Zenis is intended for viewing of images acquired from Fluoroscopic X-ray system when installed on suitable commercial-standard PC hardware. Zenis is intended for use as a primary diagnostic and analysis workstation in Radiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration.

Device Description

Zenis is a PC-based DICOM workstation platform which provides scalable image and data management solutions for medical imaging. This software-based product provides capabilities for the acceptance, transmission, printing, display, storage, editing and digital processing of medical images and associated data. Zenis may be combined with a PACS network or connected directly to a modality through the use of DICOM networking.

AI/ML Overview

The provided text is a 510(k) summary for the Zenis Picture Archiving and Communications System (PACS). This document primarily focuses on establishing substantial equivalence to a predicate device (GE Medical Systems Information Technologies RA600) rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in a typical AI/ML medical device context.

Based on the provided text, the following points can be extracted or reasonably inferred, but many of the requested details are not available as this document is not a performance study report for a novel AI algorithm.

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

The document does not explicitly state quantitative acceptance criteria for device performance as would be found in a study for a new diagnostic algorithm. Instead, it relies on the concept of substantial equivalence to an existing predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Functions and characteristics are substantially similar to predicate device (RA600).	"Zenis & RA600 are intended for use as PACS software used for viewing of medical images acquired from modality when installed on suitable commercial-standard PC hardware."
Device is safe and effective.	"The result of performance test and clinical evaluation indicates that the new device is as safe and effective as the predicate devices."

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

The document mentions "performance test and clinical evaluation" but does not provide any details on the sample size used, the type of data (e.g., specific image modalities or pathology types), or its provenance (country of origin, retrospective/prospective). This is typical for a PACS system which is a general image management and viewing device, not a diagnostic algorithm analyzed for specific performance metrics on a dataset of cases.

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

This information is not provided. As the device is a PACS system for image viewing and management, the concept of "ground truth" as it applies to diagnostic accuracy for an AI algorithm is not directly relevant here. The evaluation would likely focus on system functionality, image quality for viewing purposes, and adherence to DICOM standards, not diagnostic accuracy against a ground truth.

4. Adjudication method for the test set

This information is not provided. See the explanation for point 3.

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 or reported. The Zenis device is a PACS system, not an AI-assisted diagnostic tool. Therefore, the concept of improving human readers with AI assistance does not apply in this context.

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

Not applicable. The Zenis device is a PACS system, not a standalone diagnostic algorithm.

7. The type of ground truth used

Not applicable in the context of diagnostic accuracy. For a PACS system, "ground truth" would relate to the accurate display, storage, and transmission of medical images as per DICOM standards and clinical requirements. The document implies that the "performance test and clinical evaluation" would have verified these aspects.

8. The sample size for the training set

Not applicable. As a PACS system, this device is not an AI/ML algorithm that undergoes a "training" phase with a specific dataset.

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

Not applicable. See explanation for point 8.

In summary:

The provided 510(k) summary for the Zenis PACS focuses on establishing substantial equivalence based on the device's functions and characteristics being "almost same" as the predicate device (RA600). It makes a general claim that "performance test and clinical evaluation indicates that the new device is as safe and effective as the predicate devices," but it does not provide any specific details about the methodology, data sets, expert involvement, or quantitative results that would typify a study validating a diagnostic AI device against explicit acceptance criteria and ground truth.

Summary

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Exhibit 5 510(k) Summary

AUG 26 2011

Picture archiving and communications system / Model: Zenis

1. Company and Correspondent making the submission
- 1.1 Submitter and US Official Correspondent

Submitter: GENORAY Co., Ltd. Address: #512, Byucksan Technopia, 434-6, Sangdaewon 1-dong, Jungwon-gu, Seongnam-city, Gyeonggi-do, 462-716 Korea Telephone No.: +82-31-740-4100 Fax: +82-31-737-8025

1.2 Official Correspondent (U.S): Jae Kim Business Manager Correspondent: GENORAY America Inc. 1073 N. Batavia St. Orange, CA 92867, USA Address: Telephone No.: 714-289-8020 Fax: 714-453-9661 Email: jae@genoray.com
1. Establishment Registration Number 3005843418
1. Device Information

Proprietary/Trade Name:	Picture archiving and communications system/ Model: Zenis
Common/Usual Name:	Picture archiving and communications system
Classification Name:	System, Image Processing, Radiological
Product Code:	LLZ
Device Class:	Class II per regulation 21 CFR 892.2050

1. Equivalent Legally Marketed Device

Manufacturer:	GE Medical Systems Information Technologies
Device Name:	RA600
510(k) Number:	K042525 (Decision Date - October 1, 2004)
Classification:	System, Image Processing, Radiological: LLZ,Class II per regulation 21 CFR 892.2050

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5. Description of the Device

Zenis may be combined with a PACS network or connected directly to a modality through the use of DICOM networking.

6. Indications for use

7. Safety and Effectiveness, comparison to Predicate

Zenis, which is made by GENORAY Co., Ltd., is substantially equivalent to RA600 of GE healthcare. We selected the RA600 as the predicate device already FDA approved. Because of RA600 and Zenis are almost same in function & characteristic. Zenis & RA600 are intended for use as PACS software used for viewing of medical images acquired from modality when installed on suitable commercial-standard PC hardware. The result of performance test and clinical evaluation indicates that the new device is as safe and effective as the predicate devices.

Conclusion 8.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 GENORAY Co., Ltd., concludes that the Picture archiving and communications system (Model: Zenis) is safe and effective and substantially equivalent to the predicate device as described above.

GENORAY Co., Ltd.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The image is in black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Genoray Co., Ltd. % Mr. Jae Kim Business Development Manager Genoray America, Inc. 1073 N. Batavia St. ORANGE CA 92867

ANG 2 5 2011

Re: K103181

Trade/Device Name: Picture archiving and communications system (Models: Zenis) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 15, 2010 Received: July 8, 2011

Dear Mr. Kim:

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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, perroits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free miber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary S. Patil

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for use Exhibit 4

510(k) number (if known): `K|0318|

· Device Name: Picture archiving and communications system (Models: Zenis)

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K103181

CONFIDENTIAL

Regulation Number and Section

N/A