison table (pages 6-7) outlines technical specifications of the new device and the predicate.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a "table of acceptance criteria" with numerical performance targets for an AI algorithm's diagnostic performance. The context is a 510(k) submission for an X-ray flat panel detector, not an AI diagnostic software. Therefore, the "acceptance criteria" discussed are related to the hardware's technical specifications and compliance with established standards, and the "reported device performance" are measurements of these technical specifications and confirmations of compliance.

Technical Characteristic	Acceptance Criterion (Predicate Device K201528)	Reported Performance (New Device F14C, F14G)
Scintillator	V14G: GOS, V14C: CsI, V17G: GOS, V17C: CsI, V17Ge: GOS	F14G: GOS, F14C: CsI
Pixel Pitch	140 µm	140 µm
DQE (at 1 lp/mm, RQA5)	GOS: 0.27, CsI: 0.48	GOS: 0.27, CsI: 0.50
MTF (at 1 lp/mm, RQA5)	GOS: 0.52, CsI: 0.69	GOS: 0.52, CsI: 0.63
Max. Resolution	GOS: 3.57 lp/mm, CsI: 3.57 lp/mm	GOS: 3.57 lp/mm, CsI: 3.57 lp/mm
A/D Conversion	16 bit	16 bit
Dimensions (WxLxH)	V14G/V14C: 460x383x15mm, V17G/V17C/V17Ge: 460x460x15mm	F14G/F14C: 460x383x15mm
Weight	V14G/V14C: 2.7 Kg, V17G/V17C/V17Ge: 3.2-3.5 Kg	F14G: 2.3 Kg, F14C: 2.5 Kg
Substrate	Glass	Non-Glass (polyethylene terephthalate laminate)
Interface	Wired: Gigabit Ethernet, Wireless: IEEE802.11 ac/a/g/n	Wired: Gigabit Ethernet, Wireless: IEEE802.11 ac/a/g/n
Biocompatibility	All material contact with patients in accordance with ISO 10993.	All material contact with patients in accordance with ISO 10993.
EMC	Compliance with IEC60601-1-2, FCC 47 CFR PART 15 SUBPART B, ETSI EN 301 489-17 V3.1.1:2017 and ETSI EN 301 489-1 V2.1.1:2017	Demonstrated compliance through testing.
Load-bearing & Ingress Protection	Tested and passed	Tested and passed.

Key finding for substantial equivalence: "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." (Page 10)

2. Sample Size for the Test Set and Data Provenance:

The document states: "Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies." (Page 10)

Therefore, there is no "test set" in the context of clinical image data for evaluating AI or human reader performance. The "testing" referred to is for the physical and electrical characteristics of the device. The data provenance is non-clinical, likely laboratory measurements conducted by the manufacturer, InnoCare Optoelectronics Corp. in Tainan City, Taiwan (R.O.C.).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable, as no clinical study or test set for diagnostic performance (such as for an AI algorithm) was used.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical study or test set for diagnostic performance was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. The device is an X-ray detector, not an AI-powered diagnostic tool requiring this type of clinical evaluation. The submission relies on non-clinical data to demonstrate substantial equivalence to the predicate device.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is an X-ray detector, a hardware component for acquiring images, not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is established through objective measurements of technical specifications (e.g., DQE, MTF, pixel pitch), and compliance with recognized industry standards (IEC, ISO, FCC, etc.) and FDA guidance documents for medical devices. There is no biological or diagnostic ground truth (e.g., pathology, outcomes data, or expert consensus on disease presence) associated with this submission, as it relates to the performance of the image acquisition hardware.

8. The Sample Size for the Training Set:

Not applicable. The device is hardware, an X-ray detector, not an AI algorithm that requires a training set of images.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for an AI algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

InnoCare Optoelectronics Corp. % Yumei Cheng Principal Engineer Rm. B, No. 2, Sec. 2, Huanxi Rd., Xinshi Dist., Tainan City 744 Taiwan (R.O.C.) Tainan City, Taiwan (R.O.C.) 744 TAIWAN

Re: K210988

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: March 15, 2021 Received: April 8, 2021

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

April 21, 2021

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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 (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)

K210988

Device Name

Yushan X-Ray Flat Panel Detector with DROC

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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Section 5 510(k) Summary

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: Mar 15, 2020

II. DEVICE

Trade name: Yushan X-Ray Flat Panel Detector with DROC Model name: F14C, F14G 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 with DROC FDA 510(k) clearance number: K201528 Manufacturer: InnoCare Optoelectronics Corp. Decision Date: 10/11/2020 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

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

FDA-Summary-A1 2of8

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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 (F14C, F14G) and its predicate device, K201528, Yushan X-Ray Flat Panel Detector with DROC (V14C, V14G, V17C, V17G, V17Ge) are portable digital detector systems. 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, K201528. 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 2 models in this submission, F14C, F14G, which are the serial models using the same user interface, DROC. The only difference is F14C, F14G is using a non-glass substrate, while the models in K201528 are using glass substrate, no further change to device functionality, operation and mechnism.

