ExamVue Duo is a software for the acquisition, processing, storage and viewing of digital radiology studies. ExamVue Duo is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects. ExamVue Duo is indicated for use in general imaging including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.

ExamVue Duo is not indicated for use in mammography.

Device Description

The ExamVue Duo software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors and (optionally) generators and manufacturer supplied software for the acquisition and storage of digital x-ray studies. The ExamVue Duo software then provides a user interface for the viewing, annotating, and other workstation functions.

Exam Vue DR includes the ability to receive patient information and send studies to remote destinations using the DICOM 3.0 protocol.

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) Premarket Notification for the ExamVue Duo device does not include the specific details of a clinical study or performance data that would enable me to fulfill your request.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (ExamVue DR) rather than providing detailed acceptance criteria and a standalone study proving the device meets those criteria.

Here's why I cannot provide the requested information based on the given text:

No Acceptance Criteria Table or Reported Performance: The document lists characteristics for comparison between the proposed device (ExamVue Duo) and the predicate (ExamVue DR), but it doesn't define quantitative acceptance criteria for parameters like sensitivity, specificity, accuracy, or other performance metrics. It primarily states "SAME" or lists technical specifications (e.g., RAM, Processor) rather than clinical performance data.
Absence of a Clinical Study Description: The document states "Bench tests reports and clinical data have been provided, detailing the direct comparison of functions between the ExamVue Duo and predicate device" (Page 4). However, the actual reports or detailed methodology of such "clinical data" are not included in this 510(k) summary. It vaguely refers to "direct comparison of functions," which likely means comparing the implementation of features rather than a clinical outcome study.
No mention of AI/Algorithm-Specific Performance: The document describes ExamVue Duo as "software for the acquisition, processing, storage and viewing of digital radiology studies." While it mentions "image processing," there is no indication that the device includes an AI/ML algorithm that would necessitate specific performance metrics like those typically associated with AI-driven diagnostic aids (e.g., AUC, sensitivity, specificity for disease detection). The "added functions" like "Auto Stitching" and "Bone Suppression (option)" appear to be standard image processing features, not necessarily AI.
No Details on Ground Truth Establishment, Experts, Adjudication, or MRMC Studies: Since no clinical study evaluating specific performance metrics is described in the provided text, there are no details about sample size, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or how ground truth was established for a test set.

In summary, the provided document is a 510(k) submission showing substantial equivalence, not a detailed clinical study report. It compares the technical specifications and general functions of the new device to a previously cleared one. Therefore, I cannot extract the specific information you are looking for regarding acceptance criteria and a study proving those criteria are met for an AI/CAD/similar device.

Summary

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February 18, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is a seal with an eagle-like figure. To the right of the seal, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in blue, with the word 'ADMINISTRATION' written in a smaller font size below.

JPI Healthcare Co, Ltd. % William Little Senior Product Manager JPI Healthcare Solutions. Inc 52 Newtown Plaza PLAINVIEW NY 11803

Re: K213057

Trade/Device Name: ExamVue Duo Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: February 8, 2022 Received: February 10, 2022

Dear William Little:

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

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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 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,

Laurel Burk Assistant Director Diagnostic X-ray Systems Team 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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Indications for Use

510(k) Number (if known) K213057

Device Name ExamVue Duo

Indications for Use (Describe)

Exam Vue Duo is a software for the acquisition, processing, storage and viewing of digital radiology studies. Exam Vue Duo is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects. Exam Vue Duo is indicated for use in general imaging including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.

Exam Vue Duo is not indicated for use in mammography.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	X
Over-The-Counter Use (21 CFR 801 Subpart C)

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K213057 510 (k) Summary

April 12, 2021

1. Company and Correspondant Making the Submission:

Name: JPI Healthcare Co,. LTD Address: 608-ho, 28, Digital-ro 33-gil, Guro-gu, 08377 Seoul, Korea Telephone: +82-2-2108 - 2580 Fax: +82-2-2108-1180 Contact: Lee Jang Won Website: http://www.jpi.co.kr/

2. Identification of Device

Classification Name:	Stationary x-ray system
Common Name:	Digital X-ray Acquisition Software
Trade/Proprietary Name:	ExamVue Duo

3. Predicate Device

Manufacturer:	JPI Healthcare Solutions, Inc
Device:	ExamVue DR
510(k) Number:	K142930
Classification Name:	Stationary x-ray system
Common Name:	Digital X-ray Acquisition Software
Regulatory Number:	21 CFR 892.1680
Regulatory Class:	II
Product Code:	90 KPR

Product Classification Names and Citations 4.

Regulatory Number:	21 CFR 892.1680
Regulatory Class:	II
Product Code:	90 KPR

5. Description:

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Exam Vue DR includes the ability to receive patient information and send studies to remote destinations using the DICOM 3.0 protocol.

1. Indication for use
  ExamVue Duo is a software for the acquisition, processing, storage and viewing of digital radiology studies. ExamVue Duo is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects.

