Visix Imaging is a clinical software application that receives images and data from various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). Visix Imaging is intended to acquire, display, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images, plus store clinical notes in the form of annotations and measurements, using standard PC hardware. Visix Imaging is currently intended for dental use. It is not intended for mammography use.

Device Description

Visix Imaging is an image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. Visix Imaging runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a USB port, parallel port, S-video port on a video capture card, or SCSI card.

AI/ML Overview

The provided text is a 510(k) Summary for the Visix Imaging system, which is a Picture Archiving and Communication System (PACS). This document serves to demonstrate substantial equivalence to predicate devices, not to present a de novo study with acceptance criteria and a detailed performance evaluation of a new algorithm.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

Nature of the Submission: This is a 510(k) premarket notification. For devices like PACS, substantial equivalence is often established through technological comparison to legally marketed predicate devices, rather than extensive clinical efficacy studies with predefined acceptance criteria for AI algorithms. The "Testing" section explicitly states: "Visix Imaging has been demonstrated to perform as intended," which implies verification and validation activities (e.g., software testing, compatibility testing) against design specifications, but not a clinical performance study with statistical endpoints.
Device Type: Visix Imaging is an image management system (PACS), designed to acquire, display, edit, review, store, print, and distribute medical images. It is not an AI diagnostic algorithm or a CAD (Computer-Aided Detection/Diagnosis) system that would typically require performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement for an AI performance study is not available in this document because such a study was not conducted or required for this type of 510(k) submission.

However, I can extract the following information pertinent to the submission context:

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

Acceptance Criteria: The document does not explicitly list quantitative acceptance criteria in terms of clinical performance metrics for an AI algorithm. The implicit acceptance criterion for this 510(k) submission is that the device is "substantially equivalent" to predicate devices, meaning it performs as intended as a PACS system with similar indications for use and technological characteristics.
Reported Device Performance: "Visix Imaging has been demonstrated to perform as intended." This statement refers to the successful completion of verification and validation activities to ensure the software functions correctly as an image management system. No specific performance metrics (e.g., accuracy, sensitivity, specificity) against a clinical gold standard are provided for an AI component because it's not an AI diagnostic device in this context.

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: As this is a PACS system and not an AI diagnostic algorithm requiring a test set for performance evaluation against a ground truth, no such sample size or data provenance details are given. The "Testing" mentioned would have been internal software validation and verification.

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 by experts is not described, as there was no clinical performance study of an AI algorithm in this submission.

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

Not Applicable / Not Provided: No adjudication method is mentioned as there was no test set requiring expert adjudication for AI performance 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:

No: An MRMC comparative effectiveness study was not conducted or reported. The device is a PACS system, not an AI-assisted diagnostic tool for which such a study would be relevant.

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

Not Applicable / Not Provided: This device is a PACS system; it's not presented as a standalone diagnostic algorithm.

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

Not Applicable / Not Provided: No ground truth in the context of clinical disease status is mentioned, as there was no clinical validation study of an AI algorithm. For a PACS system, the "ground truth" would relate to its functionality, such as accurately displaying images or correctly performing edits, which are verified through software testing rather than clinical endpoints.

8. The sample size for the training set:

NotApplicable / Not Provided: This document does not describe the development or training of an AI algorithm; therefore, no training set size is mentioned.

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

Not Applicable / Not Provided: Not applicable for the reasons stated above.

Summary of Device and its Purpose based on the text:

Device Name: Visix Imaging
Classification Name: System, Image Processing, Radiological, 21 CFR 892.2050
Intended Use: Acquire, display, edit (e.g., resize, adjust contrast, annotate), review, store, print, and distribute medical images, plus store clinical notes in the form of annotations and measurements, using standard PC hardware. Intended for dental use, not mammography.
Technological Comparison (for substantial equivalence): Compared to Televere Systems' TigerView Professional (K061035), EagleSoft ChairSide Software Application (K982422), and Tau Corp.'s TigerScan/TigerView (K955237). All are software applications with similar indications for use and functions as PACS systems.
Conclusion of 510(k) Notice: Visix Imaging is substantially equivalent to legally marketed Picture Archiving and Communications Systems.

Summary

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1082623

Televere Systems Section 005_510(k) Summary 510(k) Premarket Notification

Visix Imaging Page 1 of 2

CONFIDENTIAL

510(k) SUMMARY

FEB 2 5 2009

General Information

Submitted by:

Televere Systems 1611 Center Avenue Janesville, WI 53545

Phone: 800-385-9593 Fax: 608-314-1084

Contact Person:

Barbara Deay 471 Stage Road Charlton, NY 12019

Phone: 800-385-9593 x128 408-762-2760 Fax: Email: barb@tigerview.com

Date Prepared:

August 29, 2008

Device Name

Trade Name: Visix Imaging Common Name: Picture archiving and communications system Classification Name: System, Image Processing, Radiological, 21 CFR 892.2050

Predicate Device

Manufacturer	Product Name	510(k) No.
Televere Systems	TigerView Professional	K061035
EagleSoft	EagleSoft ChairSide SoftwareApplication	K982422
Tau Corp. (purchased byTelevere Systems)	TigerScan/TigerView	K955237

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Televere Systems Section 005_510(k) Summary Visix Imaging Page 2 of 2

CONFIDENTIAL

Device Description

Intended Use

Technological Comparison

Visix Imaging, Tiger View Professional, Tiger View, and EagleSoft ChairSide are each software applications that have similar indications for use and overall function and perform in a similar manner with respect to image processing systems (i.e. PACS).

Testing

Visix Imaging has been demonstrated to perform as intended.

Conclusions

Visix Imaging is substantially equivalent to legally marketed Picture Archiving and Communications Systems.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three arms or extensions, representing health and human services. The overall design is simple and recognizable, conveying the department's role and purpose.

DEPARTMENT OF HEALTH & HUMAN SERVICES

· Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2009

Televere Systems % Ms. Barbara Deay . Technical Support and Writing Televere Systems 471 Stage Road CHARLTON NY 12019

Re: K082623

Trade/Device Name: Visix Imaging Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 11, 2009 Received: January 14, 2009

Dear Ms. Deay:

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. Drue, 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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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; 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx
21 CFR 884.xxx
21 CFR 892.xxx
Other

(Gastroenterology/Renal/Urology) (240) 276-0115 (Obstetrics/Gynecology) (240) 276-0115 (Radiology) (240) 276-0120 (240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification Televere Systems Section 004 _Indications for Use Statement

Visix Imaqinq Page 1 of 1

INDICATIONS FOR USE

510(k) Number (if known): K082623

Visix Imaging Device Name:

Sponsor Name: : Televere Systems

Indications for Use:

Prescription Use X (21 CFR 801 Subpart D)

And/Or

Over-The-Counter Use (21 CFR 807 Subpart C)

Do Not Write Below This Line - Continue on Another Page if Needed Concurrence of CDRH, Office of Device Evaluation (ODE)

Tony Thien

(Division Sign-Off) Division of Reproductive. Abdominal and Radiologics' " ﮨﮯ-------510(k) Num. ..

August 29, 2008

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).