The purpose of Visaris Avanse® is to acquire, store, communicate, display and process medical X-ray images. It offers features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and radiographers. Visaris Avanse supports printing to DICOM compatible printers. Within a network environment Visaris Avanse may provide other modalities with a DICOM worklist and a DICOM worklist service. Images and worklists can be sent and received using the DICOM protocol. Visaris Avanse has a modular system architecture. It consists of the basic application, processing and viewing as well as a number of other modules for image and worklist management, archiving, search and display. Beside the basic functionality Visaris Avanse also provides a user interface for generator control and image acquisition of medical images DR detectors.

Device Description

Visaris Avanse® is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detectors technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control, image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module). DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements.

AI/ML Overview

This document is a 510(k) premarket notification for the "Visaris Avanse®" device, which is a software for digital radiography imaging, control, and management. It focuses on establishing substantial equivalence to a predicate device, not on proving meeting acceptance criteria through a specific study with quantitative performance metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully extracted or are not directly applicable in the typical sense of AI/CADe device performance studies.

Here's a breakdown of what can be inferred and what is not available:

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

The document does not provide a table of explicit quantitative "acceptance criteria" and "reported device performance" in the context of clinical efficacy or diagnostic accuracy. Instead, the "acceptance criteria" for this submission are demonstrated through a comparison of technological characteristics with a predicate device, and verification/validation testing against in-house criteria.

Acceptance Criteria (Implicitly based on Predicate Equivalence and Functional Testing):
- Maintain same essential indications for use.
- Utilize same kind of platform (Windows PC).
- Perform similar software validation and panel testing.
- Be DICOM compatible.
- Handle JPEG images.
- Meet all in-house criteria demonstrated by Verification and Validation plan.
- Produce images of excellent diagnostic quality.
Reported Device Performance (Implicit, Qualitative, and Comparative):
- "The Visaris Avanse® has the same essential indications for use as the predicate and uses the same kind of platform (Windows PC) to perform its functions." (Substantial Equivalence Discussion)
- "The same kind of software validation and panel testing has been performed." (Substantial Equivalence Discussion)
- "It is DICOM compatible like the predicate and handles jpeq images like the predicate." (Substantial Equivalence Discussion)
- "The complete Visaris Avanse® PACS system configuration has been assessed and tested at the factory and has passed all in-house criteria." (Non clinical testing)
- "Validation testing indicate that as required by risk analysis, designated individuals performed all verification and validation activities and that the result demonstrated that the predetermine acceptance criteria were met." (Non clinical testing)
- "The images were evaluated by a board certified radiologist and were found to be of excellent diagnostic quality." (Clinical testing)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated. The "Clinical testing" section mentions "clinical images were obtained using each of the declared compatible digital panels." It does not specify the number of images or patients.
Data Provenance: Not specified. It only states "clinical images were obtained." Whether this was retrospective or prospective, or the country of origin is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: "A board certified radiologist" (singular) was used.
Qualifications: "Board certified radiologist." Specific experience (e.g., 10 years) is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not specified. Given there was only "a board certified radiologist," an adjudication method involving multiple readers is unlikely. This appears to be a single-reader evaluation.

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 Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. This submission is for a software device that acquires, stores, communicates, displays, and processes X-ray images, and provides a user interface for generator control. It is not an AI/CADe device designed to assist human readers in diagnosis or detection, so a study comparing human readers with and without AI assistance is not relevant to this device's function as described.

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

Standalone Study: No, this is not an AI/CADe algorithm for diagnosis. The "device" is the software itself, which facilitates image management and viewing. Its "performance" is assessed functionally (e.g., compatibility, image quality), not as a diagnostic algorithm. The clinical testing verifies the diagnostic quality of the images produced by the system, not the diagnostic performance of an algorithm.

