Restore PACS is a device that receives digital medical images and data from various sources (such as, MR scanners, CT Scanners, Digital Xray systems, computers, image gateways or other image sources). Images and other medical data can be communicated, processed, managed, manipulated, stored and displayed within the system and/or across computer networks at distributed locations. Typical users of this system are trained radiologists, technicians and nurses.

Device Description

Restore PACS include features that receives digital medical images and data from various sources (such as, MR scanners, CT Scanners, Digital Xray systems, computers, image gateways or other image sources). Images and other medical data can be communicated, processed, managed, manipulated, stored and displayed within the system and/or across computer networks at distributed locations.

Restore PACS is designed to be deployed over TCP/IP networking infrastructure available in customer sites and utilizes commercially available hardware and operating systems. The system of Restore PACS does not generate any original medical images in the Restore PACS are received from DICOM compliant systems.

AI/ML Overview

The provided text does not contain typical acceptance criteria for a medical device that involves an algorithm with measurable performance characteristics (like sensitivity, specificity, or accuracy). Instead, the document describes the substantial equivalency of a Picture Archiving and Communication System (PACS), a software product. The "acceptance criteria" discussed are largely related to its functional performance and compatibility with different hardware and software configurations, rather than a clinical accuracy metric.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document frames "acceptance criteria" in terms of successful validation testing for various configurations and functionalities. It does not provide quantitative performance metrics like sensitivity, specificity, or AUC as one might expect for an AI diagnostic device. Instead, the performance is described as meeting "predetermined acceptance criteria" and verifying "no impact on safety or efficacy" and "no additional risks."

Acceptance Criteria Category	Reported Device Performance
Workstation OS Compatibility	Restore PACS 2.0 tested and validated with Windows 7 professional 32 bit and 64bit. Results verified no impact on safety or efficacy and no additional risks.
Server Configuration	Restore PACS 2.0 tested and validated on server configuration of Windows Server 2012, Enterprise Edition 64 bit, Microsoft SQL Server 2012, Enterprise Edition and 8 G Memory. Results verified no impact on safety or efficacy and no additional risks.
Workstation Configuration	Restore PACS 2.0 tested and validated on workstation configuration of Intel Processor, 2 Cores, 2.0 GHz and 4G Memory. Results verified no impact on safety or efficacy and no additional risks.
General Functions	Passed all in-house testing criteria including evaluation of all input functions, output functions, and actions performed by Restore PACS. Predetermined acceptance criteria were met as required by risk analysis. Compared to predicate (K150707 IntelePACS™), it has identical or equivalent features (e.g., Network, User interaction/input, Acquisition devices, Image search, Import/Export Image, Image Archive function, Image View, Image Measurement, Image Annotation, Image Manipulation, Post image data processing, Image Pan, Image Thumbnail viewing, Image Magnify Glass, DICOM 3.0 compatibility, Multi-user, Image organization, Image operations, Security, RAW Image data processing, Image reset, panning, Fit image).

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

Test Set Sample Size: Not specified. The document only mentions "the Restore PACS has been assessed and tested at the factory" and "Verification & Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed." There is no mention of a specific number of cases, images, or patients used for testing.
Data Provenance: Not specified. There is no information regarding the country of origin of any data used for testing, nor whether it was retrospective or prospective. Given the nature of a PACS, the testing would likely involve simulated or real medical imaging data, but details are absent.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document states that "designated individuals performed all verification and validation activities," but their qualifications are not detailed. Standard PACS validation would typically involve IT professionals, medical imaging experts (radiologists, technicians), and engineers, but this is not explicitly stated.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given that the testing focused on functional verification and validation rather than diagnostic performance, an adjudication method for "ground truth" (in a clinical sense) is not described or likely applicable in the way it would be for an AI diagnostic algorithm.

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

MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported. This device is a PACS (Picture Archiving and Communication System), which is an infrastructure for managing and displaying images, not an AI diagnostic algorithm designed to assist human readers in interpretation or improve their performance. Therefore, such a study would not be relevant for this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. The Restore PACS is not an "algorithm only" device in the diagnostic sense. It's a system for managing and displaying images that humans (radiologists, technicians, nurses) interact with. Its performance is evaluated on its functional capabilities (e.g., image communication, processing, storage, display) and lack of adverse impact on safety or efficacy, not on standalone diagnostic accuracy.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not explicitly stated as "ground truth" in the clinical sense. For this PACS device, the "ground truth" for the validation appears to be defined by functional requirements and specifications (e.g., does it correctly receive, store, display images as intended? Does it communicate properly across networks?). The "results of testing verified that there is no impact on safety or efficacy and that no additional risks have been identified" suggests validation against established functional and safety protocols, rather than clinical diagnostic ground truth.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a PACS, a software system, not a machine learning or AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.

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

September 2, 2016

XIAN WINGSPAN ELECTRONIC TECHNOLOGY CO., LTD. % Echo Chou OA Engineer Rm. A608, Pioneering Square, No. 48 Keji Rd., Gaoxin Dist. Xi'an, Shaanxi 710075 CHINA

Re: K162141 Trade/Device Name: Restore PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 3, 2016 Received: August 5, 2016

Dear Echo Chou:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K162141

Device Name Restore PACS

Indications for Use (Describe)

Restore PACS is a device that receives digital medical images and data from various sources (such as, MR scanners, CT Scanners, Digital Xray systems, computers, image gateways or other image sources). Images and other medical data can be communicated, processed, manipulated, stored and displayed within the system and/or across computer networks at distributed locations. Typical users of this system are trained radiologists, technicians and nurses.

