VixWin Platinum is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

Device Description

VixWin Platinum Software has the following functionality which compares with the functionality provided for VixWin PRO predicate cleared under K060178. The functionality has been updated to remove legacy hardware no longer supported by the VixWin Platinum Software.

Controls scanning and intake of x-ray images from imaging plates with the Photo-Stimulable ● Phosphor (PSP) scanners.
Controls the direct capture of x-ray images from intra-oral sensors and extra-oral systems. ●
Allows View and capture color images from intra-oral and extra-oral cameras. ●
. Export and import digital images (such as those obtained by scanning a film).
. Process images with dental specific tools to enhance their diagnostic value.
. Analyze and enhance images to gather additional diagnostic information which may not be immediately apparent on initial visual inspection.
Obtaining and storing patient data pertaining to those images
Both the viewing of the images and storage of the images and their associated data. ●
Managing (locally and remotely) a database of patients and related data.
Allows the update of existing patient information and the creation and storage of new patient information in a database over the network.
. Allows access to patient files from multiple workstations via network connectivity.
. Allows printing images and image related information over the network.

VixWin Platinum can be utilized either locally or over a networked environment. If VixWin Platinum is installed on several computers, the patient and image database can be shared among them and used from different workstations.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the device "VixWin Platinum." This document is a regulatory submission for a medical device that aims to demonstrate its substantial equivalence to a legally marketed predicate device, not typically a study proving performance against acceptance criteria for an AI/ML device in the sense of accuracy, specificity, or sensitivity. Therefore, much of the requested information (sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not present in this type of regulatory submission.

The document primarily focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than a quantitative performance study.

Here's an analysis based on the provided document:

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

There are no specific quantitative "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, AUC) or reported performance metrics against such criteria in this document. The "performance" described relates to the functionality of the software.

Acceptance Criteria (Implied)	Reported Device Performance (as described in the document)
Functional Equivalence to Predicate	VixWin Platinum performs equivalently in functionality to the cleared VixWin PRO (K060178). All internal verification and validation has been completed, demonstrating functional equivalence.
Compatibility with updated software/hardware environments	VixWin Platinum operates on newer Windows operating systems (Windows 8, 7, Vista, XP) and server environments (2003, 2008), with higher RAM and storage requirements appropriate for modern systems.
Maintenance of core imaging functionalities	Controls capture, display, enhancement, and saving of digital images; processes images with dental-specific tools; analyzes and enhances images; obtains and stores patient data; manages patient and image database; allows printing.
Support for varied imaging modalities	Controls scanning and intake of x-ray images from PSP scanners; controls direct capture of x-ray images from intra-oral sensors and extra-oral systems; allows view and capture color images from intra-oral and extra-oral cameras; exports/imports digital images (e.g., scanned film).
No New Safety or Effectiveness Concerns	The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is safe and effective.

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

Not applicable / Not provided. The document states that "All internal verification and validation has been completed," but does not detail a specific test set, its size, or data provenance for proving diagnostic performance equivalence. The comparison is primarily structural and functional.

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)

Not applicable / Not provided. Ground truth establishment is not mentioned as part of this type of regulatory submission for a Picture Archiving and Communication System (PACS) software primarily focused on processing and displaying images.

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

Not applicable / Not provided.

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

Not applicable / Not provided. This device is a PACS software, not an AI-assisted diagnostic tool.

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

Not applicable / Not provided. This is a PACS software, not an autonomous algorithm for diagnosis.

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

Not applicable / Not provided. The "performance data" refers to functional verification and validation that the software operates as intended and equivalently to its predicate, not against a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

Not applicable / Not provided. This software is not an AI/ML model that would require a distinct training set in the conventional sense.

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

Not applicable / Not provided.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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

August 26, 2014

Imaging Sciences International (dba Gendex LLC, Dexis LLC) Sanjay Ahuja Director of Regulatory Affairs 1910 North Penn Road HATFIELD PA 19440

Re: K141451

Trade/Device Name: VixWin Platinum Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 1, 2014 Received: August 1, 2014

Dear Dr. Ahuja:

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.

FDA

for

Janine M. Morris 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) K141451

Device Name VixWin Platinum

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(K) Summary

VixWin Platinum

Submitter's Name, Address, Telephone Number

Imaging Sciences International LLC (dba Gendex LLC, DEXIS LLC) 1910 North Penn Rd. Hatfield, PA 19440

Contact Person Sanjay Ahuja, Ph.D. Email: sanjay.ahuja@kavokerrgroup.com Telephone: (267) 954-1463 Fax: (215) 997-5665.