Product name	Yushan X-Ray Flat Panel Detectorwith DROC	Yushan X-Ray Flat Panel Detectorwith DROC
Model name	F14G	V14G
	F14C	V14C
		V17G
		V17C

Please refer to the following table for more detailed information.

FDA-Summary-A1 3of8

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			V17Ge
Manufacturer	InnoCare Optoelectronics Corp.	InnoCare Optoelectronics Corp.	InnoCare Optoelectronics Corp.
Qualifiednumber	-	-	CE2460/K201528
	Clinical
Intended use	The Wireless/Wired Yushan X-RayFlat Panel Detector with DROC isintended to capture for display ra-diographic images of human anat-omy. It is intended for use in gen-eral projection radiographic appli-cations wherever conventionalfilm/screen or CR systems may beused. The Yushan X-Ray FlatPanel Detector with DROC is notintended for mammography, fluo-roscopy, tomography, and an-giography applications.	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 for use in generalprojection radiographic applica-tions wherever conventionalfilm/screen or CR systems may beused. The Yushan X-Ray FlatPanel Detector with DROC is notintended for mammography, fluo-roscopy, tomography, and an-giography applications.
Compliancestandard	- FDA Standards 21 CFR892.1680 for stationary x-raysystemEuropean Medical DevicesDirective (93/42/EEC)EN ISO 13485ISO 14971	- FDA Standards 21 CFR892.1680 for stationary x-raysystemEuropean Medical DevicesDirective (93/42/EEC)EN ISO 13485ISO 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	- 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
	Technical
Dimensions(mm)	F14G:460(W)×383(L)×15(H)F14C:460(W)×383(L)×15(H)	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)

Weight (Kg)	F14G: 2.3F14C: 2.5	V14G: 2.7V14C: 2.7V17G: 3.2V17C: 3.2V17Ge: 3.5
Substrate	Non-Glass(polyethylene terephthalate laminate)	Glass

Scintillator	F14G: GOSF14C: CsI	V14G: GOSV14C: CsIV17G: GOSV17C: CsIV17Ge: GOS
Pixel Pitch	140 µm	140 µm
DQE	GOS: at 1 lp/mm, RQA5 is 0.27CsI: at 1 lp/mm, RQA5 is 0.50	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 0.63	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 Conver-sion	16 bit	16 bit
Pixels	F14G: 2500 x 3052F14C: 2500 x 3052	V14G: 2500 x 3052V14C: 2500 x 3052V17G: 3072 x 3072V17C: 3072 x 3072V17Ge: 3072 x 3072
Interface	Wired: Gigabit Ethernet(100BASE-TX or 10BASE-T)Wireless: IEEE802.11 ac /a/g/n	Wired: Gigabit Ethernet(100BASE-TX or 10BASE-T)Wireless: IEEE802.11 ac /a/g/n* V17Ge is not applicable forwireless function.
Power Source	Rechargeable Lithium Battery	Rechargeable Lithium Battery* V17Ge is not applicable
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)- Power supply (Adapter)- SE cable (Back-up cable)- Power Cord (Optional)- Charger (Optional)- Charger Adapter (Optional)- DROC Dongle (Optional)	- Battery (Optional)* V17Ge isnot applicable- Power supply (Adapter)- SE cable (Back-up cable)- Power Cord

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VI. PERFORMANCE DATA

Non-clinical Performance Data: Yushan X-Ray Flat Panel Detector with DROC (F14C, F14G) 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; 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 301 489-17 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 con-

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firmed 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 (F14C, F14G) is as safe and effective as the legally marketed device Yushan X-Ray Flat Panel Detector with DROC (V14C, V14G, V17C, V17G, V17Ge) (K201528), and do not raise different questions of safety and effectiveness than K201528.

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.