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

Type of Ground Truth: The "ground truth" for the clinical testing appears to be the qualitative assessment by a board-certified radiologist that the images were "of excellent diagnostic quality." There's no mention of pathology, outcomes data, or a formal consensus process.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/not provided. This device is not an AI/ML algorithm that requires a training set in the conventional sense. It's a general-purpose image acquisition, processing, and management software.

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

How Ground Truth for Training Set was Established: Not applicable, as there is no mention of an AI/ML training set.

Summary

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

June 8, 2015

VISARIS d.o.o. Belgrade % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K150725

Trade/Device Name: Visaris Avanse® Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, LLZ Dated: May 12, 2015 Received: May 14, 2015

Dear Mr. Kamm:

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,

Robert A Ochs

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

Enclosure

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Indications for Use

510(k) Number (if known) K150725

Device Name Visaris Avanse®

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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1. Administrative Information

Reason for Submission:

510(k) Notification for Visaris Avanse®, a new device

Submitter:

Address:	VISARIS d.o.o. BelgradeBatajnički drum 10 deo 1b11080 ZemunSERBIA
Submission contact person:Contact telephone:Contact e-mail:Date prepared:Common device name:Classification:Regulation #s.:Product codes:	Mr. Milan Ratković+381 11 2017 631mratkovic@visaris.comMay 12, 2015Stationary X-Ray System (accessory)Class II21 CFR 892.1680 and 21 CFR 892.2050KPR and LLZ
Substantially equivalent device:
Device Name(s):	dicomPACS® 5.2 - dicomPACS DX-R® 1.6
Manufacturer:	Oehm & Rehbein GmbH
Product Code:	LLZ
Regulation Number:	21 CFR 892.2050
Common Product Name:	Radiological Image Processing System
510(k) Number:	K091364

2. Device description: 21 CFR 807 92 (a) (4)

3. Indications for Use: 21 CFR 807 92 (a) (5)

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system architecture. It consists of the basic application for image acquisition, processing and viewing as well as a number of other modules for image and worklist management, archiving, search and display. Beside the basic functionality Visaris Avanse® also provides a user interface for generator control and image acquisition of medical images DR detectors. Not intended for mammography.

4. Technological characteristics: 21 CFR 807 92 (a) (6)

Visaris Avanse/PACS ® has a modular system architecture. It consists of the basic application for image acquisition, processing and viewing as well as a number of other modules for image and worklist management, archiving, search and display. The software has been validated for compatibility with digital panels previously cleared by FDA and has been validated for control compatibility with the following list of generators:

Manufacturer	Product Name
Sedecal, Spain	All models
Claymount, Switzerland	Clayrad Series
Spellman, Germany	HFe Series
EMD, Canada	All models
CPI, Canada	Indico100, CMP

The image formats used are: DICOM, TIFF, BMP, PNG, JPEG, RAW (new)

Image Compression:

Visaris Avanse/PACS use the following compression methods within the DICOM standard:

JPEG Baseline (Process 1): Lossy JPEG 8 Bit Image Compression .
JPEG Extended (Process 2 & 4): Lossy JPEG 12 Bit Image Compression (Process 4 . only)
JPEG Extended (Process 3 & 5) ●
JPEG Spectral Selection. Non-Hierarchical (Process 6 & 8) ●
JPEG Lossless, Non-Hierarchical (Process 14) ●
JPEG Lossless, Non-Hierarchical, First-Order Prediction (Process 14 [Selection Value . 11)
JPEG-LS Lossless Image Compression
JPEG-LS Lossy (Near-Lossless) Image Compression ●
JPEG 2000 Image Compression (Lossless Only)
JPEG 2000 Image Compression ●

These compression methods are defined in the DICOM standard. Support of them is optional.