Contraindications:

Restore PACS is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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SECTION 05: 510(K) SUMMARY

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date Prepared: July 29, 2016

Submitter's Information:

Company name Xi'an Wingspan Electronic Technology Co., Ltd. Rm. A608, Pioneering Square, No. 48 Keji Rd., Gaoxin Dist., Xi'an, Shaanxi, China Address Contact Name Echo Chou Title QA Engineer Phone number Fax number 86-29-88328071-817 Email e echo@wingspan.cn

Trade Name, Common Name and Classification:

Name of Device:	Restore PACS
Common Name:	Picture Archiving and Communication System
Classification:	21 CFR 892.2050, System, Image Processing, Radiological
Regulatory Class:	II
Product Code:	LLZ

Predicate Device:

Restore PACS is substantially equivalent to: K150707 510(k) Number: Trade/Device Name: IntelePACS™ Product Code: LLZ Original Applicant INTELERAD MEDICAL SYSTEMS INCORPORATED Decision Date May 27, 2015

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Device Description:

Indications for Use:

Contraindications:

Technological Characteristics with Predicate Device:

Restore PACS is a software product that handles and manipulates digital medical images. In general, a PACS (Picture Archiving and Communication System) is a medical imaging technology which provides storage of, and convenient access to, images from multiple modalities. Electronic images and reports are transmitted digitally via PACS; this eliminates the need to manually file, retrieve, or transport film jackets. The universal format for PACS image storage and transfer is DICOM 3.x (Digital Imaging and Communications in Medicine). Non-image data, such as scanned documents, may be incorporated using consumer industry standard formats like PDF (Portable Document Format), once encapsulated in DICOM. The predicate device and the new device are compared below:

Item	IntelePACS(K150707)	Restore PACS(Subject Device)	SubstantialEquivalenceAnalyses
WorkstationOperating System	Windows 7 64-bitProfessional	Windows 7 64-bit or32 bit Professional	Difference – Seeexplanation in A.
Network	10/100/100 Ethernet	10/100/100 Ethernet	Identical
User interaction/input	Mouse, keyboard, touch monitor	Mouse, keyboard	Equivalent - Restore PACS does not provide touch monitor
Acquisition devices	CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways	CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways	Identical
Image search	Yes	Yes	Identical
Import/Export Image	Yes	Yes	Identical
Image Archive function	Yes	Yes	Identical
Image View	Yes	Yes	Identical
Image Measurement	Yes	Yes	Identical
Image Annotation	Yes	Yes	Identical
Image Manipulation	Yes	Yes	Identical
Post image data processing	Yes	Yes	Identical
Image Pan	Yes	Yes	Identical
Image Thumbnail viewing	Yes	Yes	Identical
Image Magnify Glass	Yes	Yes	Identical
DICOM 3.0 compatibility	Yes	Yes	Identical
Multi-user	Yes - at a time, only one user can use it	Yes	Identical
Image organization	Patient ID, Name, study instance UID	Yes	Identical
Image operations	Yes	Yes	Identical
Security	Yes (Priority by user)	Yes	Identical
RAW Image data processing	Yes	Yes	Identical
Image reset	Yes	Yes	Identical
panning	Yes	Yes	Identical
Fit image	Yes	Yes	Identical
Server OperatingSystem	Red Hat EnterpriseLinux 6, latest Update,for 64-bit x86	Windows Server 2012,Enterprise Edition	See explanation in B
Server Memory	16 Gigabytes	8 Gigabytes	See explanation in B
Server Database	Sybase and PostgreSQL	Microsoft SQL Server2012, EnterpriseEdition.	See explanation in B
WorkStationProcessor	Intel 6-core XeonProcessor 3.2GHz	Intel Processor, 2Cores, 2.0 GHz	See explanation in C
Workstation Memory	6 Gigabytes	4 Gigabytes	See explanation in C

Restore PACS - Traditional 510(k)

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Restore PACS - Traditional 510(k)

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A. Workstation Operating System: Restore PACS has been tested and validated with Windows 7 professional 32 bit and 64bit, the results of testing verified that there is no impact on safety or efficacy and that no additional risks have been identified.
B. Restore PACS 2.0 has been tested and validated on server configuration of Windows Server 2012, Enterprise Edition 64 bit, Microsoft SQL Server 2012, Enterprise Edition and 8 G Memory, the results of testing verified that there is no impact on safety or efficacy and that no additional risks have been identified.
C. Restore PACS 2.0 has been tested and validated on workstation configuration of Intel Processor, 2 Cores, 2.0 GHz and 4G Memory, the results of testing verified that there is no impact on safety or efficacy and that no additional risks have been identified.

Non-Clinical Testing

The Restore PACS has been assessed and tested at the factory and has passed all in-house testing criteria. The Verification & Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the Restore PACS and followed the process documented in the Validation Test Plan. Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.

The subject of this submission did not require animal testing, sterility testing, electrical safety testing or electromagnetic compatibility testing.

Conclusion

Comparison of the Indications for Use, the technological characteristics, and performance specifications demonstrate the functional equivalence of the subject device to the predicate device. The subject device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The subject and predicate devices are substantially equivalent in the areas of technical characteristics, general function, and intended use.

Restore PACS - Traditional 510(k)

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Nonclinical testing results demonstrate the difference to the subject device does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices. Information provided in this premarket notification submission supports the Restore PACS to be as safe, as effective and substantially equivalent to its predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).