Date Prepared

30 May 2014

Name of Device VixWin Platinum

Name/Address of Sponsor

Imaging Sciences International (dba Gendex LLC) 1910 North Penn Rd. Hatfield, PA 19440

Common or Usual Name Dental Imaging Device

Product Code LLZ

Classification Name System, Image Processing, Radiology, per 21 CFR §892.2050.

Predicate Devices

VixWin PRO (K060178)

Intended Use / Indications for Use

Caution: Federal law restricts this device to sale by or on the order of a trained and qualified dentist or dental technician.

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Technological Characteristics

The following are the technological characteristics between the proposed version of Microsoft Windows (3.3) and the cleared version of the VixWin Platinum Software (K060178).

Component/Functionality	VixWin PRO (K060178)	VixWin Platinum (Proposed)
Indication for Use	VixWin PRO controls capture, display, treatment, analysis and saving of X-ray digital images from DenOptix®, Visualix ® /GX-S, Orthoralix9200 DPI and DDE digital imaging systems produced by Gendex. It can also handle other types of digital images, e.g. color images from an intraoral or extraoral dental camera, such as the Gendex Concept IV series, or images acquired by digitizing film with a flatbed- scanner	VixWin Platinum is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.
Implementation	software only	Software only
Host Platform	PC	PC
Operating System	N/A	Windows 8 professional (32/64-bit)
	Windows 98, 2000, and XP ®	Windows XP professional (32-bits)
	N/A	Windows Vista Business (32-bits)
	N/A	Windows Server 2003
	N/A	Windows Server 2008
	N/A	Windows 7 Professional (32/64-bits}
Host RAM	32MB	1024 MB minimum, 2048MB recommended
Host storage	4GB minimum, 9GB or more recommended	30GB minimum, 200GB recommended
Host floppy drives	Not required	Not required
Installation Media	CD-ROM	DVD or Network
Host Processor Speed	Pentium 133 MHz, 300 MHz or faster recommended	Pentium 4 2.0 GHz min, Pentium 4 3.2 GHz recommended
Host Monitor Size	SVGA, XGA recommended	SVGA with 0.25/0.26 dot pitch
Display resolution	800 x 600 true color, 1024 x768 true color recommended	1024 x 768 24 bit true color min, 32 bit true color recommended
User DisplayPreferences	Yes	Yes
USB and S Videosupport	Yes	Yes
Receive Images fromother Systems?	Yes	Yes
Images Displayed	Dental X-rays, intraoral Images	Dental X-rays, intraoral and extraoral Images
Safety Standards	Not applicable. Software only supplied	Not applicable. Software only supplied

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Controls scanning and intake of x-ray images from imaging plates with the Photo-Stimulable ● Phosphor (PSP) scanners.
Controls the direct capture of x-ray images from intra-oral sensors and extra-oral systems. ●
Allows View and capture color images from intra-oral and extra-oral cameras. ●
. Export and import digital images (such as those obtained by scanning a film).
. Process images with dental specific tools to enhance their diagnostic value.
. Analyze and enhance images to gather additional diagnostic information which may not be immediately apparent on initial visual inspection.
Obtaining and storing patient data pertaining to those images
Both the viewing of the images and storage of the images and their associated data. ●
Managing (locally and remotely) a database of patients and related data.
Allows the update of existing patient information and the creation and storage of new patient information in a database over the network.
. Allows access to patient files from multiple workstations via network connectivity.
. Allows printing images and image related information over the network.

Substantial Equivalence

The VixWin Platinum Software with the new proposed Indications for Use described in this submission is substantially equivalent to the VixWin PRO software cleared under K0610178 and satisfy all criteria of substantial equivalence based upon the above comparisons in the sections and do not raise new concerns in safety and effectiveness: (1) Indications for Use, (2) Technological Characteristics, and (3) Theory of Operations. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is safe and effective. All internal verification and validation has been completed.

Performance Data

The current version of VixWin Platinum performs equivalently in functionality as the cleared Vix Win PRO (K060178). Performance data (Verification and Validation) demonstrate that VixWin Platinum functions equivalently to the predicate devices. Thus, the Vix Win Platinum (proposed) is substantially equivalent to the cleared VixWin PRO (K060178).

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).