The modules are:

1. Avanse® DR image acquisition module
1. X-ray Generator Control Module
1. Minet Server internal communication module
1. CDViewer module
1. RIS Interface module
1. Avanse® DR service shell module
1. VisarisPACS database module
1. Worklist Server module
1. Dics Burn server module

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Worklist generator module

1. Diagon DICOM image viewer module
  The interfaces are:
1. DR flat panel
1. X-ray generator
1. HTTP
1. DICOM Store (SCP)
1. DICOM Send (SCU)
1. DCIOM Print (SCU)
1. Worklist Query (SCP)

5. Non clinical testing

The complete Visaris Avanse® PACS system configuration has been assessed and tested at the factory and has passed all in-house criteria. The Verification and Validation plan was design to evaluate all input and output functions, and actions performed by Visaris Avanse® PACS software in each operation mode and followed the process documented in the Validation Test Plan. Validation testing indicate that as required by risk analysis, designated individuals performed all verification and validation activities and that the result demonstrated that the predetermine acceptance criteria were met. If the device is installed by Visaris, installation and integration verification tests are conduct against acceptance criteria prior to release to client.

6. Clinical testing

Clinical images were obtained using each of the declared compatible digital panels. The images were evaluated by a board certified radiologist and were found to be of excellent diagnostic quality.

7. Substantial Equivalence Discussion

The Visaris Avanse® has the same essential indications for use as the predicate and uses the same kind of platform (Windows PC) to perform its functions. The same kind of software validation and panel testing has been performed. It is DICOM compatible like the predicate and handles jpeq images like the predicate.