ExamVue Duo is indicated for use in general imaging, specialist imaging including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.

ExamVue Duo is not indicated for use in mammography.

1. Comparison with Predicate Device:
  JPI Healthcare Co., Ltd. believes that the ExamVue Duo software is substantially equivalent to the ExamVue DR software registered by JPI Healthcare Co. Ltd The ExamVue Duo software and the predicate device both -Provide a user interface for the registration, acquisition, and evaluation of x-ray studies. -Perform the functions of image transfer, image acquisition, image processing, and maintaining a patient database. -Use the DICOM 3.0 standard for medical imaging -Are intended for installation on Windows operating systems for use in a medical environment. -Interface with and process images from multiple models of hardware.

ExamVue Duo and the predicate device share the same essential functions of image acquisition, transfer, and processing; however they have different user interfaces and ExamVue Duo has some additional registration, annotation and imaging processing features. We believe this does not represent a substantial difference between the two devices, as the user interface presents the same essential data and supports similar workflow as the predicate device.

8. Safety, EMC and Performance Data

Bench tests reports and clinical data have been provided, detailing the direct comparison of functions between the ExamVue Duo and predicate device.

1. Conclusions:
  In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification JPI Healthcare Co., Ltd. concludes that the ExamVue PACS is safe and effective and substantially equivalent to predicate devices as described herein.

A detailed comparison supporting this conclusion can be found in Exhibit 1, Substantial Equivalence Chart.

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EXHIBIT 1

SUBSTANTIAL EQUIVALENCE CHART

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Characteristics	ProposedExamVue Duo	Predicate 1ExamVue DR
Manufacturer	JPI Healthcare Solutions, Inc	JPI Healthcare Solutions, Inc
510(k) Number		K142930
Intended use.	The ExamVue Duo software isdesigned for use by radiologistsand radiology technicians for theacquisition of digital x-ray images. Itinterfaces with 3rd party digital x-raydetectors or CR scanners andmanufacturer supplied software forthe acquisition and storage of digitalx-ray images. The ExamVueDuo software then provides a userinterface for the viewing,annotating, and other workstationfunctions. ExamVue Duo softwareincludes the ability to receivepatient information and send x-rayimages to remote destinationsusing the DICOM 3.0 protocol.	The ExamVue DR software isdesigned for use by radiologistsand radiology technicians forthe acquisition of digital x-rayimages. It interfaces with 3rdparty digital x-ray detectors orCR scanners and manufacturersupplied software for theacquisition and storage of digitalx-ray images. The ExamVue DRsoftware then provides a userinterface for the viewing,annotating, and otherworkstation functions. ExamVueDR includes the ability toreceive patient information andsend x-ray images to remotedestinations using the DICOM3.0 protocol.
PerformanceStandard	21 CFR 82021 CFR 830	SAME
Processor	Intel Core i5 or higher	Intel Core i5 or higher
RAM	8GB or higher	Min. 4GB
Hard Disk	Min. 500GByte	Min. 500GByte
Network	1GBit	1GBit
OperatingSystemRequirements	Windows 10	Windows 7, Windows 8 orWindows 10
Resolution	Min. 1366 x 768	1920 x 1080
ImageTransfer	DICOM 3.0 Standard	Same
ImageAcquisition	Yes	Yes
ImageProcessing	Yes	Yes
Windowing	Yes	Yes
ImageFormatting	Yes (1x1, 1x2, 2x1, 2x2, 3x3)	Yes (1x1, 1x2, 2x1, 2x2, 3x3)
AnnotationsandMeasurements	Yes	Yes
ImageRotation	Yes	Yes
Zoom	Yes	Yes
PatientDatabase	Yes	Yes
DICOMWorklist	Yes	Yes
DICOM Store	Yes	Yes
DICOM Print	Yes	Yes
DetectorSpecific	No	No
X-rayGeneratorControl	Yes	Yes
SW Ver.	ExamVue Duo – 1.0	ExamVue DR - 1.0
AddedFunctions	- Auto Stitching- Bone Suppression (option)- Chiropractic measurement features (option)- Podiatry measurement tools (option)

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Summary

The pre / post image processing algorithm is the same for ExamVue DR and ExamVue Duo. -
The measurement features for Chiropractic and Podiatry in ExamVue Duo are additional features. -However, they are similar to the measurement function of length and angle already incorporated in ExamVue DR (Ver 1.0). For the user convenience, a specific region of interest for chiropractic and podiatry was designated as a dedicated in ExamVue Duo (Ver 1.0).
-In Conclusion, the intended use and environment of the device is the same as the predicate devices, with only minor differences in features that are not integral to the function of the device. The differences do not introduce a fundamentally new scientific technology.

The intended use and environment of the device is the same as the predicate devices, with only minor differences in features that are not integral to the function of the device. For this reason, we believe it is substantially equivalent to the predicate devices.

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.