dicomPACS®5.2 and dicomPACS DX-RK091364, Oehm und Rehbein GmbH(Predicate Device)	VISARIS AVANSE®(New Device)[Equivalence Level]	Equivalence Justification
Design
Overall software architecture:A front-end + back-end architecture.Front-end includes user interface realisedthrough „stand-alone" user applications.Back-end includes image and metadatadatabases and background services thatoperate on them. Front and back end arelinked through DICOM standard protocolcommunication. DICOM communicationrealised trough service provider-clientmodel, back end provides the service andfront end is its client.	Overall software architecture:A front-end + back-end architecture.Front-end includes user interface realisedthrough „stand-alone" user applications.Back-end includes image and metadatadatabases and background services thatoperate on them. Front and back end arelinked through DICOM standard protocolcommunication. DICOM communicationrealised trough service provider-clientmodel, back end provides the service andfront end is its client.[EQUIVALENT]	None required. They areEQUIVALENT.
dicomPACS®5.2 and dicomPACS DX-RK091364, Oehm und Rehbein GmbH	VISARIS AVANSE®(New Device)	Equivalence Justification
(Predicate Device)Software architecture back end:Integrated database of image, examinationand patient data linking acquired image fileson the file system (local or network storage).Windows services (background processeswith no user interface) handle data transferto and from database and ensure databaseintegrity.	[Equivalence Level]Software architecture back endIntegrated database of image, examinationand patient data linking acquired image fileson the file system (local or network storage).Windows services (background processeswith no user interface) handle data transferto and from database and ensure databaseintegrity.[EQUIVALENT]	None required.They areEQUIVALENT.
Software architecture front end:Front end is realised throught several staticwindows (win32) applications implementingmain user interface functionality includingimage acquisition, exam scheduling andimage review.Only one application entity active on theuser interface at any time.Win32 applications implementDICOMcommunication clients to communicatewith services in the back-end and externalDICOM services.	Software architecture front end:Front end is realised throught several staticwindows (win32) applications implementingmain user interface functionality includingimage acquisition, exam scheduling andimage review.Only one application entity active on theuser interface at any time.Win32 applications implement DICOMcommunication clients to communicatewith services in the back-end and externalDICOM services.Exam scheduling user interface is alsorealised through web based interface.[PRACTICALLY EQUIVALENT]	Web interface architectureis used to collect user input,but not process it. Mainprocessing functionality isstill performed in the backend and the web interfaceis implemented on a win32process within a browser.
Communication to external components:Realised through eachcomponent'sproprietary communication protocol usingstandard interface/data exchange protocols(such as RS232 or TCP-IP). Connections tocomponents managed locally on the mainsystem PC through component proprietarysoftware (SDK) interfaces implemented indynamicly linked libratries (dlls).Communication from main system softwarerealised through direct calls to exposedfunctions of the SDK contained within thedlls. Data transfer realised through commonmemory access.	Communication to external components:Realised through eachcomponent'sproprietary communication protocol usingstandard interface/data exchange protocols(such as RS232 or TCP-IP). Connections tocomponents managed locally on the mainsystem PC through component proprietarysoftware (SDK) interfaces implemented indynamicly linked libratries (dlls).Communication from main system softwarerealised through direct calls to exposedfunctions of the SDK contained within thedlls. Data transfer realised through commonmemory access.[EQUIVALENT]	None required.They areEQUIVALENT.
dicomPACS®5.2 and dicomPACS DX-RK091364, Oehm und Rehbein GmbH(Predicate Device)	VISARIS AVANSE®(New Device)[Equivalence Level]	Equivalence Justification
User Interface designMultiple application enetites with relatedbut separate user interface to coverdifferent workflow aspects (DR/CRacquisition and patient entry, databasesearch, image viewing, examinationscheduling).User interface is graphical with clear displayof acquired or retreived images and systeminformation on the screen as well as dataentry fields.Action commands are input by the user asmouse clicks on command buttons, menus,results lists and data entry fields.Textual data input is handled throughkeyboard/touchscreen keyboard input.	User Interface designMultiple application enetites with relatedbut separate user interface to coverdifferent workflow aspects (DR/CRacquisition and patient entry, databasesearch, image viewing, examinationscheduling).User interface is graphical with clear displayof acquired or retreived images and systeminformation on the screen as well as dataentry fields.Action commands are input by the user asmouse clicks on command buttons, menus,results lists and data entry fields.Textual data input is handled throughkeyboard/touchscreen keyboard input.[EQUIVALENT]	None required. They areEQUIVALENT.
Development Platform:Main development platform MicrosoftWindows development platform (.NETTechnologies: ADO.NET Entity Framework,LINQ, ADO.NET, XML, ODATA Protocol,Native: ODBC, ADO, MSDASQL, Database:SQL Serever Database Engine, SQL ServerIntegration Services SSIS, SQL ServerReporting Services SSRS).	Development Platform:Main development platform MicrosoftWindows development platform (.NETTechnologies: ADO.NET Entity Framework,LINQ, ADO.NET, XML, ODATA Protocol,Native: ODBC, ADO, MSDASQL, Database:SQL Serever Database Engine, SQL ServerIntegration Services SSIS, SQL ServerReporting Services SSRS). Android mobileplatform used for UI extension to mobiledevices.[PRACTICALLY EQUIVALENT]	Main development platformis equivalent. Androidplatform is additionally usedon Visaris Avanse only tocollect user actions frommobile devices. Systemactions are not processedon this platform, rather onthe same main platform aspredicate device.Functionality verified.
PC Platform	PC Platform
Common Personal Computer (PC) platform,static or mobile (laptop, tablet).	Common Personal Computer (PC) platform,static or mobile (laptop, tablet).[EQUIVALENT]	None required. They areEQUIVALENT.
Material	Material
Software only product, no materialincluded.	Software only product, no materialincluded.[EQUIVALENT]	None required. They areEQUIVALENT.
Chemical Composition	Chemical Composition
Software only product, no chemicalcomposition.	Software only product, no chemicalcomposition.[EQUIVALENT]	None required. They areEQUIVALENT.
Energy Source	Energy Source
Software only product, no energy sourceincluded.	Software only product, no energy sourceincluded.[EQUIVALENT]	None required. They areEQUIVALENT.

Substantial Equivalence Table

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Substantial Equivalence Conclusion: After analyzing software validation, risk analysis, and clinical images, it is the conclusion of VISARIS d.o.o. Belgrade Inc that the VISARIS AVANSE® is as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.

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.